Trial Outcomes & Findings for GLORIA-AF Registry Program - Second and Third Phases (NCT NCT01468701)
NCT ID: NCT01468701
Last Updated: 2021-03-29
Results Overview
Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.
Recruitment status
COMPLETED
Target enrollment
37235 participants
Primary outcome timeframe
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Results posted on
2021-03-29
Participant Flow
GLORIA-AF was an international, multicentre, non-interventional study based on prospectively collected data for patients (pts) with newly diagnosed non-valvular atrial fibrillation (NVAF). In Ph II, pts baseline characteristics (BC), their antithrombotic treatment patterns and outcomes with 2 years of follow-up for dabigatran alone were collected prospectively. Ph III collected prospective data on pts BC, their treatments and outcomes with 3 years of follow-up for all pts in real-world setting.
All patients were screened for eligibility prior to participation in the study. Patients attended a participating site which ensured that they (the patients) strictly met all inclusion and none of the exclusion criteria.
Participant milestones
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase II)
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Rivaroxaban - Baseline (Phase II)
Patients who were prescribed Rivaroxaban at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Apixaban - Baseline (Phase II)
Patients who were prescribed Apixaban at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Acetylsalicylic Acid (ASA) - Baseline (Phase II)
Patients who were prescribed Acetylsalicylic acid (ASA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Antiplts Other Than ASA - Baseline (Phase II)
Patients who were prescribed Antiplts other than Acetylsalicylic acid (ASA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
No Treatment - Baseline (Phase II)
Patients who were not prescribed any antithrombotic treatments at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Combinations With Oral Anticoagulants - Baseline (Phase II)
Patients who were prescribed combinations with oral anticoagulants treatments at baseline of Phase III were included in this group. Patients in this group were not included in the safety analysis as no specific treatment can be defined.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Dabigatran Etexilate - Baseline (Phase III)
Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Rivaroxaban - Baseline (Phase III)
Patients who were prescribed Rivaroxaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Apixaban - Baseline (Phase III)
Patients who were prescribed Apixaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Edoxaban - Baseline (Phase III)
Patients who were prescribed Edoxaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Acetylsalicylic Acid (ASA) - Baseline (Phase III)
Patients who were prescribed Acetylsalicylic acid (ASA) at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Antiplts Other Than ASA - Baseline (Phase III)
Patients who were prescribed Antiplatelets other than ASA at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may be used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
No Treatment - Baseline (Phase III)
Patients who were not prescribed any antithrombotic treatments at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Combinations With Oral Anticoagulants - Baseline (Phase III)
Patients who were prescribed combinations with oral anticoagulants treatments at baseline of Phase III were included in this group. Patients in this group were not included in the safety analysis as no specific treatment can be defined.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4964
|
5103
|
1784
|
715
|
1736
|
128
|
1209
|
5
|
3879
|
4962
|
4054
|
4538
|
333
|
2182
|
214
|
1418
|
11
|
|
Overall Study
All Eligible Patient
|
4873
|
4963
|
1755
|
703
|
1714
|
126
|
1170
|
4
|
3839
|
4836
|
4015
|
4505
|
332
|
2163
|
213
|
1386
|
11
|
|
Overall Study
COMPLETED
|
3965
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3219
|
3780
|
3256
|
3672
|
284
|
1712
|
151
|
1056
|
10
|
|
Overall Study
NOT COMPLETED
|
999
|
5103
|
1784
|
715
|
1736
|
128
|
1209
|
5
|
660
|
1182
|
798
|
866
|
49
|
470
|
63
|
362
|
1
|
Reasons for withdrawal
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase II)
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Rivaroxaban - Baseline (Phase II)
Patients who were prescribed Rivaroxaban at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Apixaban - Baseline (Phase II)
Patients who were prescribed Apixaban at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Acetylsalicylic Acid (ASA) - Baseline (Phase II)
Patients who were prescribed Acetylsalicylic acid (ASA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Antiplts Other Than ASA - Baseline (Phase II)
Patients who were prescribed Antiplts other than Acetylsalicylic acid (ASA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
No Treatment - Baseline (Phase II)
Patients who were not prescribed any antithrombotic treatments at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Combinations With Oral Anticoagulants - Baseline (Phase II)
Patients who were prescribed combinations with oral anticoagulants treatments at baseline of Phase III were included in this group. Patients in this group were not included in the safety analysis as no specific treatment can be defined.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Dabigatran Etexilate - Baseline (Phase III)
Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Rivaroxaban - Baseline (Phase III)
Patients who were prescribed Rivaroxaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Apixaban - Baseline (Phase III)
Patients who were prescribed Apixaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Edoxaban - Baseline (Phase III)
Patients who were prescribed Edoxaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Acetylsalicylic Acid (ASA) - Baseline (Phase III)
Patients who were prescribed Acetylsalicylic acid (ASA) at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Antiplts Other Than ASA - Baseline (Phase III)
Patients who were prescribed Antiplatelets other than ASA at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may be used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
No Treatment - Baseline (Phase III)
Patients who were not prescribed any antithrombotic treatments at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Combinations With Oral Anticoagulants - Baseline (Phase III)
Patients who were prescribed combinations with oral anticoagulants treatments at baseline of Phase III were included in this group. Patients in this group were not included in the safety analysis as no specific treatment can be defined.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Not eligible
|
91
|
140
|
29
|
12
|
22
|
2
|
39
|
1
|
40
|
126
|
39
|
33
|
1
|
19
|
1
|
32
|
0
|
|
Overall Study
Lost to Follow-up
|
306
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
215
|
309
|
224
|
212
|
11
|
164
|
17
|
127
|
1
|
|
Overall Study
Withdrawal by Subject
|
165
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
83
|
88
|
100
|
114
|
9
|
47
|
6
|
31
|
0
|
|
Overall Study
Other reasons than listed
|
437
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
318
|
658
|
433
|
504
|
28
|
239
|
39
|
172
|
0
|
|
Overall Study
No end of study case report form
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
1
|
2
|
3
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Not being followed up
|
0
|
4963
|
1755
|
703
|
1714
|
126
|
1170
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
GLORIA-AF Registry Program - Second and Third Phases
Baseline characteristics by cohort
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=4873 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase II)
n=4963 Participants
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Rivaroxaban - Baseline (Phase II)
n=1755 Participants
Patients who were prescribed Rivaroxaban at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Apixaban - Baseline (Phase II)
n=703 Participants
Patients who were prescribed Apixaban at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Acetylsalicylic Acid (ASA) - Baseline (Phase II)
n=1714 Participants
Patients who were prescribed Acetylsalicylic acid (ASA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Antiplts Other Than ASA - Baseline (Phase II)
n=126 Participants
Patients who were prescribed Antiplts other than Acetylsalicylic acid (ASA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
No Treatment - Baseline (Phase II)
n=1170 Participants
Patients who were not prescribed any antithrombotic treatments at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Combinations With Oral Anticoagulants - Baseline (Phase II)
n=4 Participants
Patients who were prescribed combinations with oral anticoagulants treatments at baseline of Phase II were included in this group. Patients in this group were not included in the safety analysis as no specific treatment can be defined.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Dabigatran Etexilate - Baseline (Phase III)
n=3839 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
n=4836 Participants
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Rivaroxaban - Baseline (Phase III)
n=4015 Participants
Patients who were prescribed Rivaroxaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Apixaban - Baseline (Phase III)
n=4505 Participants
Patients who were prescribed Apixaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Edoxaban - Baseline (Phase III)
n=332 Participants
Patients who were prescribed Edoxaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Acetylsalicylic Acid (ASA) - Baseline (Phase III)
n=2163 Participants
Patients who were prescribed Acetylsalicylic acid (ASA) at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Antiplts Other Than ASA - Baseline (Phase III)
n=213 Participants
Patients who were prescribed Antiplatelets other than ASA at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may be used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
No Treatment - Baseline (Phase III)
n=1386 Participants
Patients who were not prescribed any antithrombotic treatments at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Combinations With Oral Anticoagulants - Baseline (Phase III)
n=11 Participants
Patients who were prescribed combinations with oral anticoagulants treatments at baseline of Phase III were included in this group. Patients in this group were not included in the safety analysis as no specific treatment can be defined.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Total
n=36608 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
70.2 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
71.4 Years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
71.5 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
73.8 Years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
67.7 Years
STANDARD_DEVIATION 12.4 • n=21 Participants
|
73.5 Years
STANDARD_DEVIATION 10.7 • n=10 Participants
|
68.3 Years
STANDARD_DEVIATION 12.5 • n=115 Participants
|
76.0 Years
STANDARD_DEVIATION 8.3 • n=6 Participants
|
70.1 Years
STANDARD_DEVIATION 10.2 • n=6 Participants
|
71.2 Years
STANDARD_DEVIATION 10.3 • n=64 Participants
|
70.3 Years
STANDARD_DEVIATION 10.2 • n=17 Participants
|
72.4 Years
STANDARD_DEVIATION 10.1 • n=21 Participants
|
72.3 Years
STANDARD_DEVIATION 9.4 • n=22 Participants
|
68.0 Years
STANDARD_DEVIATION 11.8 • n=8 Participants
|
73.1 Years
STANDARD_DEVIATION 10.8 • n=16 Participants
|
67.6 Years
STANDARD_DEVIATION 12.2 • n=135 Participants
|
70.2 Years
STANDARD_DEVIATION 12.1 • n=136 Participants
|
70.5 Years
STANDARD_DEVIATION 10.8 • n=44 Participants
|
|
Sex: Female, Male
Female
|
2162 Participants
n=5 Participants
|
2304 Participants
n=7 Participants
|
773 Participants
n=5 Participants
|
338 Participants
n=4 Participants
|
778 Participants
n=21 Participants
|
58 Participants
n=10 Participants
|
553 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
1718 Participants
n=6 Participants
|
2152 Participants
n=64 Participants
|
1766 Participants
n=17 Participants
|
2104 Participants
n=21 Participants
|
139 Participants
n=22 Participants
|
931 Participants
n=8 Participants
|
92 Participants
n=16 Participants
|
660 Participants
n=135 Participants
|
6 Participants
n=136 Participants
|
16536 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
2711 Participants
n=5 Participants
|
2659 Participants
n=7 Participants
|
982 Participants
n=5 Participants
|
365 Participants
n=4 Participants
|
936 Participants
n=21 Participants
|
68 Participants
n=10 Participants
|
617 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
2121 Participants
n=6 Participants
|
2684 Participants
n=64 Participants
|
2249 Participants
n=17 Participants
|
2401 Participants
n=21 Participants
|
193 Participants
n=22 Participants
|
1232 Participants
n=8 Participants
|
121 Participants
n=16 Participants
|
726 Participants
n=135 Participants
|
5 Participants
n=136 Participants
|
20072 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
27 Participants
n=6 Participants
|
32 Participants
n=64 Participants
|
32 Participants
n=17 Participants
|
21 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
7 Participants
n=8 Participants
|
2 Participants
n=16 Participants
|
3 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
170 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
Asian
|
423 Participants
n=5 Participants
|
797 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
694 Participants
n=21 Participants
|
43 Participants
n=10 Participants
|
603 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
841 Participants
n=6 Participants
|
760 Participants
n=64 Participants
|
381 Participants
n=17 Participants
|
413 Participants
n=21 Participants
|
125 Participants
n=22 Participants
|
916 Participants
n=8 Participants
|
95 Participants
n=16 Participants
|
593 Participants
n=135 Participants
|
8 Participants
n=136 Participants
|
6896 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
40 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
47 Participants
n=6 Participants
|
85 Participants
n=64 Participants
|
72 Participants
n=17 Participants
|
118 Participants
n=21 Participants
|
2 Participants
n=22 Participants
|
49 Participants
n=8 Participants
|
2 Participants
n=16 Participants
|
23 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
647 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific Islander
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
9 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
White
|
3372 Participants
n=5 Participants
|
3590 Participants
n=7 Participants
|
1375 Participants
n=5 Participants
|
538 Participants
n=4 Participants
|
863 Participants
n=21 Participants
|
70 Participants
n=10 Participants
|
497 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
2484 Participants
n=6 Participants
|
3611 Participants
n=64 Participants
|
3126 Participants
n=17 Participants
|
3528 Participants
n=21 Participants
|
203 Participants
n=22 Participants
|
1057 Participants
n=8 Participants
|
104 Participants
n=16 Participants
|
708 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
25132 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
Other
|
447 Participants
n=5 Participants
|
262 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
181 Participants
n=6 Participants
|
144 Participants
n=64 Participants
|
144 Participants
n=17 Participants
|
79 Participants
n=21 Participants
|
2 Participants
n=22 Participants
|
57 Participants
n=8 Participants
|
7 Participants
n=16 Participants
|
32 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1561 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
Missing
|
571 Participants
n=5 Participants
|
211 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
259 Participants
n=6 Participants
|
204 Participants
n=64 Participants
|
260 Participants
n=17 Participants
|
345 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
75 Participants
n=8 Participants
|
3 Participants
n=16 Participants
|
27 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
2193 Participants
n=44 Participants
|
PRIMARY outcome
Timeframe: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.Population: All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=4859 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase II
|
2.06 Events per 100 person-years
Interval 1.74 to 2.42
|
—
|
PRIMARY outcome
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.Population: Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown cause of death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=3611 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
n=4413 Participants
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase III
|
2.21 Events per 100 person-years
Interval 1.88 to 2.57
|
3.23 Events per 100 person-years
Interval 2.83 to 3.62
|
PRIMARY outcome
Timeframe: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.Population: All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=4859 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase II
|
1.74 Events per 100 person-years
Interval 1.45 to 2.07
|
—
|
PRIMARY outcome
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.Population: Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=3611 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
n=4413 Participants
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase III
|
1.91 Events per 100 person-years
Interval 1.59 to 2.24
|
2.62 Events per 100 person-years
Interval 2.27 to 2.96
|
PRIMARY outcome
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.Population: Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=3611 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
n=4413 Participants
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of Stroke or Systemic Embolism - Phase III
|
0.80 Events per 100 person-years
Interval 0.61 to 1.01
|
1.00 Events per 100 person-years
Interval 0.8 to 1.22
|
PRIMARY outcome
Timeframe: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.Population: All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Incidence rate of stroke on all eligible patients excluding prescribed but not taken set for Dabigatran etexilate (DE) of phase II only is presented. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=4859 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of Stroke - Phase II
|
0.65 Events per 100 person-years
Interval 0.48 to 0.87
|
—
|
PRIMARY outcome
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.Population: Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=3611 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
n=4413 Participants
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of Stroke - Phase III
|
0.77 Events per 100 person-years
Interval 0.58 to 0.97
|
0.96 Events per 100 person-years
Interval 0.76 to 1.17
|
PRIMARY outcome
Timeframe: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.Population: All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Incidence rate of transient ischaemic attack (TIA) on on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=4859 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of Transient Ischaemic Attack (TIA) - Phase II
|
0.21 Events per 100 person-years
Interval 0.12 to 0.34
|
—
|
PRIMARY outcome
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.Population: Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=3611 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
n=4413 Participants
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of Transient Ischaemic Attack (TIA) - Phase III
|
0.29 Events per 100 person-years
Interval 0.17 to 0.42
|
0.32 Events per 100 person-years
Interval 0.21 to 0.45
|
PRIMARY outcome
Timeframe: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.Population: All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Incidence rate of systemic embolism (SE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=4859 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of Systemic Embolism (SE) - Phase II
|
0.04 Events per 100 person-years
Interval 0.01 to 0.12
|
—
|
PRIMARY outcome
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.Population: Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Incidence rate of systemic embolism (SE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=3611 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
n=4413 Participants
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of Systemic Embolism (SE) - Phase III
|
0.04 Events per 100 person-years
Interval 0.0 to 0.09
|
0.05 Events per 100 person-years
Interval 0.01 to 0.09
|
PRIMARY outcome
Timeframe: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.Population: All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Incidence rate of pulmonary embolism (PE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=4859 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of Pulmonary Embolism (PE) - Phase II
|
0.07 Events per 100 person-years
Interval 0.02 to 0.16
|
—
|
PRIMARY outcome
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.Population: Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=3611 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
n=4413 Participants
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of Pulmonary Embolism (PE) - Phase III
|
0.07 Events per 100 person-years
Interval 0.01 to 0.13
|
0.06 Events per 100 person-years
Interval 0.01 to 0.11
|
PRIMARY outcome
Timeframe: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.Population: All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Incidence rate of major bleeding events (MBE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=4859 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of Major Bleeding Events (MBE) - Phase II
|
0.97 Events per 100 person-years
Interval 0.76 to 1.23
|
—
|
PRIMARY outcome
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.Population: Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=3611 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
n=4413 Participants
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of Major Bleeding Events (MBE) - Phase III
|
0.69 Events per 100 person-years
Interval 0.51 to 0.89
|
1.44 Events per 100 person-years
Interval 1.2 to 1.7
|
PRIMARY outcome
Timeframe: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.Population: All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Incidence rate of life-threatening bleeding events on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=4859 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of Life-threatening Bleeding Events - Phase II
|
0.46 Events per 100 person-years
Interval 0.32 to 0.64
|
—
|
PRIMARY outcome
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.Population: Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=3611 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
n=4413 Participants
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of Life-threatening Bleeding Events - Phase III
|
0.47 Events per 100 person-years
Interval 0.32 to 0.63
|
1.07 Events per 100 person-years
Interval 0.86 to 1.3
|
PRIMARY outcome
Timeframe: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.Population: All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Incidence rate of myocardial infarction (MI) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=4859 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of Myocardial Infarction (MI) - Phase II
|
0.50 Events per 100 person-years
Interval 0.35 to 0.69
|
—
|
PRIMARY outcome
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.Population: Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=3611 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
n=4413 Participants
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of Myocardial Infarction (MI) - Phase III
|
0.40 Events per 100 person-years
Interval 0.27 to 0.55
|
0.53 Events per 100 person-years
Interval 0.38 to 0.68
|
PRIMARY outcome
Timeframe: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.Population: All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Incidence rate of all-cause death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=4859 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of All-cause Death - Phase II
|
2.48 Events per 100 person-years
Interval 2.13 to 2.87
|
—
|
PRIMARY outcome
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.Population: Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=3611 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
n=4413 Participants
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of All-cause Death - Phase III
|
2.16 Events per 100 person-years
Interval 1.84 to 2.48
|
3.57 Events per 100 person-years
Interval 3.19 to 3.96
|
PRIMARY outcome
Timeframe: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.Population: All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Incidence rate of vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=4859 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of Vascular Death - Phase II
|
0.85 Events per 100 person-years
Interval 0.65 to 1.09
|
—
|
PRIMARY outcome
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.Population: Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Outcome measures
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=3611 Participants
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Vitamin K Antagonist (VKA) - Baseline (Phase III)
n=4413 Participants
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
|---|---|---|
|
Incidence Rate of Vascular Death - Phase III
|
0.75 Events per 100 person-years
Interval 0.56 to 0.95
|
1.26 Events per 100 person-years
Interval 1.03 to 1.5
|
Adverse Events
Dabigatran Etexilate - Baseline (Phase II)
Serious events: 985 serious events
Other events: 0 other events
Deaths: 184 deaths
Dabigatran Etexilate - at Least Once During Phase III of the Study
Serious events: 118 serious events
Other events: 0 other events
Deaths: 199 deaths
Vitamin K Antagonist (VKA) - at Least Once During Phase III of the Study
Serious events: 296 serious events
Other events: 0 other events
Deaths: 465 deaths
Rivaroxaban - at Least Once During Phase III of the Study
Serious events: 185 serious events
Other events: 0 other events
Deaths: 292 deaths
Apixaban - at Least Once During Phase III of the Study
Serious events: 217 serious events
Other events: 0 other events
Deaths: 392 deaths
Edoxaban - at Least Once During Phase III of the Study
Serious events: 16 serious events
Other events: 0 other events
Deaths: 23 deaths
Acetylsalicylic Acid (ASA) - at Least Once During Phase III of the Study
Serious events: 225 serious events
Other events: 0 other events
Deaths: 469 deaths
Antiplts Other Than ASA - at Least Once During Phase III of the Study
Serious events: 19 serious events
Other events: 0 other events
Deaths: 46 deaths
Serious adverse events
| Measure |
Dabigatran Etexilate - Baseline (Phase II)
n=4943 participants at risk
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
|
Dabigatran Etexilate - at Least Once During Phase III of the Study
n=4477 participants at risk
All patients who received at least once dabigatran etexilate during phase III of the study were included in the group. Adverse events which happened when the patients received dabigatran etexilate were reported in this group.
Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.
|
Vitamin K Antagonist (VKA) - at Least Once During Phase III of the Study
n=5894 participants at risk
All patients who received at least once Vitamin K Antagonist (VKA) during phase III of the study were included in the group. Adverse events which happened when the patients received Vitamin K Antagonist (VKA) were reported in this group.
Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.
|
Rivaroxaban - at Least Once During Phase III of the Study
n=5177 participants at risk
All patients who received at least once Rivaroxaban during phase III of the study were included in the group. Adverse events which happened when the patients received Rivaroxaban were reported in this group.
Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.
|
Apixaban - at Least Once During Phase III of the Study
n=6024 participants at risk
All patients who received at least once Apixaban during phase III of the study were included in the group. Adverse events which happened when the patients received Apixaban were reported in this group.
Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.
|
Edoxaban - at Least Once During Phase III of the Study
n=686 participants at risk
All patients who received at least once Edoxaban during phase III of the study were included in the group. Adverse events which happened when the patients received Edoxaban were reported in this group.
Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.
|
Acetylsalicylic Acid (ASA) - at Least Once During Phase III of the Study
n=6263 participants at risk
All patients who received at least once Acetylsalicylic acid (ASA) during phase III of the study were included in the group. Adverse events which happened when the patients received Acetylsalicylic acid (ASA) were reported in this group.
Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.
|
Antiplts Other Than ASA - at Least Once During Phase III of the Study
n=780 participants at risk
All patients who received at least once Antiplts other than ASA during phase III of the study were included in the group. Adverse events which happened when the patients received Antiplts other than ASA were reported in this group.
Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Prinzmetal angina
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.24%
12/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.13%
6/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.27%
16/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.23%
12/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.32%
19/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.31%
2/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.30%
19/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.04%
2/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.15%
9/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.08%
4/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.07%
4/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.16%
1/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.11%
7/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.06%
3/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Blood and lymphatic system disorders
Splenic haematoma
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.05%
3/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.22%
11/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Angina pectoris
|
0.40%
20/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Angina unstable
|
0.22%
11/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Atrial fibrillation
|
3.2%
159/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.05%
3/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.04%
2/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.05%
3/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Atrial flutter
|
0.18%
9/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Atrial thrombosis
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Bradycardia
|
0.28%
14/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Cardiac arrest
|
0.18%
9/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Cardiac failure
|
1.4%
67/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.07%
3/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.07%
4/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.83%
41/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Cardiac tamponade
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Cardiomyopathy alcoholic
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Myocardial infarction
|
0.55%
27/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.04%
2/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Palpitations
|
0.18%
9/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Pericardial effusion
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Pericarditis
|
0.08%
4/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Congenital, familial and genetic disorders
Haemorrhagic arteriovenous malformation
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Ear and labyrinth disorders
Vertigo
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Eye disorders
Eye haemorrhage
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Eye disorders
Retinal artery embolism
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Eye disorders
Retinal vascular occlusion
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.10%
5/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Discoloured vomit
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.16%
1/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Duodenal varices
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.04%
2/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.04%
2/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.05%
3/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.05%
3/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.06%
3/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.05%
3/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.16%
1/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Gastritis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.49%
24/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.36%
16/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.46%
27/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.70%
36/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.43%
26/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.47%
3/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.69%
43/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.51%
4/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Gastrointestinal polyp haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Gastrointestinal vascular malformation haemorrhagic
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Haematemesis
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.04%
2/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.05%
3/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Haematochezia
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.07%
3/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.04%
2/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.05%
3/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.06%
4/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.08%
4/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.10%
5/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.27%
12/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.19%
11/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.41%
21/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.17%
10/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.16%
1/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.32%
20/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.38%
3/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Melaena
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.12%
6/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Mesenteric haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Nausea
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.16%
8/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.13%
6/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.14%
8/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.12%
6/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.12%
7/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.31%
2/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.13%
8/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.13%
1/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.12%
6/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.18%
8/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.31%
18/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.15%
8/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.20%
12/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.14%
9/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.51%
4/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Vomiting
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Vomiting projectile
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Asthenia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Chest pain
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Death
|
0.97%
48/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Medical device site haematoma
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.12%
6/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Non-cardiac chest pain
|
0.20%
10/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Oedema peripheral
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Puncture site haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Pyrexia
|
0.08%
4/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Sudden death
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Suprapubic pain
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Hepatobiliary disorders
Hepatic haematoma
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Bronchitis
|
0.08%
4/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Cellulitis
|
0.14%
7/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Cystitis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Diverticulitis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Diverticulitis intestinal haemorrhagic
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Empyema
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Gastroenteritis
|
0.10%
5/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.04%
2/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Pneumonia
|
0.83%
41/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.04%
2/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Sepsis
|
0.18%
9/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Urinary tract infection
|
0.14%
7/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Urosepsis
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Fall
|
0.16%
8/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.14%
8/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.04%
2/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.07%
4/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.08%
5/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.10%
5/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.10%
6/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.13%
1/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.05%
3/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.10%
5/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.06%
4/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.13%
1/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.05%
3/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.04%
2/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Splenic injury
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.08%
4/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.09%
4/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.22%
13/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.11%
7/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.04%
2/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.05%
3/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.15%
9/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.06%
4/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.16%
1/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Right ventricular failure
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Traumatic renal injury
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.12%
7/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Investigations
Anticoagulation drug level below therapeutic
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Investigations
Bleeding time prolonged
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Investigations
Blood urine present
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Investigations
Catheterisation cardiac
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.04%
2/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.12%
7/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Investigations
Liver function test increased
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Investigations
Occult blood
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Investigations
Transaminases increased
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.04%
2/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.08%
5/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.07%
4/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.24%
12/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.12%
6/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.16%
8/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcomatoid carcinoma
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.16%
1/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Cerebellar stroke
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.08%
4/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.17%
10/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.06%
3/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.08%
5/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.16%
1/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.08%
5/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Cerebral infarction
|
0.14%
7/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.05%
3/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.40%
20/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.15%
9/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.12%
7/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.08%
5/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Dizziness
|
0.14%
7/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.31%
2/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.05%
3/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.17%
10/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.08%
4/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.08%
5/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.04%
2/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.12%
7/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.08%
4/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.08%
5/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Headache
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Intracranial haematoma
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.13%
1/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Ischaemic stroke
|
0.38%
19/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.16%
7/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.15%
9/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.06%
3/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.08%
5/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.10%
6/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.26%
2/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Presyncope
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.05%
3/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.04%
2/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.07%
4/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Syncope
|
0.36%
18/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.04%
2/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.30%
15/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.11%
5/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.22%
13/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.10%
5/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.12%
7/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.08%
5/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Vascular dementia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.10%
5/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Haematuria
|
0.08%
4/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.07%
3/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.20%
12/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.19%
10/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.08%
5/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.10%
6/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Hypertensive nephropathy
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Renal haematoma
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Urinary retention
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Urogenital haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.12%
7/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Reproductive system and breast disorders
Breast haematoma
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.16%
1/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.04%
2/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.06%
3/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.47%
23/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.07%
4/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.07%
3/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.32%
19/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.15%
8/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.13%
8/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.16%
1/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.13%
8/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.10%
5/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.08%
5/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.08%
5/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.06%
4/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.12%
6/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.10%
5/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Aneurysm
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Embolism arterial
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Haematoma
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.17%
10/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.07%
4/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.05%
3/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.13%
1/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.07%
3/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.14%
8/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.08%
4/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.17%
10/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.06%
4/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Hypovolaemic shock
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.03%
2/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Ischaemia
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Orthostatic hypotension
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Peripheral embolism
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Peripheral ischaemia
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Shock haemorrhagic
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Subgaleal haematoma
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Venous haemorrhage
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.02%
1/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.13%
1/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.13%
1/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Blood and lymphatic system disorders
Haemorrhagic disorder
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Blood and lymphatic system disorders
Normochromic anaemia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Blood and lymphatic system disorders
Splenic lesion
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.16%
8/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Arrhythmia
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Atrial tachycardia
|
0.10%
5/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Atrioventricular block
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Cardiac disorder
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Cardiac failure acute
|
0.12%
6/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.08%
4/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.10%
5/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Cardiogenic shock
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Cardiomegaly
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Cardiomyopathy
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Coronary artery disease
|
0.14%
7/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Left ventricular failure
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Myocardial fibrosis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Nodal arrhythmia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Pericarditis constrictive
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Sinoatrial block
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Sinus arrest
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Sinus bradycardia
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.32%
16/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.10%
5/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Tachycardia
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.10%
5/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Endocrine disorders
Hyperthyroidism
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Endocrine disorders
Hypothyroidism
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Endocrine disorders
Thyroid mass
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Eye disorders
Open angle glaucoma
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Anal fissure
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Dysphagia
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Faecaloma
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.08%
4/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Tongue haematoma
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Gastrointestinal disorders
Tooth pulp haemorrhage
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Cardiac death
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Catheter site haemorrhage
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Chest discomfort
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Fatigue
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Gait disturbance
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Hernia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Malaise
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Organ failure
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Pain
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Sudden cardiac death
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
General disorders
Ulcer
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Hepatobiliary disorders
Cholangitis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.12%
6/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Hepatobiliary disorders
Chronic hepatic failure
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Hepatobiliary disorders
Hepatic congestion
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Immune system disorders
Anaphylactic shock
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Appendicitis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Arthritis infective
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Clostridium difficile infection
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Diabetic foot infection
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Diarrhoea infectious
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Echinococciasis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Endocarditis
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Endocarditis bacterial
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Endophthalmitis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Erysipelas
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Infection
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Influenza
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Localised infection
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.12%
6/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Lyme disease
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Meningitis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Necrotising fasciitis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Paraspinal abscess
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Peritonitis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Post procedural infection
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Post procedural sepsis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Postoperative wound infection
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Pulmonary sepsis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Pyelonephritis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Respiratory tract infection
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Septic arthritis streptococcal
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Septic shock
|
0.14%
7/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Sinusitis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Streptococcal sepsis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Tracheobronchitis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Viral infection
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Infections and infestations
Wound infection
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Accident
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Electric shock
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.08%
4/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Intestinal anastomosis complication
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Pocket erosion
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Procedural shock
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Investigations
Blood creatinine increased
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Investigations
Blood glucose increased
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Investigations
Blood pressure increased
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Investigations
C-reactive protein increased
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Investigations
Glomerular filtration rate decreased
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Investigations
Haematocrit decreased
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Investigations
Heart rate increased
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Investigations
Troponin increased
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Investigations
White blood cell count increased
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Metabolism and nutrition disorders
Gout
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Metabolism and nutrition disorders
Obesity
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.08%
4/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.12%
6/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder adenocarcinoma
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant genitourinary tract neoplasm
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant respiratory tract neoplasm
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer stage IV
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma metastatic
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Aphasia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Balance disorder
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Brain stem infarction
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Cognitive disorder
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Coma
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Dementia
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Dysarthria
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Encephalopathy
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Epilepsy
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Hemiparesis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Hydrocephalus
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Hypoaesthesia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Intracranial mass
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Lacunar stroke
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Motor dysfunction
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Myelopathy
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Parkinson's disease
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Polyneuropathy
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Seizure
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Nervous system disorders
Spinal cord haematoma
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Product Issues
Device battery issue
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Product Issues
Device dislocation
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Product Issues
Device loosening
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Product Issues
Device malfunction
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Psychiatric disorders
Aggression
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Psychiatric disorders
Bipolar disorder
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Psychiatric disorders
Confusional state
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Psychiatric disorders
Delirium
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Psychiatric disorders
Derailment
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Psychiatric disorders
Homicidal ideation
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Psychiatric disorders
Mental status changes
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Psychiatric disorders
Restlessness
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Psychiatric disorders
Sleep disorder
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Psychiatric disorders
Stress
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Psychiatric disorders
Suicidal ideation
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Calculus bladder
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.08%
4/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Dysuria
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.12%
6/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Nephropathy
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Renal aneurysm
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Renal failure
|
0.24%
12/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Renal impairment
|
0.08%
4/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Reproductive system and breast disorders
Breast hyperplasia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.38%
19/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Social circumstances
Alcoholic
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Aortic stenosis
|
0.12%
6/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Circulatory collapse
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Hypertension
|
0.22%
11/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Hypertensive crisis
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Hypotension
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.06%
3/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.04%
2/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
|
Vascular disorders
Peripheral venous disease
|
0.02%
1/4943 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/4477 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5894 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/5177 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6024 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/636 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/6263 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
0.00%
0/780 • Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER