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Trial · NCT00657150

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period28-35 days
Full Analysis Set (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, had evaluable negative venogram for both distal and proximal DVT in both legs or positive venography in any 1 segment of 1 or both legs, or confirmed symptomatic DVT, PE or death during the treatment period.)
ParticipantsNUMBER
SECONDARYNumber of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period28-35 days
Full Analysis Set-major (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, had evaluable negative venogram for proximal DVT in both legs or a positive venogram for proximal DVT in either leg or confirmed symptomatic proximal DVT, PE or death related to VTE during the treatment period.)
ParticipantsNUMBER
SECONDARYNumber of Participants With Proximal Deep Vein Thrombosis During Treatment Period28-35 days
Full Analysis Set - pDVT (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery (i.e. a date of surgery was reported), evaluable negative venogram for proximal DVT in both legs or positive venogram in either leg or confirmed symptomatic proximal DVT)
ParticipantsNUMBER
SECONDARYNumber of Participants With Total Deep Vein Thrombosis During Treatment Period28-35 days
Full Analysis Set-tDVT (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, evaluable negative venogram for both distal and proximal DVT in both legs or positive venography in any 1 segment of 1 or both legs, or confirmed symptomatic DVT.)
ParticipantsNUMBER
SECONDARYNumber of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period28-35 daysFull Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported)ParticipantsNUMBER
SECONDARYNumber of Participants With Pulmonary Embolism During Treatment Period28-35 daysFull Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported)ParticipantsNUMBER
SECONDARYNumber of Participants Who Died During Treatment Period28-35 daysFull Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported)ParticipantsNUMBER
SECONDARYNumber of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period3 monthsPatients with any data available during follow-upParticipantsNUMBER
SECONDARYNumber of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period28-35 daysAll patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication.ParticipantsNUMBER
SECONDARYBlood TransfusionDay 1Treated and operated patientsparticipantsNUMBER
SECONDARYVolume of Blood LossDay 1Treated and operated patientsmLMEAN
SECONDARYLaboratory AnalysesFirst administration to end of studyTreated patientsparticipantsNUMBER

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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