Trial Outcomes & Findings for Efficacy and Safety of Rivaroxaban for the Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation (NCT NCT00494871)
NCT ID: NCT00494871
Last Updated: 2015-04-20
Results Overview
Major bleeding: clinically overt bleeding (COB) associated with a fall in hemoglobin ≥2 g/dL, leading to transfusion ≥2 units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Non-major clinically relevant bleeding: COB that does not meet the definition of major bleeding, but requires medical intervention or unscheduled contact with the physician, (temporary) discontinuation of the study treatment, discomfort to the subject such as pain, or impairment of activities of daily life.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1280 participants
Primary outcome timeframe
Up to 2 days after the last dose
Results posted on
2015-04-20
Participant Flow
The first participant entered the study on 08 Jun 2007, and the last participant completed the study on 19 Jan 2010. The study was conducted at 167 centers in Japan. 164 study centers enrolled at least 1 participant.
In total, 1439 participants were screened for study eligibility; 159 participants were screening failures and were not randomized. Therefore, 1280 participants (640 in each group) were randomized.
Participant milestones
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
|
Warfarin
Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
|
|---|---|---|
|
Double-blind (DB) Treatment Period
STARTED
|
640
|
640
|
|
Double-blind (DB) Treatment Period
Started Treatment
|
639
|
639
|
|
Double-blind (DB) Treatment Period
COMPLETED
|
480
|
468
|
|
Double-blind (DB) Treatment Period
NOT COMPLETED
|
160
|
172
|
|
Follow-up (FU) Period
STARTED
|
639
|
639
|
|
Follow-up (FU) Period
Entered FU and Valid for Safety
|
628
|
630
|
|
Follow-up (FU) Period
COMPLETED
|
610
|
616
|
|
Follow-up (FU) Period
NOT COMPLETED
|
29
|
23
|
Reasons for withdrawal
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
|
Warfarin
Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
|
|---|---|---|
|
Double-blind (DB) Treatment Period
Adverse Event
|
73
|
70
|
|
Double-blind (DB) Treatment Period
Withdrawal by Subject
|
26
|
35
|
|
Double-blind (DB) Treatment Period
Death
|
8
|
3
|
|
Double-blind (DB) Treatment Period
Physician Decision
|
4
|
13
|
|
Double-blind (DB) Treatment Period
Lost to Follow-up
|
4
|
1
|
|
Double-blind (DB) Treatment Period
Protocol Violation
|
9
|
9
|
|
Double-blind (DB) Treatment Period
Clinical Endpoint Reached
|
18
|
28
|
|
Double-blind (DB) Treatment Period
Non-compliant with Study Medication
|
3
|
1
|
|
Double-blind (DB) Treatment Period
Protocol Driven Decision Point
|
12
|
8
|
|
Double-blind (DB) Treatment Period
Site Closed by Investigator
|
1
|
2
|
|
Double-blind (DB) Treatment Period
Site Closed by Sponsor
|
1
|
1
|
|
Double-blind (DB) Treatment Period
Drop out before Treatment Start
|
1
|
1
|
|
Follow-up (FU) Period
Adverse Event
|
1
|
1
|
|
Follow-up (FU) Period
Death
|
13
|
12
|
|
Follow-up (FU) Period
Lost to Follow-up
|
6
|
2
|
|
Follow-up (FU) Period
Physician Decision
|
0
|
1
|
|
Follow-up (FU) Period
Protocol Violation
|
1
|
0
|
|
Follow-up (FU) Period
Withdrawal by Subject
|
5
|
5
|
|
Follow-up (FU) Period
Clinical Endpoint Reached
|
3
|
2
|
Baseline Characteristics
Efficacy and Safety of Rivaroxaban for the Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=640 Participants
Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
|
Warfarin
n=640 Participants
Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
|
Total
n=1280 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.0 Years
STANDARD_DEVIATION 8.3 • n=113 Participants
|
71.2 Years
STANDARD_DEVIATION 7.9 • n=163 Participants
|
71.1 Years
STANDARD_DEVIATION 8.1 • n=160 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=113 Participants
|
140 Participants
n=163 Participants
|
250 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
530 Participants
n=113 Participants
|
500 Participants
n=163 Participants
|
1030 Participants
n=160 Participants
|
|
CL(CR) [creatinine clearance]
<50 mL/min
|
141 Participants
n=113 Participants
|
143 Participants
n=163 Participants
|
284 Participants
n=160 Participants
|
|
CL(CR) [creatinine clearance]
50 to <80 mL/min
|
329 Participants
n=113 Participants
|
329 Participants
n=163 Participants
|
658 Participants
n=160 Participants
|
|
CL(CR) [creatinine clearance]
≥80 mL/min
|
170 Participants
n=113 Participants
|
168 Participants
n=163 Participants
|
338 Participants
n=160 Participants
|
PRIMARY outcome
Timeframe: Up to 2 days after the last dosePopulation: The safety analysis population consisted of randomized participants who took at least one dose of study treatment (639 in each treatment group).
Major bleeding: clinically overt bleeding (COB) associated with a fall in hemoglobin ≥2 g/dL, leading to transfusion ≥2 units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Non-major clinically relevant bleeding: COB that does not meet the definition of major bleeding, but requires medical intervention or unscheduled contact with the physician, (temporary) discontinuation of the study treatment, discomfort to the subject such as pain, or impairment of activities of daily life.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=639 Participants
Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
|
Warfarin
n=639 Participants
Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
|
|---|---|---|
|
Event Rate of the Composite Endpoint of Adjudicated Major Bleeding or Adjudicated Non-major Clinically Relevant Bleeding
|
18.04 Events per 100 patient-years
|
16.42 Events per 100 patient-years
|
SECONDARY outcome
Timeframe: Up to 2 days after the last dosePopulation: The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).
This is the principal efficacy endpoint. Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were "non-CNS systemic embolism": peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=637 Participants
Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
|
Warfarin
n=637 Participants
Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
|
|---|---|---|
|
Event Rate of the Composite Endpoint of Adjudicated Stroke and Non-central Nervous System (CNS) Systemic Embolism
|
1.26 Events per 100 patient-years
|
2.61 Events per 100 patient-years
|
SECONDARY outcome
Timeframe: Up to 2 days after the last dosePopulation: The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).
Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were "non-CNS systemic embolism": peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded. Any death that was not clearly non-vascular.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=637 Participants
Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
|
Warfarin
n=637 Participants
Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
|
|---|---|---|
|
Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, and Vascular Death
|
1.83 Events per 100 patient-years
|
2.85 Events per 100 patient-years
|
SECONDARY outcome
Timeframe: Up to 2 days after the last dosePopulation: The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).
Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were "non-CNS systemic embolism": peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded. Myocardial infarction: assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for ≥2 leads, or autopsy confirmation. Any death that was not clearly non-vascular.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=637 Participants
Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
|
Warfarin
n=637 Participants
Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
|
|---|---|---|
|
Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, Myocardial Infarction, and Vascular Death
|
2.18 Events per 100 patient-years
|
2.97 Events per 100 patient-years
|
SECONDARY outcome
Timeframe: Up to 2 days after the last dosePopulation: The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).
All events were adjudicated and confirmed by a central independent committee blinded to treatment. Stroke included hemorrhagic (Stroke with local collections of intraparenchymal blood. Subarachnoid hemorrhage, subdural hemorrhage, and epidural hemorrhage were excluded.), ischemic infarction (Stroke without focal collection of intracranial blood) and unknown (No imaging data and anatomic findings were available.).
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=637 Participants
Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
|
Warfarin
n=637 Participants
Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
|
|---|---|---|
|
Event Rate of Stroke
|
1.15 Events per 100 patient-years
|
2.49 Events per 100 patient-years
|
SECONDARY outcome
Timeframe: Up to 2 days after the last dosePopulation: The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).
All events were adjudicated and confirmed by a central independent committee blinded to treatment. Non-CNS systemic embolism was abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms (such as trauma, atherosclerosis, and instrumentation). Arterial emboli in the following areas were "non-CNS systemic embolism": peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded from this category.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=637 Participants
Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
|
Warfarin
n=637 Participants
Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
|
|---|---|---|
|
Event Rate of Non-CNS Systemic Embolism
|
0.11 Events per 100 patient-years
|
0.12 Events per 100 patient-years
|
SECONDARY outcome
Timeframe: Up to 2 days after the last dosePopulation: The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).
All events were adjudicated and confirmed by a central independent committee blinded to treatment. Myocardial infarction was assessed based on either cardiac bio-markers (troponin I, troponin T, or creatine kinase-muscle and brain subunit isozyme), new abnormal Q waves appeared on ECG for 2 or more leads, or autopsy confirmation.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=637 Participants
Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
|
Warfarin
n=637 Participants
Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
|
|---|---|---|
|
Event Rate of Myocardial Infarction
|
0.34 Events per 100 patient-years
|
0.12 Events per 100 patient-years
|
SECONDARY outcome
Timeframe: Up to 2 days after the last dosePopulation: The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).
All events were adjudicated and confirmed by a central independent committee blinded to treatment. Any death that was not clearly non-vascular (e.g., deaths due to spontaneous bleeding, myocardial infarction, stroke, cardiac failure, and arrhythmia)
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=637 Participants
Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
|
Warfarin
n=637 Participants
Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
|
|---|---|---|
|
Event Rate of Vascular Death
|
0.69 Events per 100 patient-years
|
0.24 Events per 100 patient-years
|
SECONDARY outcome
Timeframe: Up to 2 days after the last dosePopulation: The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).
All events were adjudicated and confirmed by a central independent committee blinded to treatment. A stroke was considered disabling if the participant's modified Rankin score was between 3 and 5, inclusive.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=637 Participants
Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
|
Warfarin
n=637 Participants
Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
|
|---|---|---|
|
Event Rate of Stroke With Serious Residual Disability
|
0.57 Events per 100 patient-years
|
1.19 Events per 100 patient-years
|
SECONDARY outcome
Timeframe: Up to 2 days after the last dosePopulation: The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).
All events were adjudicated and confirmed by a central independent committee blinded to treatment. All-cause death included vascular death and non-vascular death.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=637 Participants
Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
|
Warfarin
n=637 Participants
Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
|
|---|---|---|
|
Event Rate of All-cause Death
|
0.80 Events per 100 patient-years
|
0.59 Events per 100 patient-years
|
SECONDARY outcome
Timeframe: Up to 2 days after the last dosePopulation: The safety analysis population consisted of randomized participants who took at least one dose of study treatment (639 in each treatment group).
All events were adjudicated and confirmed by a central independent committee blinded to treatment. Major bleeding was clinically overt bleeding associated with a fall in hemoglobin of 2 g/dL or higher, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=639 Participants
Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
|
Warfarin
n=639 Participants
Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
|
|---|---|---|
|
Event Rate of Adjudicated Major Bleeding
|
3.00 Events per 100 patient-years
|
3.59 Events per 100 patient-years
|
SECONDARY outcome
Timeframe: Up to 2 days after the last dosePopulation: The safety analysis population consisted of randomized participants who took at least one dose of study treatment (639 in each treatment group).
All events were adjudicated and confirmed by a central independent committee blinded to treatment. Non-major clinically relevant bleeding was clinically overt bleeding that does not meet the definition of major bleeding, but requires medical intervention or unscheduled contact with the physician, (temporary) discontinuation of the study treatment, discomfort to the subject such as pain, or impairment of activities of daily life.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=639 Participants
Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
|
Warfarin
n=639 Participants
Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
|
|---|---|---|
|
Event Rate Adjudicated Non-major Clinically Relevant Bleeding
|
15.42 Events per 100 patient-years
|
12.99 Events per 100 patient-years
|
Adverse Events
RG1: Rivaroxaban Double-blind (DB) Period
Serious events: 151 serious events
Other events: 474 other events
Deaths: 0 deaths
RG2: Warfarin DB Period
Serious events: 155 serious events
Other events: 470 other events
Deaths: 0 deaths
RG3: Rivaroxaban Follow-up (FU) Period
Serious events: 50 serious events
Other events: 73 other events
Deaths: 0 deaths
RG4: Warfarin FU Period
Serious events: 37 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RG1: Rivaroxaban Double-blind (DB) Period
n=639 participants at risk
Participants orally administered a rivaroxaban 15 mg tablet (a 10 mg tablet for participants with creatinine clearance of 30 to 49 mL/min, inclusive, at screening) and a warfarin placebo tablet once daily (OD) during the double-blind treatment period. Safety data collected start with the first dose of study drug up to 2 days after the last dose
|
RG2: Warfarin DB Period
n=639 participants at risk
Participants orally administered a warfarin potassium tablet and a rivaroxaban placebo tablet OD during the double-blind treatment period. Safety data collected start with the first dose of study drug up to 2 days after the last dose
|
RG3: Rivaroxaban Follow-up (FU) Period
n=628 participants at risk
Participants orally administered a rivaroxaban 15 mg tablet (a 10 mg tablet for participants with creatinine clearance of 30 to 49 mL/min, inclusive, at screening) and a warfarin placebo tablet once daily (OD) during the double-blind treatment period. Safety data collected from last dose plus 2 days to end of trial
|
RG4: Warfarin FU Period
n=630 participants at risk
Participants orally administered a warfarin potassium tablet and a rivaroxaban placebo tablet OD during the double-blind treatment period. Safety data collected from last dose plus 2 days to end of trial
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.63%
4/639 • Number of events 4 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.47%
3/639 • Number of events 3 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.32%
2/628 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.32%
2/628 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Blood and lymphatic system disorders
Hypoprothrombinaemia
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.32%
2/628 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Cardiac disorders
Angina pectoris
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.31%
2/639 • Number of events 3 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Cardiac disorders
Angina unstable
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.32%
2/628 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Cardiac disorders
Atrial fibrillation
|
0.63%
4/639 • Number of events 5 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Cardiac disorders
Atrial flutter
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Cardiac disorders
Cardiac failure
|
1.9%
12/639 • Number of events 12 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
1.7%
11/639 • Number of events 18 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.48%
3/628 • Number of events 3 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.63%
4/630 • Number of events 4 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 3 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.47%
3/639 • Number of events 3 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.47%
3/639 • Number of events 3 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.47%
3/639 • Number of events 3 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.32%
2/630 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Ear and labyrinth disorders
Vertigo
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Ear and labyrinth disorders
Auditory meatus external erosion
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Eye disorders
Cataract
|
1.4%
9/639 • Number of events 10 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
1.1%
7/639 • Number of events 8 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Eye disorders
Glaucoma
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Eye disorders
Retinal detachment
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Eye disorders
Retinal haemorrhage
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Eye disorders
Macular hole
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Anal polyp
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.78%
5/639 • Number of events 5 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
1.4%
9/639 • Number of events 12 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Dental caries
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.47%
3/639 • Number of events 3 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.47%
3/639 • Number of events 3 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.63%
4/639 • Number of events 4 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Melaena
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Nausea
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Periodontitis
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.47%
3/639 • Number of events 4 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Subileus
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
General disorders
Malaise
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
General disorders
Oedema
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
General disorders
Oedema peripheral
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
General disorders
Pyrexia
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
General disorders
Sudden death
|
0.63%
4/639 • Number of events 4 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.48%
3/628 • Number of events 3 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
General disorders
Sudden cardiac death
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Immune system disorders
Anaphylactic reaction
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Infections and infestations
Appendicitis
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Infections and infestations
Bronchitis
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Infections and infestations
Cellulitis
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Infections and infestations
Gastroenteritis
|
0.47%
3/639 • Number of events 3 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Infections and infestations
Gastroenteritis viral
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Infections and infestations
Herpes zoster
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Infections and infestations
Meningitis bacterial
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Infections and infestations
Otitis media
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Infections and infestations
Pneumonia
|
2.2%
14/639 • Number of events 15 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
1.6%
10/639 • Number of events 11 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.48%
3/628 • Number of events 3 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.48%
3/630 • Number of events 3 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Infections and infestations
Sepsis
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.32%
2/628 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Infections and infestations
Urinary tract infection
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Infections and infestations
Anal abscess
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Infections and infestations
Lung infection
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Infections and infestations
Enterocolitis viral
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Infections and infestations
Infective spondylitis
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Accidental exposure
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.63%
4/639 • Number of events 6 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Spinal cord injury cervical
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Investigations
Blood pressure decreased
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.48%
3/628 • Number of events 3 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.63%
4/639 • Number of events 6 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.16%
1/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.63%
4/639 • Number of events 4 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.32%
2/628 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.32%
2/630 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to neck
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal sinus cancer
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.32%
2/628 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.47%
3/639 • Number of events 3 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Cholinergic syndrome
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.47%
3/639 • Number of events 4 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Dizziness
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Epilepsy
|
0.63%
4/639 • Number of events 5 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Facial palsy
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.32%
2/628 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Syncope
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.32%
2/630 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Vertebral artery stenosis
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Putamen haemorrhage
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Ischaemic stroke
|
1.4%
9/639 • Number of events 9 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
2.8%
18/639 • Number of events 18 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
1.6%
10/628 • Number of events 12 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.63%
4/630 • Number of events 4 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Postresuscitation encephalopathy
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Psychiatric disorders
Psychosomatic disease
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Renal and urinary disorders
Haematuria
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.16%
1/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Renal and urinary disorders
Renal failure acute
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Renal and urinary disorders
Renal impairment
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Renal and urinary disorders
Renal embolism
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.47%
3/639 • Number of events 3 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 5 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.47%
3/639 • Number of events 3 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Vascular disorders
Aortic aneurysm
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Vascular disorders
Aortic dissection
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Vascular disorders
Haematoma
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Vascular disorders
Shock haemorrhagic
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/639 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.00%
0/639 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.31%
2/639 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
Other adverse events
| Measure |
RG1: Rivaroxaban Double-blind (DB) Period
n=639 participants at risk
Participants orally administered a rivaroxaban 15 mg tablet (a 10 mg tablet for participants with creatinine clearance of 30 to 49 mL/min, inclusive, at screening) and a warfarin placebo tablet once daily (OD) during the double-blind treatment period. Safety data collected start with the first dose of study drug up to 2 days after the last dose
|
RG2: Warfarin DB Period
n=639 participants at risk
Participants orally administered a warfarin potassium tablet and a rivaroxaban placebo tablet OD during the double-blind treatment period. Safety data collected start with the first dose of study drug up to 2 days after the last dose
|
RG3: Rivaroxaban Follow-up (FU) Period
n=628 participants at risk
Participants orally administered a rivaroxaban 15 mg tablet (a 10 mg tablet for participants with creatinine clearance of 30 to 49 mL/min, inclusive, at screening) and a warfarin placebo tablet once daily (OD) during the double-blind treatment period. Safety data collected from last dose plus 2 days to end of trial
|
RG4: Warfarin FU Period
n=630 participants at risk
Participants orally administered a warfarin potassium tablet and a rivaroxaban placebo tablet OD during the double-blind treatment period. Safety data collected from last dose plus 2 days to end of trial
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
5.6%
36/639 • Number of events 39 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
4.5%
29/639 • Number of events 35 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.80%
5/628 • Number of events 6 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.32%
2/630 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Eye disorders
Conjunctival haemorrhage
|
4.1%
26/639 • Number of events 32 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
6.6%
42/639 • Number of events 57 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
1.4%
9/628 • Number of events 9 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Constipation
|
5.9%
38/639 • Number of events 46 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
5.0%
32/639 • Number of events 40 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
1.9%
12/628 • Number of events 12 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
1.3%
8/630 • Number of events 8 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Dental caries
|
4.4%
28/639 • Number of events 32 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
5.3%
34/639 • Number of events 35 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/630 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.9%
57/639 • Number of events 71 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
6.3%
40/639 • Number of events 47 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.48%
3/628 • Number of events 3 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.95%
6/630 • Number of events 6 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Gastrointestinal disorders
Gingival bleeding
|
8.5%
54/639 • Number of events 72 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
4.9%
31/639 • Number of events 38 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.32%
2/630 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Infections and infestations
Nasopharyngitis
|
32.2%
206/639 • Number of events 378 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
36.3%
232/639 • Number of events 412 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
2.5%
16/628 • Number of events 16 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
2.4%
15/630 • Number of events 16 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Contusion
|
9.1%
58/639 • Number of events 82 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
8.8%
56/639 • Number of events 80 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.64%
4/628 • Number of events 4 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.63%
4/630 • Number of events 4 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
5.2%
33/639 • Number of events 38 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
4.2%
27/639 • Number of events 31 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/628 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
6.7%
43/639 • Number of events 48 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
4.9%
31/639 • Number of events 34 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.00%
0/628 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.8%
50/639 • Number of events 57 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
8.8%
56/639 • Number of events 60 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.80%
5/628 • Number of events 5 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
1.1%
7/630 • Number of events 7 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Nervous system disorders
Headache
|
3.8%
24/639 • Number of events 29 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
6.1%
39/639 • Number of events 43 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.96%
6/628 • Number of events 6 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.32%
2/630 • Number of events 3 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.0%
102/639 • Number of events 203 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
9.2%
59/639 • Number of events 86 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.96%
6/628 • Number of events 8 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
1.3%
8/630 • Number of events 8 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
8.6%
55/639 • Number of events 76 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
11.6%
74/639 • Number of events 102 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.48%
3/628 • Number of events 3 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.8%
37/639 • Number of events 50 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
6.7%
43/639 • Number of events 49 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.32%
2/628 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.16%
1/630 • Number of events 1 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
10.5%
67/639 • Number of events 147 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
12.4%
79/639 • Number of events 175 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
1.4%
9/628 • Number of events 9 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.95%
6/630 • Number of events 7 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
|
Vascular disorders
Hypertension
|
3.8%
24/639 • Number of events 25 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
5.0%
32/639 • Number of events 36 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.48%
3/628 • Number of events 3 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
0.32%
2/630 • Number of events 2 • Reporting Group (RG) 1 + 2: Safety data collected start with the first dose of study drug up to 2 days after the last dose; Reporting Group (RG) 3 + 4: Safety data collected from last dose plus 2 days to end of trial.
RG3: During follow-up period, participants could be transitioned from study drug to an open-label warfarin or other appropriate therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60