Trial · NCT00643201
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment | Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early) | All randomized participants with a non-missing primary endpoint (n/N: 59/2609; 71/2635, in apixaban, enoxaparin/warfarin, respectively). Intent-to-treat population. Confidence interval (CI) for event rate calculated based on the Wald asymptotic confidence limits. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death | Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early) | All randomized participants with non-missing secondary endpoint (n/N: 84/2609; 104/2635, in apixaban, enoxaparin/warfarin arms, respectively). Participants categorized to assigned arm, regardless of treatment actually received. Intent to Treat principle. Confidence interval (CI) for event rate calculated based on Wald asymptotic confidence limits. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death | Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early) | All randomized participants with non-missing secondary endpoint (n/N: 61/2609; 77/2635, in apixaban, enoxaparin/warfarin arms, respectively). Participants categorized to assigned arm, regardless of treatment actually received. Intent to Treat principle. CI for event rate calculated based on Wald asymptotic confidence limits. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding | Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early) | Total number of participants in each randomized arm, excluded those with missing endpoint and included those not in the efficacy evaluable population with bleeding event which occurred during treatment (n/N: 73/2610; 118/2635). Confidence interval (CI) for event rate calculated based on Wald asymptotic confidence limits. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding | Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early) | Total number participants in each treatment group, excluded those with missing endpoint and included those not in the efficacy evaluable population with bleeding event which occurred during treatment (n/N: 183/2617; 333/2641). Events included as per ITT principle. CI for event rate calculated based on Wald asymptotic confidence limits. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period | Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early) | Total number of participants in each randomized arm (ITT), excluding those with missing endpoint (n/N: 22/2608; 35/2633). CI for event rate calculated based on Wald asymptotic confidence limits. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Adjudicated Symptomatic Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period | Day 1 to Week 24 + + 2 Days or 355 Days (Discontinued Early) | Total number of participants in each randomized arm (ITT), excluding those with missing endpoint (n/N: 27/2606; 25/2632). CI for event rate calculated based on Wald asymptotic confidence limits. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Adjudicated Venous Thromboembolism (VTE)-Related Death During the Intended Treatment Period | Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) | Total number of participants in respective treatment groups excluding participants with missing endpoint information. (n/N: 12/2608; 16/2630). CI for event rate calculated based on Wald asymptotic confidence limits. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Cardiovascular (CV)-Related Death Including VTE-related Death During the Intended Treatment Period | Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) | Total number of participants in respective groups excluding those with missing endpoint information (n/N: 15/2608; 23/2630). CI for event rate calculated based on Wald asymptotic confidence limits. | proportion of participants | NUMBER |
| SECONDARY | Incidence of All-Cause Death During the Intended Treatment Period | Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) | Total number of participants excluding those with missing endpoint (n/N: 41/2608; 52/2630). Events included regardless of whether or not participant received treatment, ie, ITT principle. CI for event rate calculated based on Wald asymptotic confidence limits. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Adjudicated Major Bleeding During the Treatment Period in Treated Participants | Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) | Total number of participants receiving at least one dose of study drug n/N: 15/2676; 49/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Adjudicated Major/CRNM Bleeding During the Treatment Period in Treated Participants | Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) | Total number of participants receiving at least one dose of study drug n/N: 115/2676; 261/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Adjudicated Clinically Relevant Non Major (CRNM) Bleeding During the Treatment Period in Treated Participants | Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) | Total number of participants receiving at least one dose of study drug n/N: 103/2676; 215/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Adjudicated Minor Bleeding During the Treatment Period in Treated Participants | Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) | Total number of participants receiving at least one dose of study drug n/N: 313/2676; 505/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Adjudicated Total Bleeding During the Treatment Period in Treated Participants | Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) | Total number of participants receiving at least one dose of study drug n/N: 402/2676; 676/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received. | proportion of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Discontinuations Due to AEs and Death During the Treatment Period in Treated Participants | First dose to last dose of 24 Weeks + 2 days (AEs) or + 30 days (SAEs) or until drug discontinued | Total number of participants receiving at least one dose of study drug. Participants were categorized according to the actual treatment received. | participants | NUMBER |
| SECONDARY | Number of Treated Participants With Marked Abnormalities in Hematology Laboratory Tests | Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) | N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements. | participants | NUMBER |
| SECONDARY | Number of Treated Participants With Marked Abnormalities in Electrolyte Laboratory Tests | Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) | N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements. | participants | NUMBER |
| SECONDARY | Number of Treated Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests | Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) | N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements. | participants | NUMBER |
| SECONDARY | Number of Treated Participants With Marked Abnormalities in Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests | Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) | N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements. | participants | NUMBER |
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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