Trial · NCT02943993
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - Overall | Baseline up to end of observation period (18 months) | 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. |
| Primary | Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | Baseline up to end of observation period (18 months) | 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. |
| Secondary | Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall | Baseline up to end of observation period (18 months) | 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. |
| Secondary | Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment | Baseline up to end of observation period (18 months) | 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. |
| Secondary | Total Number of Venous Thromboembolism Recurrences By Type - Overall | Baseline up to end of observation period (18 months) | 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. |
| Secondary | Duration of Venous Thromboembolism Recurrences, by Type - Overall | Baseline up to end of observation period (18 months) | 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. |
| Secondary | Total Number of Venous Thromboembolism Recurrences (On Edoxaban Treatment) | Baseline up to end of observation period (18 months) | 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. |
| Secondary | Duration of Venous Thromboembolism Events (On Edoxaban Treatment) | Baseline up to end of observation period (18 months) | 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. |
| Secondary | Number of Participants With Risk Factors for Thromboembolic Events at Baseline | at Baseline | 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. |
| Secondary | Duration of Edoxaban Treatment | Baseline up to end of observational period (18 months) | Descriptive statistics were used to report the duration of edoxaban treatment. |
| Secondary | Number of Stroke Events | Baseline up to end of observation period (18 months) | Descriptive statistics were used to report the number of stroke events. For stroke events, absolute number of stroke events were calculated. |
| Secondary | Number of Systemic Embolic Events - Overall | Baseline up to end of observation period (18 months) | Descriptive statistics were used to report the number of systemic embolic events (SEE). For SEE, absolute SEEs were calculated. |
| Secondary | Overview of Participants With Adverse Drug Reactions | Baseline up to end of observation period (18 months) | 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. |
| Secondary | Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%) | Baseline up to end of observational period (18 months) | Adverse drug reactions were reported and coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 20.1. |
| Secondary | Number of Participants With Pre-defined Adverse Drug Reactions | Baseline up to end of observation period (18 months) | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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