Trial Outcomes & Findings for Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis - The EINSTEIN DVT Study (NCT NCT00440193)
NCT ID: NCT00440193
Last Updated: 2014-02-27
Results Overview
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.
COMPLETED
PHASE3
3449 participants
3-, 6- or 12-month study treatment period
2014-02-27
Participant Flow
Participants with confirmed acute proximal symptomatic deep vein thrombosis (DVT) without symptomatic pulmonary embolism (PE) were recruited at specialized study sites.
Out of 3459 participants screened, 10 failed screening due to protocol violations, and 3449 participants were randomized (1731 to rivaroxaban and 1718 to enoxaparin/VKA).
Participant milestones
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
|
Enoxaparin/VKA
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
|
|---|---|---|
|
Treatment Period
STARTED
|
1731
|
1718
|
|
Treatment Period
Participants Received Treatment
|
1718
|
1711
|
|
Treatment Period
COMPLETED
|
1426
|
1367
|
|
Treatment Period
NOT COMPLETED
|
305
|
351
|
|
Observational Period
STARTED
|
1425
|
1407
|
|
Observational Period
COMPLETED
|
1380
|
1369
|
|
Observational Period
NOT COMPLETED
|
45
|
38
|
Reasons for withdrawal
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
|
Enoxaparin/VKA
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
|
|---|---|---|
|
Treatment Period
Adverse Event
|
74
|
67
|
|
Treatment Period
Death
|
19
|
22
|
|
Treatment Period
Lack of Efficacy
|
0
|
1
|
|
Treatment Period
Lost to Follow-up
|
12
|
18
|
|
Treatment Period
Physician Decision
|
3
|
6
|
|
Treatment Period
Protocol Violation
|
16
|
19
|
|
Treatment Period
Withdrawal by Subject
|
36
|
77
|
|
Treatment Period
Clinical endpoint reached
|
28
|
25
|
|
Treatment Period
Study terminated by sponsor
|
102
|
94
|
|
Treatment Period
Protocol driven decision point
|
2
|
2
|
|
Treatment Period
Switch to commercial drug
|
0
|
2
|
|
Treatment Period
Technical problems
|
1
|
1
|
|
Treatment Period
Participant convenience
|
5
|
2
|
|
Treatment Period
Participant did not receive treatment
|
7
|
13
|
|
Treatment Period
Site closed by investigator
|
0
|
2
|
|
Observational Period
Adverse Event
|
2
|
2
|
|
Observational Period
Death
|
15
|
20
|
|
Observational Period
Lost to Follow-up
|
12
|
8
|
|
Observational Period
Protocol Violation
|
1
|
0
|
|
Observational Period
Withdrawal by Subject
|
11
|
8
|
|
Observational Period
Physician Decision
|
1
|
0
|
|
Observational Period
Clinical endpoint reached
|
1
|
0
|
|
Observational Period
Participant convenience
|
2
|
0
|
Baseline Characteristics
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis - The EINSTEIN DVT Study
Baseline characteristics by cohort
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=1731 Participants
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
|
Enoxaparin/VKA
n=1718 Participants
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
|
Total
n=3449 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.8 years
STANDARD_DEVIATION 16.4 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 16.3 • n=7 Participants
|
56.1 years
STANDARD_DEVIATION 16.4 • n=5 Participants
|
|
Age, Customized
18 - < 40 years
|
314 participants
n=5 Participants
|
279 participants
n=7 Participants
|
593 participants
n=5 Participants
|
|
Age, Customized
40 - < 60 years
|
642 participants
n=5 Participants
|
662 participants
n=7 Participants
|
1304 participants
n=5 Participants
|
|
Age, Customized
60 - < 75 years
|
530 participants
n=5 Participants
|
519 participants
n=7 Participants
|
1049 participants
n=5 Participants
|
|
Age, Customized
≥ 75 years
|
245 participants
n=5 Participants
|
258 participants
n=7 Participants
|
503 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
738 Participants
n=5 Participants
|
751 Participants
n=7 Participants
|
1489 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
993 Participants
n=5 Participants
|
967 Participants
n=7 Participants
|
1960 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3-, 6- or 12-month study treatment periodPopulation: The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=1731 Participants
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
|
Enoxaparin/VKA
n=1718 Participants
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
|
|---|---|---|
|
Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment
|
2.1 Percentage of participants
|
3.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 3-, 6- or 12-month study treatment periodPopulation: The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=1731 Participants
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
|
Enoxaparin/VKA
n=1718 Participants
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
|
|---|---|---|
|
Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment
|
4.0 Percentage of participants
|
5.1 Percentage of participants
|
SECONDARY outcome
Timeframe: 3-, 6- or 12-month study treatment periodPopulation: The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.
Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=1731 Participants
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
|
Enoxaparin/VKA
n=1718 Participants
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
|
|---|---|---|
|
Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment
|
2.9 Percentage of participants
|
4.2 Percentage of participants
|
SECONDARY outcome
Timeframe: 3-, 6- or 12-month study treatment periodPopulation: The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=1731 Participants
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
|
Enoxaparin/VKA
n=1718 Participants
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
|
|---|---|---|
|
Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment
|
0.9 Percentage of participants
|
1.6 Percentage of participants
|
SECONDARY outcome
Timeframe: 3-, 6- or 12-month study treatment periodPopulation: The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, 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) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=1718 Participants
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
|
Enoxaparin/VKA
n=1711 Participants
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
|
|---|---|---|
|
Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)
|
8.1 Percentage of participants
|
8.1 Percentage of participants
|
SECONDARY outcome
Timeframe: 3-, 6- or 12-month study treatment periodPopulation: The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=1718 Participants
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
|
Enoxaparin/VKA
n=1711 Participants
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
|
|---|---|---|
|
Percentage of Participants With All Deaths
All post-randomization
|
2.4 Percentage of participants
|
3.0 Percentage of participants
|
|
Percentage of Participants With All Deaths
Treatment-emergent (time window: 2 days)
|
1.0 Percentage of participants
|
1.1 Percentage of participants
|
|
Percentage of Participants With All Deaths
Treatment-emergent (time window: 7 days)
|
1.2 Percentage of participants
|
1.5 Percentage of participants
|
SECONDARY outcome
Timeframe: 3-, 6- or 12-month study treatment periodPopulation: The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.
All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=1718 Participants
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
|
Enoxaparin/VKA
n=1711 Participants
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
|
|---|---|---|
|
Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)
|
0.7 Percentage of participants
|
0.8 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-, 6- or 12-month study treatment periodPopulation: The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=1731 Participants
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
|
Enoxaparin/VKA
n=1718 Participants
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
|
|---|---|---|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment
Death (other)
|
1.8 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment
Death (PE)
|
0.06 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment
Death (PE cannot be excluded)
|
0.2 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment
Symptomatic PE and DVT
|
0.06 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment
Symptomatic recurrent PE only
|
1.2 Percentage of participants
|
1.0 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment
Symptomatic recurrent DVT only
|
0.8 Percentage of participants
|
1.6 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment
Death (bleeding)
|
0.06 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment
Death (cardiovascular)
|
0.1 Percentage of participants
|
0.2 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment
Major bleeding
|
0.9 Percentage of participants
|
1.3 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 30 days after the last intake of study medicationPopulation: Participants entering the observational period were participants for whom the investigator indicated on the eCRF (electronic case report form) that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), results/films/images of confirmatory testing, and/or case summaries.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=1425 Participants
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
|
Enoxaparin/VKA
n=1408 Participants
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
|
|---|---|---|
|
Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) During Observational Period
|
0.8 Percentage of participants
|
0.5 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 30 days after the last intake of study medicationPopulation: Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=1430 Participants
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
|
Enoxaparin/VKA
n=1413 Participants
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
|
|---|---|---|
|
Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period
|
2.2 Percentage of participants
|
1.8 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 30 days after the last intake of study medicationPopulation: Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.
Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE or major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=1425 Participants
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
|
Enoxaparin/VKA
n=1410 Participants
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
|
|---|---|---|
|
Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period
|
1.1 Percentage of participants
|
1.1 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 30 days after the last intake of study medicationPopulation: Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=1425 Participants
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
|
Enoxaparin/VKA
n=1408 Participants
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
|
|---|---|---|
|
Percentage of Participants With Recurrent DVT During Observational Period
|
0.6 Percentage of participants
|
0.3 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 30 days after the last intake of study medicationPopulation: Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=1425 Participants
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
|
Enoxaparin/VKA
n=1408 Participants
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
|
|---|---|---|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period
Death (PE)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period
Death (PE cannot be excluded)
|
0.07 Percentage of participants
|
0.07 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period
Symptomatic PE and DVT
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period
Symptomatic recurrent PE only
|
0.3 Percentage of participants
|
0.1 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period
Symptomatic recurrent DVT only
|
0.6 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period
Death (bleeding)
|
0.07 Percentage of participants
|
0.1 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period
Death (cardiovascular)
|
0.07 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period
Death (other)
|
1.3 Percentage of participants
|
0.8 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period
Major bleeding
|
0.2 Percentage of participants
|
0.6 Percentage of participants
|
POST_HOC outcome
Timeframe: 3-, 6- or 12-month study treatment periodPopulation: The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.
Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to transfusion of ≥2 units, occurring in a critical site or contributing to death, cardiovascular death, myocardial infarction, stroke, and non CNS (central nervous system) systemic embolism. Net clinical benefit was considered greater in those participants with fewer composite events. All events confirmed by independent committee blinded to treatment, based on compression ultrasound, venography, spiral CT scan, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy, results/films/images of confirmatory testing and/or case summaries
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=1731 Participants
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
|
Enoxaparin/VKA
n=1718 Participants
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
|
|---|---|---|
|
Percentage of Participants With an Event for Net Clinical Benefit 2 Until the Intended End of Study Treatment
|
3.6 Percentage of participants
|
4.7 Percentage of participants
|
POST_HOC outcome
Timeframe: Up to 30 days after the last intake of study medicationPopulation: Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.
Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding, cardiovascular death, myocardial infarctions, stroke, or non CNS systemic embolism. Major bleeding was associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound (DVT), venography (DVT), spiral CT scanning (PE), pulmonary angiography ( PE), ventilation/perfusion lung scan (PE), lung scintigraphy (PE), autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=1426 Participants
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
|
Enoxaparin/VKA
n=1410 Participants
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
|
|---|---|---|
|
Percentage of Participants With an Event for Net Clinical Benefit 2 During Observational Period
|
1.2 Percentage of participants
|
1.3 Percentage of participants
|
Adverse Events
Rivaroxaban (Xarelto, BAY59-7939)
Enoxaparin/VKA
Serious adverse events
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=1718 participants at risk
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
|
Enoxaparin/VKA
n=1711 participants at risk
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
|
|---|---|---|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.06%
1/1718
|
0.18%
3/1711
|
|
Blood and lymphatic system disorders
Anaemia
|
0.64%
11/1718
|
0.47%
8/1711
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Blood and lymphatic system disorders
Splenic haemorrhage
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.12%
2/1718
|
0.06%
1/1711
|
|
Blood and lymphatic system disorders
Autoimmune thrombocytopenia
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Cardiac disorders
Acute myocardial infarction
|
0.29%
5/1718
|
0.06%
1/1711
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Cardiac disorders
Angina unstable
|
0.06%
1/1718
|
0.18%
3/1711
|
|
Cardiac disorders
Arrhythmia
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Cardiac disorders
Atrial fibrillation
|
0.12%
2/1718
|
0.18%
3/1711
|
|
Cardiac disorders
Atrial flutter
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Cardiac disorders
Bradycardia
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/1718
|
0.18%
3/1711
|
|
Cardiac disorders
Cardiac failure
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/1718
|
0.12%
2/1711
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Cardiac disorders
Pericarditis
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Cardiac disorders
Right ventricular failure
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Cardiac disorders
Tachycardia
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Cardiac disorders
Tachyarrhythmia
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Cardiac disorders
Acute coronary syndrome
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Cardiac disorders
Cardiac disorder
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Ear and labyrinth disorders
Vertigo
|
0.12%
2/1718
|
0.06%
1/1711
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Endocrine disorders
Basedow's disease
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Endocrine disorders
Goitre
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Eye disorders
Blepharochalasis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/1718
|
0.12%
2/1711
|
|
Eye disorders
Eye haemorrhage
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Eye disorders
Hyphaema
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Eye disorders
Maculopathy
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Eye disorders
Retinal detachment
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Eye disorders
Vitreous detachment
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Abdominal pain
|
0.17%
3/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Gastrointestinal disorders
Ascites
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/1718
|
0.12%
2/1711
|
|
Gastrointestinal disorders
Constipation
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/1718
|
0.23%
4/1711
|
|
Gastrointestinal disorders
Diarrhoea
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/1718
|
0.12%
2/1711
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Gastritis
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.23%
4/1718
|
0.00%
0/1711
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Haematemesis
|
0.06%
1/1718
|
0.18%
3/1711
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/1718
|
0.12%
2/1711
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Intestinal dilatation
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.12%
2/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Melaena
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Nausea
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Pancreatitis
|
0.06%
1/1718
|
0.12%
2/1711
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.29%
5/1718
|
0.23%
4/1711
|
|
Gastrointestinal disorders
Rectal polyp
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Retroperitoneal fibrosis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/1718
|
0.12%
2/1711
|
|
Gastrointestinal disorders
Vomiting
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.12%
2/1718
|
0.00%
0/1711
|
|
Gastrointestinal disorders
Abdominal wall cyst
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Gastrointestinal disorders
Hernial eventration
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Intestinal mass
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/1718
|
0.06%
1/1711
|
|
General disorders
Chest pain
|
0.17%
3/1718
|
0.06%
1/1711
|
|
General disorders
Death
|
0.12%
2/1718
|
0.06%
1/1711
|
|
General disorders
Generalised oedema
|
0.06%
1/1718
|
0.00%
0/1711
|
|
General disorders
Impaired healing
|
0.00%
0/1718
|
0.06%
1/1711
|
|
General disorders
Malaise
|
0.06%
1/1718
|
0.06%
1/1711
|
|
General disorders
Multi-organ failure
|
0.17%
3/1718
|
0.12%
2/1711
|
|
General disorders
Oedema peripheral
|
0.17%
3/1718
|
0.00%
0/1711
|
|
General disorders
Pelvic mass
|
0.00%
0/1718
|
0.06%
1/1711
|
|
General disorders
Pyrexia
|
0.17%
3/1718
|
0.12%
2/1711
|
|
General disorders
Sudden death
|
0.00%
0/1718
|
0.06%
1/1711
|
|
General disorders
Sudden cardiac death
|
0.06%
1/1718
|
0.00%
0/1711
|
|
General disorders
General physical health deterioration
|
0.00%
0/1718
|
0.06%
1/1711
|
|
General disorders
Systemic inflammatory response syndrome
|
0.06%
1/1718
|
0.00%
0/1711
|
|
General disorders
Medical device complication
|
0.00%
0/1718
|
0.06%
1/1711
|
|
General disorders
Device occlusion
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Hepatobiliary disorders
Cholangitis
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/1718
|
0.12%
2/1711
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Hepatobiliary disorders
Hepatic mass
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Immune system disorders
Liver transplant rejection
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Infections and infestations
Abscess
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Infections and infestations
Appendicitis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Infections and infestations
Bacteraemia
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Infections and infestations
Bronchitis
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Infections and infestations
Bronchopneumonia
|
0.17%
3/1718
|
0.06%
1/1711
|
|
Infections and infestations
Cellulitis
|
0.17%
3/1718
|
0.23%
4/1711
|
|
Infections and infestations
Dengue fever
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Infections and infestations
Diverticulitis
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Infections and infestations
Erysipelas
|
0.00%
0/1718
|
0.12%
2/1711
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1718
|
0.23%
4/1711
|
|
Infections and infestations
Influenza
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Infections and infestations
Lobar pneumonia
|
0.06%
1/1718
|
0.18%
3/1711
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Infections and infestations
Mastitis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Infections and infestations
Paronychia
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Infections and infestations
Pneumonia
|
0.29%
5/1718
|
0.58%
10/1711
|
|
Infections and infestations
Postoperative wound infection
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Infections and infestations
Pyelonephritis
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Infections and infestations
Sepsis
|
0.12%
2/1718
|
0.41%
7/1711
|
|
Infections and infestations
Septic shock
|
0.06%
1/1718
|
0.23%
4/1711
|
|
Infections and infestations
Tracheobronchitis
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Infections and infestations
Urinary tract infection
|
0.29%
5/1718
|
0.18%
3/1711
|
|
Infections and infestations
Viral infection
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Infections and infestations
Anal abscess
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Infections and infestations
Incision site abscess
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Infections and infestations
Abscess limb
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Infections and infestations
Cardiac valve vegetation
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Infections and infestations
Cerebral toxoplasmosis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Infections and infestations
Infective aneurysm
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Infections and infestations
Wound abscess
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/1718
|
0.12%
2/1711
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/1718
|
0.12%
2/1711
|
|
Infections and infestations
Lung infection
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Infections and infestations
Respiratory tract infection
|
0.06%
1/1718
|
0.12%
2/1711
|
|
Infections and infestations
Device related infection
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Infections and infestations
Incision site infection
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Infections and infestations
Post procedural sepsis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/1718
|
0.12%
2/1711
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.12%
2/1718
|
0.00%
0/1711
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Injury, poisoning and procedural complications
Overdose
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/1718
|
0.12%
2/1711
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Injury, poisoning and procedural complications
Contusion
|
0.12%
2/1718
|
0.06%
1/1711
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.06%
1/1718
|
0.12%
2/1711
|
|
Injury, poisoning and procedural complications
Induced abortion haemorrhage
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Injury, poisoning and procedural complications
Gastrointestinal disorder postoperative
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Investigations
Alanine aminotransferase increased
|
0.12%
2/1718
|
0.35%
6/1711
|
|
Investigations
Blood bilirubin increased
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Investigations
Chest X-ray abnormal
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Investigations
International normalised ratio increased
|
0.00%
0/1718
|
0.29%
5/1711
|
|
Investigations
Liver function test abnormal
|
0.12%
2/1718
|
0.23%
4/1711
|
|
Investigations
Weight decreased
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Investigations
Transaminases increased
|
0.12%
2/1718
|
0.00%
0/1711
|
|
Investigations
Hepatic enzyme increased
|
0.06%
1/1718
|
0.29%
5/1711
|
|
Investigations
International normalised ratio fluctuation
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Metabolism and nutrition disorders
Tetany
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1718
|
0.12%
2/1711
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.17%
3/1718
|
0.12%
2/1711
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/1718
|
0.12%
2/1711
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/1718
|
0.18%
3/1711
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Musculoskeletal and connective tissue disorders
Juvenile arthritis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiosarcoma
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.12%
2/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.17%
3/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.12%
2/1718
|
0.41%
7/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage III
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.12%
2/1718
|
0.23%
4/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer recurrent
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.12%
2/1718
|
0.12%
2/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large cell carcinoma of the respiratory tract stage unspecified
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/1718
|
0.18%
3/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.17%
3/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.12%
2/1718
|
0.23%
4/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.06%
1/1718
|
0.12%
2/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.12%
2/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.12%
2/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.12%
2/1718
|
0.12%
2/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.17%
3/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/1718
|
0.12%
2/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.06%
1/1718
|
0.12%
2/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer recurrent
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma recurrent
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rhabdomyosarcoma
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Waldenstrom's macroglobulinaemia
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma cutis
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ear neoplasm malignant
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix cancer metastatic
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal neoplasm
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.12%
2/1718
|
0.18%
3/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.12%
2/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pelvic neoplasm
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.12%
2/1718
|
0.00%
0/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.12%
2/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penis carcinoma
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer recurrent
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage I
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1718
|
0.12%
2/1711
|
|
Nervous system disorders
Epilepsy
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Nervous system disorders
Facial palsy
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Nervous system disorders
Grand mal convulsion
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Nervous system disorders
Headache
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Nervous system disorders
Migraine
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Nervous system disorders
Mononeuritis
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Nervous system disorders
Multiple sclerosis
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Nervous system disorders
Presyncope
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Nervous system disorders
Syncope
|
0.06%
1/1718
|
0.12%
2/1711
|
|
Nervous system disorders
Transient ischaemic attack
|
0.06%
1/1718
|
0.23%
4/1711
|
|
Nervous system disorders
IIIrd nerve paresis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Nervous system disorders
Cognitive disorder
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Nervous system disorders
Ischaemic stroke
|
0.23%
4/1718
|
0.41%
7/1711
|
|
Nervous system disorders
Parkinson's disease
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Pregnancy, puerperium and perinatal conditions
Post abortion haemorrhage
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Psychiatric disorders
Depression
|
0.17%
3/1718
|
0.12%
2/1711
|
|
Psychiatric disorders
Panic attack
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Psychiatric disorders
Suicide attempt
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Psychiatric disorders
Major depression
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Psychiatric disorders
Psychotic disorder
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Renal and urinary disorders
Anuria
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Renal and urinary disorders
Calculus ureteric
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Renal and urinary disorders
Haematuria
|
0.23%
4/1718
|
0.47%
8/1711
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/1718
|
0.12%
2/1711
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Renal and urinary disorders
Renal failure
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Renal and urinary disorders
Renal failure acute
|
0.06%
1/1718
|
0.18%
3/1711
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.29%
5/1718
|
0.06%
1/1711
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Reproductive system and breast disorders
Penile swelling
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Reproductive system and breast disorders
Prostatitis
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.17%
3/1718
|
0.12%
2/1711
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.23%
4/1718
|
0.12%
2/1711
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.12%
2/1718
|
0.00%
0/1711
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.12%
2/1718
|
0.29%
5/1711
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.06%
1/1718
|
0.12%
2/1711
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.06%
1/1718
|
0.12%
2/1711
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Respiratory, thoracic and mediastinal disorders
Wegener's granulomatosis
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Respiratory, thoracic and mediastinal disorders
Sputum retention
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Skin and subcutaneous tissue disorders
Scar
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Surgical and medical procedures
Bladder catheter removal
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Surgical and medical procedures
Uterine polypectomy
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Surgical and medical procedures
Ileostomy closure
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Vascular disorders
Arterial thrombosis limb
|
0.06%
1/1718
|
0.06%
1/1711
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/1718
|
0.12%
2/1711
|
|
Vascular disorders
Circulatory collapse
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Vascular disorders
Haematoma
|
0.06%
1/1718
|
0.23%
4/1711
|
|
Vascular disorders
Hypertension
|
0.12%
2/1718
|
0.00%
0/1711
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Vascular disorders
Hypotension
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Vascular disorders
Lymphoedema
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Vascular disorders
Peripheral ischaemia
|
0.06%
1/1718
|
0.12%
2/1711
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Vascular disorders
Shock
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Vascular disorders
Thrombosis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Vascular disorders
Post thrombotic syndrome
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Vascular disorders
Femoral artery occlusion
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Vascular disorders
Iliac artery stenosis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.06%
1/1718
|
0.00%
0/1711
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/1718
|
0.06%
1/1711
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.12%
2/1718
|
0.00%
0/1711
|
|
Vascular disorders
May-Thurner syndrome
|
0.00%
0/1718
|
0.06%
1/1711
|
Other adverse events
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=1718 participants at risk
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
|
Enoxaparin/VKA
n=1711 participants at risk
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.8%
100/1718
|
5.3%
91/1711
|
|
Nervous system disorders
Headache
|
5.3%
91/1718
|
4.1%
70/1711
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.2%
90/1718
|
4.3%
74/1711
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60