Pulmonary Embolism, Thromboembolism, Thrombosis, Venous Thromboembolism, Venous Thrombosis
Conditions
Keywords
deep vein thrombosis, pulmonary embolism, long-term prevention of recurrent symptomatic VTE
Brief summary
This is a multicenter, randomized, double-blind, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial
Interventions
DRUGBAY 59-7939
10 mg tablet once daily for 12 months
DRUGASA
100 mg tablet once daily for 12 months
Sponsors
Janssen Scientific Affairs, LLC
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with confirmed symptomatic PE and/or DVT who have been treated for 6 to 12 months and did not interrupt anticoagulation for longer than 1 week
Exclusion criteria
* Legal lower age limitations (country specific) Indication for therapeutic-dosed anticoagulants Indication for antiplatelet therapy or a conventional non-steroid anti-inflammatory drug (NSAID) Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk Calculated creatinine clearance \< 30 mL/min
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism | Up to 12 months, at least 6 months | The primary efficacy outcomes (i.e., recurrent venous thromboembolism \[VTE\] defined as composite of fatal or non-fatal symptomatic recurrent VTE, including unexplained death for which pulmonary embolism \[PE\] could not be ruled out) as confirmed by the central independent adjudication committee (CIAC) were considered up to the end of the individual intended duration of treatment. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant. |
| Number of Participants With First Treatment-emergent Major Bleeding | Up to 12 months, at least 6 months | The principal safety outcome was major bleeding which was defined according to the criteria of the International Society on Thrombosis and Hemostasis (ISTH) as clinically overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra articular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Up to 12 months, at least 6 months | The secondary efficacy outcome is the composite of the primary efficacy outcome, myocardial infarction (MI), ischemic stroke or non-central nervous system (CNS) systemic embolism. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant. |
| Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days | Up to 12 months, at least 6 months | The secondary safety outcome was clinically relevant non-major (CRNM) bleeding, which was adjudicated by the CIAC using the ASA criteria: the bleeding was non-major and the bleeding was associated with a study medication interruption of more than 14 days. |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States, Vietnam
Participant flow
Recruitment details
In total 3439 participants were screened at 244 sites in 31 countries from 05-Mar-2014 (First Patient First Visit) to 15-Mar-2016 (Last Patient First Visit).
Pre-assignment details
Of the 3439 participants screened 43 did not complete screening. Thus, 3396 participants were randomly assigned to treatment, 31 of the randomized participants never received study medication because either withdrew consent or were withdrawn from the study based on protocol violations.
Participants by arm
| Arm | Count |
|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. | 1,127 |
| Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. | 1,107 |
| Acetylsalicylic (ASA) 100 mg, OD Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. | 1,131 |
| Total | 3,365 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 51 | 47 | 46 |
| Overall Study | Death | 0 | 2 | 3 |
| Overall Study | Efficacy outcome reached | 18 | 16 | 57 |
| Overall Study | Logistical difficulties | 6 | 5 | 2 |
| Overall Study | Lost to Follow-up | 1 | 3 | 4 |
| Overall Study | Non-compliance with study medication | 21 | 19 | 23 |
| Overall Study | Other | 2 | 2 | 7 |
| Overall Study | Physician Decision | 0 | 1 | 1 |
| Overall Study | Protocol Violation | 3 | 5 | 3 |
| Overall Study | Safety outcome reached | 12 | 20 | 10 |
| Overall Study | Withdrawal by Subject | 29 | 18 | 26 |
Baseline characteristics
| Characteristic | Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Acetylsalicylic (ASA) 100 mg, OD | Total |
|---|---|---|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 14.7 | 57.9 years STANDARD_DEVIATION 14.7 | 58.8 years STANDARD_DEVIATION 14.7 | 58.5 years STANDARD_DEVIATION 14.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants | 31 Participants | 30 Participants | 92 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 892 Participants | 899 Participants | 889 Participants | 2680 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 204 Participants | 177 Participants | 212 Participants | 593 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 161 Participants | 159 Participants | 159 Participants | 479 Participants |
| Race (NIH/OMB) Black or African American | 41 Participants | 49 Participants | 36 Participants | 126 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 135 Participants | 126 Participants | 141 Participants | 402 Participants |
| Race (NIH/OMB) White | 786 Participants | 772 Participants | 786 Participants | 2344 Participants |
| Sex: Female, Male Female | 507 Participants | 505 Participants | 488 Participants | 1500 Participants |
| Sex: Female, Male Male | 620 Participants | 602 Participants | 643 Participants | 1865 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 40 / 1,127 | 35 / 1,107 | 38 / 1,131 |
| serious Total, serious adverse events | 78 / 1,127 | 82 / 1,107 | 79 / 1,131 |
Outcome results
Primary
Number of Participants With First Treatment-emergent Major Bleeding
The principal safety outcome was major bleeding which was defined according to the criteria of the International Society on Thrombosis and Hemostasis (ISTH) as clinically overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra articular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
Time frame: Up to 12 months, at least 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Number of Participants With First Treatment-emergent Major Bleeding | Any major bleeding | 5 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Number of Participants With First Treatment-emergent Major Bleeding | Fatal bleeding | 0 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Number of Participants With First Treatment-emergent Major Bleeding | Non-fatal critical organ bleed | 2 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Number of Participants With First Treatment-emergent Major Bleeding | Non-fatal non-critical organ bleeding | 3 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Number of Participants With First Treatment-emergent Major Bleeding | Non-fatal non-critical organ bleeding | 1 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Number of Participants With First Treatment-emergent Major Bleeding | Any major bleeding | 6 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Number of Participants With First Treatment-emergent Major Bleeding | Non-fatal critical organ bleed | 4 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Number of Participants With First Treatment-emergent Major Bleeding | Fatal bleeding | 1 participants |
| Acetylsalicylic (ASA) 100 mg, OD | Number of Participants With First Treatment-emergent Major Bleeding | Non-fatal non-critical organ bleeding | 1 participants |
| Acetylsalicylic (ASA) 100 mg, OD | Number of Participants With First Treatment-emergent Major Bleeding | Fatal bleeding | 1 participants |
| Acetylsalicylic (ASA) 100 mg, OD | Number of Participants With First Treatment-emergent Major Bleeding | Non-fatal critical organ bleed | 1 participants |
| Acetylsalicylic (ASA) 100 mg, OD | Number of Participants With First Treatment-emergent Major Bleeding | Any major bleeding | 3 participants |
Comparison: Statistical analysis was performed on the first occurrence of the composite outcome.p-value: 0.323595% CI: [0.5, 8.04]Wald test
Comparison: Statistical analysis was performed on the first occurrence of the composite outcome.p-value: 0.500595% CI: [0.39, 6.84]Wald test
Comparison: Statistical analysis was performed on the first occurrence of the composite outcome.p-value: 0.733795% CI: [0.37, 4.03]Wald test
Primary
Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism
The primary efficacy outcomes (i.e., recurrent venous thromboembolism \[VTE\] defined as composite of fatal or non-fatal symptomatic recurrent VTE, including unexplained death for which pulmonary embolism \[PE\] could not be ruled out) as confirmed by the central independent adjudication committee (CIAC) were considered up to the end of the individual intended duration of treatment. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
Time frame: Up to 12 months, at least 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism | Death (PE) | 0 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism | Symptomatic recurrent PE | 5 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism | Composite | 13 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism | Symptomatic recurrent Deep vein thrombosis (DVT) | 8 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism | Death (unexplained and PE cannot be ruled out) | 0 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism | Symptomatic recurrent PE | 6 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism | Composite | 17 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism | Symptomatic recurrent Deep vein thrombosis (DVT) | 9 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism | Death (PE) | 0 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism | Death (unexplained and PE cannot be ruled out) | 2 participants |
| Acetylsalicylic (ASA) 100 mg, OD | Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism | Death (unexplained and PE cannot be ruled out) | 1 participants |
| Acetylsalicylic (ASA) 100 mg, OD | Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism | Death (PE) | 1 participants |
| Acetylsalicylic (ASA) 100 mg, OD | Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism | Composite | 50 participants |
| Acetylsalicylic (ASA) 100 mg, OD | Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism | Symptomatic recurrent PE | 19 participants |
| Acetylsalicylic (ASA) 100 mg, OD | Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism | Symptomatic recurrent Deep vein thrombosis (DVT) | 29 participants |
Comparison: Statistical analysis was performed on the first occurrence of the composite outcome.p-value: 0.000195% CI: [0.2, 0.59]Wald test
Comparison: Statistical analysis was performed on the first occurrence of the composite outcome.p-value: <0.000198% CI: [0.14, 0.47]Wald test
Comparison: Statistical analysis was performed on the first occurrence of the composite outcome.p-value: 0.432895% CI: [0.65, 2.75]Wald test
Secondary
Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days
The secondary safety outcome was clinically relevant non-major (CRNM) bleeding, which was adjudicated by the CIAC using the ASA criteria: the bleeding was non-major and the bleeding was associated with a study medication interruption of more than 14 days.
Time frame: Up to 12 months, at least 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days | 12 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days | 17 participants |
| Acetylsalicylic (ASA) 100 mg, OD | Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days | 12 participants |
p-value: 0.331895% CI: [0.69, 3.02]Wald test
p-value: 0.972695% CI: [0.44, 2.2]Wald test
p-value: 0.313795% CI: [0.7, 3.06]Wald test
Secondary
Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism
The secondary efficacy outcome is the composite of the primary efficacy outcome, myocardial infarction (MI), ischemic stroke or non-central nervous system (CNS) systemic embolism. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
Time frame: Up to 12 months, at least 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Composite | 18 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Ischemic stroke | 4 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Non-CNS systemic embolism | 1 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Myocardial infarction | 0 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Symptomatic recurrent DVT | 8 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Symptomatic recurrent PE | 5 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Death (PE) | 0 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Death (unexplained and PE cannot be ruled out) | 0 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Death (cardiovascular: myocardial infarction) | 0 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Death (cardiovascular: ischemic stroke) | 0 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Death (cardiovascular: myocardial infarction) | 0 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Composite | 19 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Symptomatic recurrent PE | 6 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Symptomatic recurrent DVT | 9 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Ischemic stroke | 2 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Death (cardiovascular: ischemic stroke) | 0 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Death (unexplained and PE cannot be ruled out) | 1 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Non-CNS systemic embolism | 0 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Death (PE) | 0 participants |
| Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Myocardial infarction | 1 participants |
| Acetylsalicylic (ASA) 100 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Death (unexplained and PE cannot be ruled out) | 1 participants |
| Acetylsalicylic (ASA) 100 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Myocardial infarction | 4 participants |
| Acetylsalicylic (ASA) 100 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Symptomatic recurrent DVT | 29 participants |
| Acetylsalicylic (ASA) 100 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Symptomatic recurrent PE | 18 participants |
| Acetylsalicylic (ASA) 100 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Death (cardiovascular: myocardial infarction) | 0 participants |
| Acetylsalicylic (ASA) 100 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Death (PE) | 1 participants |
| Acetylsalicylic (ASA) 100 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Composite | 56 participants |
| Acetylsalicylic (ASA) 100 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Death (cardiovascular: ischemic stroke) | 0 participants |
| Acetylsalicylic (ASA) 100 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Ischemic stroke | 2 participants |
| Acetylsalicylic (ASA) 100 mg, OD | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism | Non-CNS systemic embolism | 1 participants |
Comparison: Statistical analysis was performed on the first occurrence of the composite outcome.p-value: <0.000195% CI: [0.2, 0.57]Wald test
Comparison: Statistical analysis was performed on the first occurrence of the composite outcome.p-value: <0.000195% CI: [0.19, 0.54]Wald test
Comparison: Statistical analysis was performed on the first occurrence of the composite outcome.p-value: 0.817295% CI: [0.57, 2.06]Wald test