Trial Outcomes & Findings for Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study (NCT NCT00439777)
NCT ID: NCT00439777
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4833 participants
Primary outcome timeframe
3-, 6-, or 12-month study treatment period
Results posted on
2014-02-27
Participant Flow
Participants with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic deep vein thrombosis (DVT) were recruited at specialized study sites.
Out of 4843 participants screened, 10 failed screening (6 due to protocol violations, 2 due to investigator decision and another 2 subjects due to technical problems \[interactive voice response system did not work properly\]). 4833 participants were randomized (2420 to rivaroxaban and 2413 to enoxaparin/VKA).
Participant milestones
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
|
Enoxaparin/VKA
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
|
|---|---|---|
|
Treatment Period
STARTED
|
2420
|
2413
|
|
Treatment Period
Participants Received Treatment
|
2412
|
2405
|
|
Treatment Period
COMPLETED
|
2001
|
1954
|
|
Treatment Period
NOT COMPLETED
|
419
|
459
|
|
Observational Period
STARTED
|
2206
|
2197
|
|
Observational Period
COMPLETED
|
2165
|
2156
|
|
Observational Period
NOT COMPLETED
|
41
|
41
|
Reasons for withdrawal
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
|
Enoxaparin/VKA
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
|
|---|---|---|
|
Treatment Period
Death
|
29
|
21
|
|
Treatment Period
Study terminated by sponsor
|
125
|
132
|
|
Treatment Period
Site closed by investigator
|
0
|
1
|
|
Treatment Period
Did not take study treatment
|
7
|
8
|
|
Treatment Period
Adverse Event
|
111
|
92
|
|
Treatment Period
Protocol Violation
|
23
|
30
|
|
Treatment Period
Withdrawal by Subject
|
66
|
118
|
|
Treatment Period
Lack of Efficacy
|
1
|
4
|
|
Treatment Period
Lost to Follow-up
|
8
|
10
|
|
Treatment Period
Protocol driven decision point
|
1
|
3
|
|
Treatment Period
Physician Decision
|
7
|
18
|
|
Treatment Period
Clinical endpoint reached
|
26
|
13
|
|
Treatment Period
Technical problems
|
3
|
1
|
|
Treatment Period
Participant convenience
|
12
|
8
|
|
Observational Period
Protocol Violation
|
0
|
2
|
|
Observational Period
Withdrawal by Subject
|
9
|
5
|
|
Observational Period
Lost to Follow-up
|
1
|
11
|
|
Observational Period
Death
|
27
|
20
|
|
Observational Period
Study terminated by sponsor
|
3
|
1
|
|
Observational Period
Protocol driven decision point
|
0
|
1
|
|
Observational Period
Lack of Efficacy
|
1
|
0
|
|
Observational Period
Technical problems
|
0
|
1
|
Baseline Characteristics
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study
Baseline characteristics by cohort
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=2419 Participants
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
|
Enoxaparin/VKA
n=2413 Participants
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
|
Total
n=4832 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
1309 Participants
n=5 Participants
|
1247 Participants
n=7 Participants
|
2556 Participants
n=5 Participants
|
|
Age, Continuous
|
57.9 Years
STANDARD_DEVIATION 17.3 • n=5 Participants
|
57.5 Years
STANDARD_DEVIATION 17.2 • n=7 Participants
|
57.7 Years
STANDARD_DEVIATION 17.3 • n=5 Participants
|
|
Age, Customized
18 - < 40 years
|
410 Participants
n=5 Participants
|
432 Participants
n=7 Participants
|
842 Participants
n=5 Participants
|
|
Age, Customized
40 - < 60 years
|
794 Participants
n=5 Participants
|
779 Participants
n=7 Participants
|
1573 Participants
n=5 Participants
|
|
Age, Customized
60 - < 75 years
|
740 Participants
n=5 Participants
|
754 Participants
n=7 Participants
|
1494 Participants
n=5 Participants
|
|
Age, Customized
≥ 75 years
|
475 Participants
n=5 Participants
|
448 Participants
n=7 Participants
|
923 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1110 Participants
n=5 Participants
|
1166 Participants
n=7 Participants
|
2276 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=2419 Participants
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
|
Enoxaparin/VKA
n=2413 Participants
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 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
|
1.8 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=2419 Participants
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
|
Enoxaparin/VKA
n=2413 Participants
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 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
|
3.4 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=2419 Participants
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
|
Enoxaparin/VKA
n=2413 Participants
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
|
|---|---|---|
|
Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment
|
3.4 Percentage of participants
|
4.0 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 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=2419 Participants
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
|
Enoxaparin/VKA
n=2413 Participants
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
|
|---|---|---|
|
Percentage of Participants With Recurrent PE Until the Intended End of Study Treatment
|
1.4 Percentage of participants
|
1.2 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=2419 Participants
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
|
Enoxaparin/VKA
n=2413 Participants
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
|
|---|---|---|
|
Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment
|
0.7 Percentage of participants
|
0.8 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=2412 Participants
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
|
Enoxaparin/VKA
n=2405 Participants
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
|
|---|---|---|
|
Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)
|
10.3 Percentage of participants
|
11.4 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=2412 Participants
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
|
Enoxaparin/VKA
n=2405 Participants
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
|
|---|---|---|
|
Percentage of Participants With All Deaths
All post-randomization
|
2.6 Percentage of participants
|
2.1 Percentage of participants
|
|
Percentage of Participants With All Deaths
Treatment-emergent (time window: 2 days)
|
1.2 Percentage of participants
|
0.8 Percentage of participants
|
|
Percentage of Participants With All Deaths
Treatment-emergent (time window: 7 days)
|
1.5 Percentage of participants
|
1.1 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 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=2412 Participants
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
|
Enoxaparin/VKA
n=2405 Participants
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
|
|---|---|---|
|
Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)
|
1.5 Percentage of participants
|
1.5 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=2419 Participants
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
|
Enoxaparin/VKA
n=2413 Participants
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
|
|---|---|---|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment
Death (PE)
|
0.1 Percentage of participants
|
0.04 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)
|
0.3 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
Symptomatic PE and DVT
|
0.0 Percentage of participants
|
0.1 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment
Symptomatic recurrent PE only
|
1.0 Percentage of participants
|
0.8 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment
Symptomatic recurrent DVT only
|
0.7 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment
Death (bleeding)
|
0.2 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
Death (cardiovascular)
|
0.4 Percentage of participants
|
0.1 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment
Death (other)
|
1.3 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment
Major bleeding
|
1.4 Percentage of participants
|
2.4 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), and/or case summaries.
Outcome measures
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=2211 Participants
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
|
Enoxaparin/VKA
n=2201 Participants
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
|
|---|---|---|
|
Percentage of Participants With Symptomatic Recurrent VTE (i.e. the Composite of Recurrent DVT or Fatal or Non-fatal PE) During Observational Period
|
0.9 Percentage of participants
|
0.7 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=2213 Participants
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
|
Enoxaparin/VKA
n=2203 Participants
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
|
|---|---|---|
|
Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period
|
2.1 Percentage of participants
|
1.5 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.
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=2212 Participants
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
|
Enoxaparin/VKA
n=2201 Participants
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
|
|---|---|---|
|
Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period
|
1.2 Percentage of participants
|
1.2 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=2210 Participants
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
|
Enoxaparin/VKA
n=2201 Participants
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
|
|---|---|---|
|
Percentage of Participants With Recurrent DVT During Observational Period
|
0.3 Percentage of participants
|
0.1 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, 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=2213 Participants
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
|
Enoxaparin/VKA
n=2203 Participants
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
|
|---|---|---|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period
Death (PE)
|
0.09 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 Percentage of participants
|
0.05 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period
Symptomatic PE and DVT
|
0.09 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period
Symptomatic recurrent PE only
|
0.5 Percentage of participants
|
0.5 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period
Symptomatic recurrent DVT only
|
0.2 Percentage of participants
|
0.1 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period
Death (bleeding)
|
0.09 Percentage of participants
|
0.09 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period
Death (cardiovascular)
|
0.3 Percentage of participants
|
0.05 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period
Death (other)
|
0.8 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period
Major bleeding
|
0.3 Percentage of participants
|
0.5 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 (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 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=2419 Participants
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
|
Enoxaparin/VKA
n=2413 Participants
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
|
|---|---|---|
|
Percentage of Participants With an Event for Net Clinical Benefit 2 Until the Intended End of Study Treatment
|
4.5 Percentage of participants
|
4.8 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 (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 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=2213 Participants
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
|
Enoxaparin/VKA
n=2201 Participants
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
|
|---|---|---|
|
Percentage of Participants With an Event for Net Clinical Benefit 2 During Observational Period
|
1.5 Percentage of participants
|
1.4 Percentage of participants
|
Adverse Events
Rivaroxaban (Xarelto, BAY59-7939)
Serious events: 504 serious events
Other events: 1053 other events
Deaths: 0 deaths
Enoxaparin/VKA
Serious events: 495 serious events
Other events: 1065 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=2412 participants at risk
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
|
Enoxaparin/VKA
n=2405 participants at risk
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.37%
9/2412
|
0.21%
5/2405
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.70%
17/2412
|
0.54%
13/2405
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.12%
3/2412
|
0.08%
2/2405
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.25%
6/2412
|
0.33%
8/2405
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.04%
1/2412
|
0.08%
2/2405
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.12%
3/2412
|
0.08%
2/2405
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal cyst
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.37%
9/2412
|
0.46%
11/2405
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/2412
|
0.17%
4/2405
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.17%
4/2412
|
0.33%
8/2405
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.04%
1/2412
|
0.12%
3/2405
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.25%
6/2412
|
0.04%
1/2405
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.17%
4/2412
|
0.04%
1/2405
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.12%
3/2412
|
0.08%
2/2405
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary venous thrombosis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.12%
3/2412
|
0.21%
5/2405
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal haemorrhage
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Social circumstances
Miscarriage of partner
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Surgical and medical procedures
Abortion induced
|
0.08%
2/2412
|
0.12%
3/2405
|
|
Vascular disorders
Aortic aneurysm
|
0.04%
1/2412
|
0.08%
2/2405
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/2412
|
0.08%
2/2405
|
|
Vascular disorders
Aortic dissection
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Vascular disorders
Aortic thrombosis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Vascular disorders
Circulatory collapse
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Vascular disorders
Embolism arterial
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Vascular disorders
Haematoma
|
0.17%
4/2412
|
0.17%
4/2405
|
|
Vascular disorders
Hypertension
|
0.04%
1/2412
|
0.12%
3/2405
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Vascular disorders
Hypotension
|
0.12%
3/2412
|
0.04%
1/2405
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Vascular disorders
Iliac artery thrombosis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Vascular disorders
Orthostatic hypotension
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Vascular disorders
Peripheral ischaemia
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Vascular disorders
Temporal arteritis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Vascular disorders
Vena cava thrombosis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Vascular disorders
Lymphocele
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Vascular disorders
Intra-abdominal haematoma
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Vascular disorders
Varicophlebitis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Vascular disorders
Intra-abdominal haemorrhage
|
0.04%
1/2412
|
0.08%
2/2405
|
|
Vascular disorders
Paradoxical embolism
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Vascular disorders
Distributive shock
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Blood and lymphatic system disorders
Anaemia
|
0.58%
14/2412
|
0.25%
6/2405
|
|
Blood and lymphatic system disorders
Anaemia folate deficiency
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/2412
|
0.08%
2/2405
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2412
|
0.08%
2/2405
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Blood and lymphatic system disorders
Pernicious anaemia
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Blood and lymphatic system disorders
Splenic haemorrhage
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.04%
1/2412
|
0.08%
2/2405
|
|
Cardiac disorders
Acute myocardial infarction
|
0.25%
6/2412
|
0.42%
10/2405
|
|
Cardiac disorders
Angina pectoris
|
0.12%
3/2412
|
0.17%
4/2405
|
|
Cardiac disorders
Angina unstable
|
0.29%
7/2412
|
0.08%
2/2405
|
|
Cardiac disorders
Arrhythmia
|
0.08%
2/2412
|
0.04%
1/2405
|
|
Cardiac disorders
Atrial fibrillation
|
0.33%
8/2412
|
0.46%
11/2405
|
|
Cardiac disorders
Atrial flutter
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Cardiac disorders
Cardiac arrest
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Cardiac disorders
Cardiac failure
|
0.37%
9/2412
|
0.29%
7/2405
|
|
Cardiac disorders
Cardiac failure acute
|
0.17%
4/2412
|
0.08%
2/2405
|
|
Cardiac disorders
Cardiac failure congestive
|
0.17%
4/2412
|
0.21%
5/2405
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Cardiac disorders
Cardiogenic shock
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Cardiac disorders
Cor pulmonale
|
0.12%
3/2412
|
0.04%
1/2405
|
|
Cardiac disorders
Cor pulmonale acute
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Cardiac disorders
Cor pulmonale chronic
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Cardiac disorders
Coronary artery disease
|
0.04%
1/2412
|
0.33%
8/2405
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Cardiac disorders
Left ventricular failure
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Cardiac disorders
Mitral valve incompetence
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/2412
|
0.08%
2/2405
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Cardiac disorders
Palpitations
|
0.08%
2/2412
|
0.08%
2/2405
|
|
Cardiac disorders
Pericardial effusion
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.04%
1/2412
|
0.08%
2/2405
|
|
Cardiac disorders
Pericarditis
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Cardiac disorders
Right ventricular failure
|
0.12%
3/2412
|
0.00%
0/2405
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/2412
|
0.08%
2/2405
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.04%
1/2412
|
0.17%
4/2405
|
|
Cardiac disorders
Tachycardia
|
0.04%
1/2412
|
0.08%
2/2405
|
|
Cardiac disorders
Ventricular fibrillation
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Cardiac disorders
Ventricular tachycardia
|
0.12%
3/2412
|
0.04%
1/2405
|
|
Cardiac disorders
Coronary artery dissection
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Cardiac disorders
Acute left ventricular failure
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Ear and labyrinth disorders
Vertigo
|
0.12%
3/2412
|
0.17%
4/2405
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Endocrine disorders
Addison's disease
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Endocrine disorders
Adrenal haemorrhage
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Endocrine disorders
Diabetes insipidus
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Endocrine disorders
Goitre
|
0.00%
0/2412
|
0.08%
2/2405
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Eye disorders
Amaurosis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Eye disorders
Cataract
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Eye disorders
Diplopia
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/2412
|
0.12%
3/2405
|
|
Eye disorders
Eye pain
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Eye disorders
Vision blurred
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Eye disorders
Age-related macular degeneration
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Gastrointestinal disorders
Abdominal pain
|
0.04%
1/2412
|
0.17%
4/2405
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.04%
1/2412
|
0.17%
4/2405
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Gastrointestinal disorders
Anorectal disorder
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Gastrointestinal disorders
Colitis
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Colonic polyp
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Colonic stenosis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Dental caries
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Diarrhoea
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Diverticulum
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Diverticulum oesophageal
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Dyspepsia
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Dysphagia
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Gastrointestinal disorders
Gastric perforation
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Gastrointestinal disorders
Gastritis
|
0.04%
1/2412
|
0.08%
2/2405
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.29%
7/2412
|
0.21%
5/2405
|
|
Gastrointestinal disorders
Haematemesis
|
0.17%
4/2412
|
0.08%
2/2405
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.04%
1/2412
|
0.08%
2/2405
|
|
Gastrointestinal disorders
Melaena
|
0.08%
2/2412
|
0.29%
7/2405
|
|
Gastrointestinal disorders
Nausea
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.25%
6/2412
|
0.25%
6/2405
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Gastrointestinal disorders
Tooth loss
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.08%
2/2412
|
0.08%
2/2405
|
|
Gastrointestinal disorders
Vomiting
|
0.12%
3/2412
|
0.12%
3/2405
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Gastrointestinal disorders
Gastrointestinal dysplasia
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Subileus
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.08%
2/2412
|
0.12%
3/2405
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.04%
1/2412
|
0.08%
2/2405
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/2412
|
0.08%
2/2405
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.04%
1/2412
|
0.12%
3/2405
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/2412
|
0.08%
2/2405
|
|
General disorders
Asthenia
|
0.04%
1/2412
|
0.00%
0/2405
|
|
General disorders
Chest discomfort
|
0.04%
1/2412
|
0.00%
0/2405
|
|
General disorders
Chest pain
|
0.87%
21/2412
|
1.1%
27/2405
|
|
General disorders
Cyst
|
0.00%
0/2412
|
0.04%
1/2405
|
|
General disorders
Death
|
0.17%
4/2412
|
0.08%
2/2405
|
|
General disorders
Fatigue
|
0.08%
2/2412
|
0.00%
0/2405
|
|
General disorders
Gait disturbance
|
0.04%
1/2412
|
0.00%
0/2405
|
|
General disorders
Granuloma
|
0.00%
0/2412
|
0.04%
1/2405
|
|
General disorders
Impaired healing
|
0.00%
0/2412
|
0.04%
1/2405
|
|
General disorders
Malaise
|
0.04%
1/2412
|
0.00%
0/2405
|
|
General disorders
Multi-organ failure
|
0.04%
1/2412
|
0.00%
0/2405
|
|
General disorders
Oedema peripheral
|
0.04%
1/2412
|
0.08%
2/2405
|
|
General disorders
Pyrexia
|
0.17%
4/2412
|
0.08%
2/2405
|
|
General disorders
Sudden death
|
0.12%
3/2412
|
0.04%
1/2405
|
|
General disorders
General physical health deterioration
|
0.12%
3/2412
|
0.08%
2/2405
|
|
General disorders
Adverse drug reaction
|
0.00%
0/2412
|
0.04%
1/2405
|
|
General disorders
Drug intolerance
|
0.00%
0/2412
|
0.04%
1/2405
|
|
General disorders
Non-cardiac chest pain
|
0.25%
6/2412
|
0.12%
3/2405
|
|
General disorders
Implant site thrombosis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
General disorders
Device deposit issue
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Hepatobiliary disorders
Bile duct stone
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Hepatobiliary disorders
Biliary colic
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Hepatobiliary disorders
Cholangitis
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Hepatobiliary disorders
Cholecystitis
|
0.08%
2/2412
|
0.04%
1/2405
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.17%
4/2412
|
0.21%
5/2405
|
|
Hepatobiliary disorders
Hepatic failure
|
0.04%
1/2412
|
0.08%
2/2405
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Hepatobiliary disorders
Hepatic pain
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Hepatobiliary disorders
Hepatitis chronic active
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Hepatobiliary disorders
Jaundice
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Hepatobiliary disorders
Cytolytic hepatitis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Immune system disorders
Antiphospholipid syndrome
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Immune system disorders
Hypersensitivity
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Immune system disorders
Sarcoidosis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Infections and infestations
Appendicitis
|
0.00%
0/2412
|
0.08%
2/2405
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Infections and infestations
Bronchitis
|
0.21%
5/2412
|
0.33%
8/2405
|
|
Infections and infestations
Bronchopneumonia
|
0.17%
4/2412
|
0.17%
4/2405
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Infections and infestations
Cellulitis
|
0.17%
4/2412
|
0.21%
5/2405
|
|
Infections and infestations
Cystitis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Infections and infestations
Diverticulitis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Infections and infestations
Endocarditis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Infections and infestations
Endocarditis bacterial
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Infections and infestations
Gastroenteritis
|
0.12%
3/2412
|
0.00%
0/2405
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Infections and infestations
Herpes simplex
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/2412
|
0.08%
2/2405
|
|
Infections and infestations
Lobar pneumonia
|
0.17%
4/2412
|
0.04%
1/2405
|
|
Infections and infestations
Localised infection
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Infections and infestations
Lower respiratory tract infection
|
0.12%
3/2412
|
0.17%
4/2405
|
|
Infections and infestations
Lung abscess
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Infections and infestations
Mastitis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/2412
|
0.08%
2/2405
|
|
Infections and infestations
Pneumonia
|
0.91%
22/2412
|
0.87%
21/2405
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Infections and infestations
Pyelonephritis
|
0.12%
3/2412
|
0.08%
2/2405
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Infections and infestations
Sepsis
|
0.54%
13/2412
|
0.08%
2/2405
|
|
Infections and infestations
Sinusitis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Infections and infestations
Skin infection
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Infections and infestations
Tracheobronchitis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Infections and infestations
Tuberculosis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Infections and infestations
Urinary tract infection
|
0.29%
7/2412
|
0.17%
4/2405
|
|
Infections and infestations
Viral rash
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Infections and infestations
Wound infection
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Infections and infestations
Urosepsis
|
0.08%
2/2412
|
0.08%
2/2405
|
|
Infections and infestations
Anal abscess
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Infections and infestations
Neutropenic sepsis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Infections and infestations
Appendiceal abscess
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Infections and infestations
Groin abscess
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Infections and infestations
Abscess limb
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Infections and infestations
Abscess soft tissue
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Infections and infestations
Prostate infection
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Infections and infestations
Abscess neck
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Infections and infestations
Pneumonia necrotising
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Infections and infestations
Subdiaphragmatic abscess
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.04%
1/2412
|
0.08%
2/2405
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Infections and infestations
Joint abscess
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Infections and infestations
Wound infection staphylococcal
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Infections and infestations
Intervertebral discitis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Infections and infestations
Lung infection
|
0.12%
3/2412
|
0.17%
4/2405
|
|
Infections and infestations
Respiratory tract infection
|
0.04%
1/2412
|
0.08%
2/2405
|
|
Infections and infestations
Cholecystitis infective
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Infections and infestations
Device related infection
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Infections and infestations
Infectious peritonitis
|
0.17%
4/2412
|
0.00%
0/2405
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.12%
3/2412
|
0.00%
0/2405
|
|
Injury, poisoning and procedural complications
Cerebral haemorrhage traumatic
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Injury, poisoning and procedural complications
Concussion
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Injury, poisoning and procedural complications
Fall
|
0.17%
4/2412
|
0.04%
1/2405
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/2412
|
0.08%
2/2405
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Injury, poisoning and procedural complications
Kidney rupture
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Injury, poisoning and procedural complications
Overdose
|
0.08%
2/2412
|
0.08%
2/2405
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/2412
|
0.08%
2/2405
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Injury, poisoning and procedural complications
Splenic haematoma
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.04%
1/2412
|
0.12%
3/2405
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.04%
1/2412
|
0.12%
3/2405
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/2412
|
0.12%
3/2405
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/2412
|
0.08%
2/2405
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Injury, poisoning and procedural complications
Perirenal haematoma
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/2412
|
0.08%
2/2405
|
|
Injury, poisoning and procedural complications
Contusion
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.08%
2/2412
|
0.12%
3/2405
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Injury, poisoning and procedural complications
Cardiac valve replacement complication
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Investigations
Alanine aminotransferase increased
|
0.25%
6/2412
|
0.37%
9/2405
|
|
Investigations
Aspartate aminotransferase increased
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Investigations
Blood amylase increased
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Investigations
Blood potassium increased
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Investigations
C-reactive protein increased
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Investigations
Coagulation time prolonged
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Investigations
Coagulation time shortened
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Investigations
Haemoglobin decreased
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Investigations
International normalised ratio abnormal
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Investigations
International normalised ratio increased
|
0.04%
1/2412
|
0.17%
4/2405
|
|
Investigations
Liver function test abnormal
|
0.17%
4/2412
|
0.37%
9/2405
|
|
Investigations
Prostatic specific antigen increased
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Investigations
Ultrasound liver abnormal
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Investigations
Medical observation
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Investigations
Transaminases increased
|
0.08%
2/2412
|
0.08%
2/2405
|
|
Investigations
Hepatic enzyme increased
|
0.12%
3/2412
|
0.04%
1/2405
|
|
Metabolism and nutrition disorders
Acidosis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Metabolism and nutrition disorders
Dehydration
|
0.04%
1/2412
|
0.08%
2/2405
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.04%
1/2412
|
0.08%
2/2405
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Metabolism and nutrition disorders
Shock hypoglycaemic
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.08%
2/2412
|
0.08%
2/2405
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.21%
5/2412
|
0.25%
6/2405
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/2412
|
0.12%
3/2405
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.04%
1/2412
|
0.37%
9/2405
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.17%
4/2412
|
0.12%
3/2405
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.12%
3/2412
|
0.04%
1/2405
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.17%
4/2412
|
0.25%
6/2405
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.17%
4/2412
|
0.04%
1/2405
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.12%
3/2412
|
0.04%
1/2405
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute promyelocytic leukaemia
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign oesophageal neoplasm
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer non-resectable
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.04%
1/2412
|
0.08%
2/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/2412
|
0.08%
2/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.33%
8/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.12%
3/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.12%
3/2412
|
0.17%
4/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma malignant
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.08%
2/2412
|
0.17%
4/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pleura
|
0.00%
0/2412
|
0.08%
2/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia vera
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.08%
2/2412
|
0.08%
2/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.08%
2/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.04%
1/2412
|
0.12%
3/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.17%
4/2412
|
0.08%
2/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Histiocytosis haematophagic
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.04%
1/2412
|
0.08%
2/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.21%
5/2412
|
0.17%
4/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.12%
3/2412
|
0.29%
7/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/2412
|
0.08%
2/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pelvic neoplasm
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal marginal zone B-cell lymphoma (MALT type)
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/2412
|
0.08%
2/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/2412
|
0.08%
2/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Inflammatory pseudotumour
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Nervous system disorders
Altered state of consciousness
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Nervous system disorders
Ataxia
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Nervous system disorders
Cauda equina syndrome
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/2412
|
0.17%
4/2405
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Nervous system disorders
Cerebrovascular accident
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Nervous system disorders
Clumsiness
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Nervous system disorders
Coma
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Nervous system disorders
Convulsion
|
0.08%
2/2412
|
0.12%
3/2405
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Nervous system disorders
Depressed level of consciousness
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Nervous system disorders
Dizziness
|
0.12%
3/2412
|
0.12%
3/2405
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Nervous system disorders
Epilepsy
|
0.08%
2/2412
|
0.04%
1/2405
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/2412
|
0.08%
2/2405
|
|
Nervous system disorders
Headache
|
0.12%
3/2412
|
0.17%
4/2405
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Nervous system disorders
Leukoencephalopathy
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Nervous system disorders
Migraine
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Nervous system disorders
Nervous system disorder
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Nervous system disorders
Neuropathy peripheral
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Nervous system disorders
Parkinsonism
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Nervous system disorders
Presyncope
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Nervous system disorders
Sciatica
|
0.08%
2/2412
|
0.04%
1/2405
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Nervous system disorders
Syncope
|
0.33%
8/2412
|
0.25%
6/2405
|
|
Nervous system disorders
Tension headache
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Nervous system disorders
Transient ischaemic attack
|
0.12%
3/2412
|
0.12%
3/2405
|
|
Nervous system disorders
Balance disorder
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Nervous system disorders
Radicular pain
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Nervous system disorders
Ischaemic stroke
|
0.54%
13/2412
|
0.21%
5/2405
|
|
Nervous system disorders
Parkinson's disease
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Pregnancy, puerperium and perinatal conditions
Post abortion haemorrhage
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/2412
|
0.08%
2/2405
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Psychiatric disorders
Anxiety
|
0.21%
5/2412
|
0.12%
3/2405
|
|
Psychiatric disorders
Bipolar I disorder
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Psychiatric disorders
Delusion
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Psychiatric disorders
Depression
|
0.17%
4/2412
|
0.12%
3/2405
|
|
Psychiatric disorders
Mania
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Psychiatric disorders
Panic attack
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Psychiatric disorders
Suicide attempt
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Psychiatric disorders
Somatoform disorder
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Psychiatric disorders
Mental disorder due to a general medical condition
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Renal and urinary disorders
Bladder dilatation
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Renal and urinary disorders
Dysuria
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Renal and urinary disorders
Haematuria
|
0.33%
8/2412
|
0.46%
11/2405
|
|
Renal and urinary disorders
Nephritis
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/2412
|
0.12%
3/2405
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/2412
|
0.12%
3/2405
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Renal and urinary disorders
Renal failure acute
|
0.08%
2/2412
|
0.17%
4/2405
|
|
Renal and urinary disorders
Urinary retention
|
0.08%
2/2412
|
0.00%
0/2405
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Renal and urinary disorders
Renal impairment
|
0.04%
1/2412
|
0.04%
1/2405
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/2412
|
0.08%
2/2405
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.37%
9/2412
|
0.08%
2/2405
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.17%
4/2412
|
0.08%
2/2405
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Reproductive system and breast disorders
Priapism
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.17%
4/2412
|
0.00%
0/2405
|
|
Reproductive system and breast disorders
Vulval disorder
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Reproductive system and breast disorders
Prostatic mass
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.04%
1/2412
|
0.00%
0/2405
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.08%
2/2412
|
0.04%
1/2405
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.04%
1/2412
|
0.17%
4/2405
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.17%
4/2412
|
0.08%
2/2405
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/2412
|
0.04%
1/2405
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/2412
|
0.04%
1/2405
|
Other adverse events
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=2412 participants at risk
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
|
Enoxaparin/VKA
n=2405 participants at risk
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
6.1%
146/2412
|
5.9%
141/2405
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
128/2412
|
5.5%
132/2405
|
|
Gastrointestinal disorders
Nausea
|
4.7%
113/2412
|
5.4%
131/2405
|
|
General disorders
Chest pain
|
7.4%
179/2412
|
7.5%
181/2405
|
|
Infections and infestations
Nasopharyngitis
|
7.8%
188/2412
|
8.1%
195/2405
|
|
Injury, poisoning and procedural complications
Contusion
|
3.9%
95/2412
|
5.5%
133/2405
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.6%
87/2412
|
5.6%
134/2405
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
172/2412
|
6.7%
162/2405
|
|
Nervous system disorders
Headache
|
8.1%
196/2412
|
7.4%
177/2405
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.6%
160/2412
|
7.4%
179/2405
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.5%
156/2412
|
6.1%
147/2405
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.5%
229/2412
|
8.5%
205/2405
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60