Trial · NCT00439777
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 3-, 6-, or 12-month study treatment period | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment | 3-, 6-, or 12-month study treatment period | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment | 3-, 6-, or 12-month study treatment period | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Recurrent PE Until the Intended End of Study Treatment | 3-, 6- or 12-month study treatment period | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment | 3-, 6- or 12-month study treatment period | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose) | 3-, 6- or 12-month study treatment period | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With All Deaths | 3-, 6- or 12-month study treatment period | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose) | 3-, 6- or 12-month study treatment period | 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. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment | 3-, 6- or 12-month study treatment period | 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. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Symptomatic Recurrent VTE (i.e. the Composite of Recurrent DVT or Fatal or Non-fatal PE) During Observational Period | Up to 30 days after the last intake of study medication | 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. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period | Up to 30 days after the last intake of study medication | 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. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period | Up to 30 days after the last intake of study medication | 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. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Recurrent DVT During Observational Period | Up to 30 days after the last intake of study medication | 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. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period | Up to 30 days after the last intake of study medication | 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. | Percentage of participants | NUMBER |
| POST_HOC | Percentage of Participants With an Event for Net Clinical Benefit 2 Until the Intended End of Study Treatment | 3-, 6- or 12-month study treatment period | 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. | Percentage of participants | NUMBER |
| POST_HOC | Percentage of Participants With an Event for Net Clinical Benefit 2 During Observational Period | Up to 30 days after the last intake of study medication | 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. | Percentage of participants | NUMBER |
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.
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