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Trial · NCT00423319

Outcomes14

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARY
Rate of Composite of Adjudicated Venous Thromboembolic Event (VTE)-Related (Pulmonary Embolism and Symptomatic and Asymptomatic Deep Vein Thrombosis[DVT]) and All-cause Death During the Intended Treatment Period
Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first doseAll randomized participants who, during the Intended Treatment Period, had an adjudicated and evaluable bilateral venogram, had an adjudicated venous thromboembolic event, or died of any cause.Percentage of events/patients evaluatedNUMBER
SECONDARYRate of Composite of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During Intended Treatment PeriodDay 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first doseRandomized participants with either an adjudicated event or an adjudicated evaluable bilateral venogramPercentage of events/patients evaluatedNUMBER
SECONDARY
Rates of Adjudicated All-cause Death, VTE-related Death, Pulmonary Embolism (PE), Nonfatal PE, Deep Vein Thrombosis (DVT) (Symptomatic and Asymptomatic), Symptomatic and Asymptomatic Proximal and Distal DVT During the Intended Treatment Period
Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first doseAll participants randomized to treatmentPercentage of events/patients evaluatedNUMBER
SECONDARYRate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), Major or CRNM, and Any Bleeding During the Treatment PeriodFirst dose of study drug (presurgery) through 2 days after the last dose of study drugAll participants who received at least 1 dose of study drugPercentage of events/patients evalutedNUMBER
SECONDARYNumber of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), and Death as OutcomeFirst dose of study drug (presurgery) through 30 days after the last dose of study drugAll participants who received at least 1 dose of study medicationParticipantsNUMBER
SECONDARYNumber of Participants With a Bleeding-related Adverse Event During the Treatment PeriodFirst dose of study drug (presurgery) through 2 days after the last dose of study drugAll participants who received at least 1 dose of study drugParticipantsNUMBER
SECONDARYNumber of Participants With a Bleeding-related Adverse Events During the Treatment Period (Continued)First dose of study drug (presurgery) through 2 days after the last dose of study drugAll participants who received at least 1 dose of study drugParticipantsNUMBER
SECONDARYNumber of Participants With a Bleeding-related Adverse Event During the Treatment Period (Continued)First dose of study drug (presurgery) through 2 days after the last dose of study drugAll participants who received at least 1 dose of study drugParticipantsNUMBER
SECONDARYNumber of Participants With Neurologic Adverse Events With Onset During the Treatment PeriodFirst dose of study drug (presurgery) through 2 days after the last dose of study drugAll participants who received at least 1 dose of study drugParticipantsNUMBER
SECONDARYNumber of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment PeriodFirst dose of study drug (presurgery) through 2 days after the last dose of study drugAll participants who received at least 1 dose of study drugParticipantsNUMBER
SECONDARYNumber of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)First dose of study drug (presurgery) through 2 days after the last dose of study drugAll participants who received at least 1 dose of study drugParticipantsNUMBER
SECONDARYNumber of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)First dose of study drug (presurgery) through 2 days after the last dose of study drugAll participants who received at least 1 dose of study drugParticipantsNUMBER
SECONDARYNumber of Participants With Adverse Events Related to Elevations in Liver Function Test Results With Onset During the Treatment PeriodFirst dose of study drug (presurgery) through 30 days after the last dose of study drugAll participants who received at least 1 dose of study drugParticipantsNUMBER
SECONDARYRates of Adjudicated Myocardial Infarction (MI)/Stroke, MI, Stroke, and Thrombocytopenia During the Intended Treatment PeriodDay 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first doseAll participants who received at least 1 dose of study drugPercent of events/patients evaluatedNUMBER

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone 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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