Trial Outcomes & Findings for Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe (NCT NCT02943993)
NCT ID: NCT02943993
Last Updated: 2025-04-01
Results Overview
Descriptive statistics were used to report the number of participants with at least 1 symptomatic VTE recurrence. Recurrent VTE events were based on adjudicated events. For the overall symptomatic VTE, precentage of participants (including 95% confidence intervals) were calculated.
COMPLETED
2809 participants
Baseline up to end of observation period (18 months)
2025-04-01
Participant Flow
A total of 2809 participants were included in the All Documented Patient Set defined as participants with a signed ICF and trustworthy data at sites in Germany, Austria, Switzerland, Belgium, The Netherlands, United Kingdom, Ireland, and Italy; a total of 2655 participants were included in the Baseline Analysis Set and a total of 2644 participants were included in the Full Analysis Set.
Participant milestones
| Measure |
ETNA-VTE
Participants with established initial or recurrent acute symptomatic venous thromboembolism (VTE) who were treated with edoxaban according to the Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.
|
|---|---|
|
Overall Study
STARTED
|
2655
|
|
Overall Study
Full Analysis Set
|
2644
|
|
Overall Study
COMPLETED
|
2325
|
|
Overall Study
NOT COMPLETED
|
330
|
Reasons for withdrawal
| Measure |
ETNA-VTE
Participants with established initial or recurrent acute symptomatic venous thromboembolism (VTE) who were treated with edoxaban according to the Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
52
|
|
Overall Study
Transfer to another institution
|
6
|
|
Overall Study
Lost to Follow-up
|
135
|
|
Overall Study
Death
|
98
|
|
Overall Study
Other reason for premature termination
|
32
|
|
Overall Study
Missing reason for termination
|
7
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ETNA-VTE
n=2644 Participants
Participants with established acute initial or recurrent VTE who were treated with edoxaban according to Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.
|
|---|---|
|
Age, Continuous
|
65.0 years
n=2644 Participants
|
|
Age, Customized
<65 years
|
1312 Participants
n=2644 Participants
|
|
Age, Customized
≥65 and <75 years
|
593 Participants
n=2644 Participants
|
|
Age, Customized
≥75 years
|
739 Participants
n=2644 Participants
|
|
Sex: Female, Male
Female
|
1231 Participants
n=2644 Participants
|
|
Sex: Female, Male
Male
|
1413 Participants
n=2644 Participants
|
|
Region of Enrollment
Germany
|
722 participants
n=2644 Participants
|
|
Region of Enrollment
Austria
|
182 participants
n=2644 Participants
|
|
Region of Enrollment
Switzerland
|
84 participants
n=2644 Participants
|
|
Region of Enrollment
Belgium
|
372 participants
n=2644 Participants
|
|
Region of Enrollment
Netherlands
|
321 participants
n=2644 Participants
|
|
Region of Enrollment
United Kingdom
|
113 participants
n=2644 Participants
|
|
Region of Enrollment
Ireland
|
17 participants
n=2644 Participants
|
|
Region of Enrollment
Italy
|
833 participants
n=2644 Participants
|
PRIMARY outcome
Timeframe: Baseline up to end of observation period (18 months)Population: VTE recurrence was assessed in the Full Analysis Set.
Descriptive statistics were used to report the number of participants with at least 1 symptomatic VTE recurrence. Recurrent VTE events were based on adjudicated events. For the overall symptomatic VTE, precentage of participants (including 95% confidence intervals) were calculated.
Outcome measures
| Measure |
ETNA-VTE
n=2644 Participants
Participants with established acute initial or recurrent VTE who were treated with edoxaban according to Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.
|
|---|---|
|
Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - Overall
|
3.8 Percentage of VTE recurrence
Interval 3.09 to 4.58
|
PRIMARY outcome
Timeframe: Baseline up to end of observation period (18 months)Population: Bleeding events were assessed in the Full Analysis Set.
Descriptive statistics were used to report the number of participants with bleeding events. For the analysis of bleeding events, absolute number of participants were calculated.
Outcome measures
| Measure |
ETNA-VTE
n=2644 Participants
Participants with established acute initial or recurrent VTE who were treated with edoxaban according to Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.
|
|---|---|
|
Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment
Provoked bleeding
|
115 participants
|
|
Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment
Participants with any bleeding events
|
304 participants
Interval 10.31 to 12.78
|
|
Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment
At least 1 major bleeding event
|
38 participants
Interval 0.99 to 1.92
|
|
Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment
Clinically relevant non-major bleeding event
|
82 participants
|
|
Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment
Minor
|
300 participants
|
|
Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment
Gastrointestinal bleeding event
|
77 participants
|
|
Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment
Epidural or subdural haematoma bleeding event
|
4 participants
|
|
Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment
Intra-ocular bleeding event
|
5 participants
|
|
Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment
Intra-articular bleeding event
|
3 participants
|
|
Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment
Pleural bleeding event
|
1 participants
|
|
Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment
Other bleeding event
|
319 participants
|
|
Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment
Spontaneous bleeding
|
287 participants
|
|
Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment
Unknown bleeding
|
18 participants
|
SECONDARY outcome
Timeframe: Baseline up to end of observation period (18 months)Population: Real word safety events were assessed in the Full Analysis Set.
Descriptive statistics were used to report the number of participants experiencing recurrent VTE and at least 1 real world safety event. VTE recurrence data were reported by recurrent deep vein thrombosis (DVT), recurrent pulmonary embolism (PE) with DVT, and recurrent PE only. Recurrent VTE events were based on adjudicated events. Real world safety events included all-cause death, cardiovascular (CV)-related death, VTE-related death, stroke, systemic embolic event, and hospitalization related to CV. For recurrent VTE and real world safety events, absolute and relative frequencies (including 95% confidence intervals) were calculated.
Outcome measures
| Measure |
ETNA-VTE
n=2644 Participants
Participants with established acute initial or recurrent VTE who were treated with edoxaban according to Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.
|
|---|---|
|
Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall
Recurrent DVT only
|
2.3 Percentage of real world safety events
Interval 1.77 to 2.95
|
|
Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall
Recurrent PE with DVT
|
0.3 Percentage of real world safety events
Interval 0.11 to 0.54
|
|
Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall
Recurrent PE only
|
1.2 Percentage of real world safety events
Interval 0.8 to 1.66
|
|
Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall
All-cause death
|
3.6 Percentage of real world safety events
Interval 2.92 to 4.37
|
|
Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall
Cardiovascular-related death
|
0.9 Percentage of real world safety events
Interval 0.55 to 1.3
|
|
Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall
Venous thromboembolism-related death
|
0 Percentage of real world safety events
Interval 0.0 to 0.21
|
|
Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall
Stroke
|
1.0 Percentage of real world safety events
Interval 0.64 to 1.44
|
|
Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall
Systemic embolic event
|
0.1 Percentage of real world safety events
Interval 0.01 to 0.27
|
|
Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall
Hospitalization related to CV
|
9.6 Percentage of real world safety events
Interval 8.47 to 10.75
|
SECONDARY outcome
Timeframe: Baseline up to end of observation period (18 months)Population: VTE recurrence was assessed in the Full Analysis Set.
Descriptive statistics were used to report the number of participants with overall symptomatic VTE recurrence. VTE recurrence data were further reported by recurrent deep venous thrombosis (DVT), recurrent pulmonary embolism (PE) with deep venous thrombosis (DVT), and recurrent PE only. Recurrent VTE events were based on adjudicated events. For symptomatic VTE recurrence, percentage of participants (95% confidence intervals) were calculated.
Outcome measures
| Measure |
ETNA-VTE
n=2644 Participants
Participants with established acute initial or recurrent VTE who were treated with edoxaban according to Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.
|
|---|---|
|
Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment
VTE-related death
|
0 Percentage of VTE recurrence
Interval 0.0 to 0.21
|
|
Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment
Recurrent VTE
|
1.4 Percentage of VTE recurrence
Interval 0.99 to 1.92
|
|
Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment
Recurrent DVT only
|
1.0 Percentage of VTE recurrence
Interval 0.67 to 1.48
|
|
Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment
Recurrent PE with DVT
|
0 Percentage of VTE recurrence
Interval 0.0 to 0.21
|
|
Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment
Recurrent PE only
|
0.3 Percentage of VTE recurrence
Interval 0.16 to 0.65
|
|
Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment
All-cause death
|
1.9 Percentage of VTE recurrence
Interval 1.41 to 2.49
|
|
Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment
CV-related death
|
0.4 Percentage of VTE recurrence
Interval 0.21 to 0.74
|
|
Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment
Stroke
|
0.6 Percentage of VTE recurrence
Interval 0.32 to 0.93
|
|
Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment
Systemic embolic event
|
0 Percentage of VTE recurrence
Interval 0.0 to 0.21
|
|
Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment
Hospitalization-related to cardiovascular
|
6.3 Percentage of VTE recurrence
Interval 5.42 to 7.31
|
SECONDARY outcome
Timeframe: Baseline up to end of observation period (18 months)Population: Number of VTE recurrences were assessed in the Full Analysis Set.
Descriptive statistics were used to describe the number of VTE events reported by the patient. For VTE recurrences, absolute number of VTE events were calculated.
Outcome measures
| Measure |
ETNA-VTE
n=2644 Participants
Participants with established acute initial or recurrent VTE who were treated with edoxaban according to Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.
|
|---|---|
|
Total Number of Venous Thromboembolism Recurrences By Type - Overall
Total number of VTE recurrences
|
105 VTE recurrences
|
|
Total Number of Venous Thromboembolism Recurrences By Type - Overall
Deep vein thrombosis (DVT) only
|
64 VTE recurrences
|
|
Total Number of Venous Thromboembolism Recurrences By Type - Overall
Pulmonary embolism with DVT
|
7 VTE recurrences
|
|
Total Number of Venous Thromboembolism Recurrences By Type - Overall
Pulmonary embolism only
|
32 VTE recurrences
|
SECONDARY outcome
Timeframe: Baseline up to end of observation period (18 months)Population: Duration of VTE recurrences was assessed in patients with available start and stop data in the Full Analysis Set.
Descriptive statistics were used to assess the duration of VTE events reported by the patient. For VTE recurrences, median duration of VTE events (interquartile range) were calculated.
Outcome measures
| Measure |
ETNA-VTE
n=2644 Participants
Participants with established acute initial or recurrent VTE who were treated with edoxaban according to Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.
|
|---|---|
|
Duration of Venous Thromboembolism Recurrences, by Type - Overall
Total number of VTE recurrences
|
18.0 days
Interval 8.0 to 93.0
|
|
Duration of Venous Thromboembolism Recurrences, by Type - Overall
Deep vein thrombosis (DVT) only
|
44.5 days
Interval 8.0 to 95.0
|
|
Duration of Venous Thromboembolism Recurrences, by Type - Overall
Pulmonary embolism with DVT
|
8.0 days
Interval 5.0 to 146.0
|
|
Duration of Venous Thromboembolism Recurrences, by Type - Overall
Pulmonary embolism only
|
16.0 days
Interval 8.0 to 93.0
|
SECONDARY outcome
Timeframe: Baseline up to end of observation period (18 months)Population: Number of VTE recurrences were assessed in the Full Analysis Set.
Descriptive statistics were used to assess the number of recurrent VTE events reported by the patient. For VTE recurrences, absolute number of VTE recurrences were calculated.
Outcome measures
| Measure |
ETNA-VTE
n=2644 Participants
Participants with established acute initial or recurrent VTE who were treated with edoxaban according to Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.
|
|---|---|
|
Total Number of Venous Thromboembolism Recurrences (On Edoxaban Treatment)
Total number of VTE recurrences
|
39 VTE recurrences
|
|
Total Number of Venous Thromboembolism Recurrences (On Edoxaban Treatment)
Deep vein thrombosis (DVT) only
|
28 VTE recurrences
|
|
Total Number of Venous Thromboembolism Recurrences (On Edoxaban Treatment)
Pulmonary embolism with DVT
|
1 VTE recurrences
|
|
Total Number of Venous Thromboembolism Recurrences (On Edoxaban Treatment)
Pulmonary embolism only
|
9 VTE recurrences
|
SECONDARY outcome
Timeframe: Baseline up to end of observation period (18 months)Population: Duration of VTE recurrences was assessed in patients with available start and stop data in the Full Analysis Set.
Descriptive statistics were used to assess the duration of VTE events reported by the patient. For VTE events, median duration of VTE events (interquartile range) were calculated.
Outcome measures
| Measure |
ETNA-VTE
n=2644 Participants
Participants with established acute initial or recurrent VTE who were treated with edoxaban according to Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.
|
|---|---|
|
Duration of Venous Thromboembolism Events (On Edoxaban Treatment)
Total number of VTE recurrences
|
11.0 days
Interval 8.0 to 20.0
|
|
Duration of Venous Thromboembolism Events (On Edoxaban Treatment)
Deep vein thrombosis (DVT) only
|
9.5 days
Interval 8.0 to 20.0
|
|
Duration of Venous Thromboembolism Events (On Edoxaban Treatment)
Pulmonary embolism with DVT
|
0 days
Interval 0.0 to 0.0
|
|
Duration of Venous Thromboembolism Events (On Edoxaban Treatment)
Pulmonary embolism only
|
15.0 days
Interval 8.0 to 16.0
|
SECONDARY outcome
Timeframe: at BaselinePopulation: Risk factors were assessed in the Full Analysis Set.
Descriptive statistics were used to assess the number of participants with risk factors for thromboembolic events. For risk factors for thromboembolic events, absolute number of participants with risk factors (percentage) were calculated.
Outcome measures
| Measure |
ETNA-VTE
n=2644 Participants
Participants with established acute initial or recurrent VTE who were treated with edoxaban according to Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.
|
|---|---|
|
Number of Participants With Risk Factors for Thromboembolic Events at Baseline
Puerperium
|
9 Participants
|
|
Number of Participants With Risk Factors for Thromboembolic Events at Baseline
Prolonged immobilisation
|
401 Participants
|
|
Number of Participants With Risk Factors for Thromboembolic Events at Baseline
>5 days in bed
|
218 Participants
|
|
Number of Participants With Risk Factors for Thromboembolic Events at Baseline
History of major surgery trauma
|
359 Participants
|
|
Number of Participants With Risk Factors for Thromboembolic Events at Baseline
Known thrombophilic conditions
|
111 Participants
|
SECONDARY outcome
Timeframe: Baseline up to end of observational period (18 months)Population: Duration of edoxaban treatment was assessed in the Full Analysis Set.
Descriptive statistics were used to report the duration of edoxaban treatment.
Outcome measures
| Measure |
ETNA-VTE
n=2644 Participants
Participants with established acute initial or recurrent VTE who were treated with edoxaban according to Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.
|
|---|---|
|
Duration of Edoxaban Treatment
Month 6 ongoing
|
1842 Participants
|
|
Duration of Edoxaban Treatment
Month 12 ongoing
|
1272 Participants
|
|
Duration of Edoxaban Treatment
Month 18 ongoing
|
713 Participants
|
|
Duration of Edoxaban Treatment
Month 1 ongoing
|
2527 Participants
|
|
Duration of Edoxaban Treatment
Month 3 ongoing
|
2346 Participants
|
|
Duration of Edoxaban Treatment
Participants off edoxaban treatment at 18 months
|
1910 Participants
|
SECONDARY outcome
Timeframe: Baseline up to end of observation period (18 months)Population: Stroke events were assessed in the Full Analysis Set.
Descriptive statistics were used to report the number of stroke events. For stroke events, absolute number of stroke events were calculated.
Outcome measures
| Measure |
ETNA-VTE
n=2644 Participants
Participants with established acute initial or recurrent VTE who were treated with edoxaban according to Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.
|
|---|---|
|
Number of Stroke Events
On treatment: Total number of stroke events
|
16 events
|
|
Number of Stroke Events
Overall treatment: Total number of stroke events
|
27 events
|
|
Number of Stroke Events
Overall treatment: Ischemic events
|
17 events
|
|
Number of Stroke Events
Overall treatment: Haemorrhagic events
|
5 events
|
|
Number of Stroke Events
Overall treatment: Unknown events
|
5 events
|
|
Number of Stroke Events
On treatment: Ischemic events
|
12 events
|
|
Number of Stroke Events
On treatment: Haemorrhagic events
|
3 events
|
|
Number of Stroke Events
On treatment: Unknown events
|
1 events
|
SECONDARY outcome
Timeframe: Baseline up to end of observation period (18 months)Population: Systemic embolic events were assessed in the Full Analysis Set.
Descriptive statistics were used to report the number of systemic embolic events (SEE). For SEE, absolute SEEs were calculated.
Outcome measures
| Measure |
ETNA-VTE
n=2644 Participants
Participants with established acute initial or recurrent VTE who were treated with edoxaban according to Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.
|
|---|---|
|
Number of Systemic Embolic Events - Overall
Upper/lower extremity
|
1 Systemic embolic events
|
|
Number of Systemic Embolic Events - Overall
Renal
|
1 Systemic embolic events
|
SECONDARY outcome
Timeframe: Baseline up to end of observation period (18 months)Population: Adverse drug reactions were assessed in the Baseline Analysis Set.
Descriptive statistics were used to report an overview of participants with adverse drug reactions (ADR). ADRs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 20.1.
Outcome measures
| Measure |
ETNA-VTE
n=2655 Participants
Participants with established acute initial or recurrent VTE who were treated with edoxaban according to Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.
|
|---|---|
|
Overview of Participants With Adverse Drug Reactions
Death due to ADR
|
2 Participants
|
|
Overview of Participants With Adverse Drug Reactions
Participants with at least 1 ADR
|
142 Participants
|
|
Overview of Participants With Adverse Drug Reactions
Participants with at least 1 serious ADR
|
59 Participants
|
|
Overview of Participants With Adverse Drug Reactions
Study discontinuation due to ADR
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to end of observational period (18 months)Population: Adverse drug reactions were assessed in the Baseline Analysis Set.
Adverse drug reactions were reported and coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 20.1.
Outcome measures
| Measure |
ETNA-VTE
n=2655 Participants
Participants with established acute initial or recurrent VTE who were treated with edoxaban according to Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.
|
|---|---|
|
Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%)
Haemorrhage
|
35 Participants
|
|
Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%)
Gastrointestinal haemorrhage
|
12 Participants
|
|
Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%)
Menorrhagia
|
12 Participants
|
|
Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%)
Epistaxis
|
11 Participants
|
|
Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%)
Fatigue
|
8 Participants
|
|
Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%)
Nausea
|
8 Participants
|
|
Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%)
Dizziness
|
7 Participants
|
|
Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%)
Rash
|
7 Participants
|
|
Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%)
Headache
|
5 Participants
|
|
Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%)
Pruritus
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline up to end of observation period (18 months)Population: Adverse drug reactions were assessed in the Baseline Analysis Set.
Descriptive statistics were used to report the number of participants with pre-defined adverse drug reactions (ADR). ADRs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 20.1.
Outcome measures
| Measure |
ETNA-VTE
n=2655 Participants
Participants with established acute initial or recurrent VTE who were treated with edoxaban according to Summary of Product Characteristics (SmPC) based on the clinical decision of the treating physician.
|
|---|---|
|
Number of Participants With Pre-defined Adverse Drug Reactions
Systemic embolic events
|
0 Participants
|
|
Number of Participants With Pre-defined Adverse Drug Reactions
Stroke
|
2 Participants
|
|
Number of Participants With Pre-defined Adverse Drug Reactions
Bleeding events
|
75 Participants
|
|
Number of Participants With Pre-defined Adverse Drug Reactions
Non-valvular atrial fibrillation
|
0 Participants
|
|
Number of Participants With Pre-defined Adverse Drug Reactions
Malignancy
|
0 Participants
|
|
Number of Participants With Pre-defined Adverse Drug Reactions
Others
|
4 Participants
|
Adverse Events
ETNA-VTE
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place