Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
Trial · NCT00371683
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event Rate of the Composite of Adjudicated Venous Thromboembolism (VTE) Events and All-Cause Death With Onset During the Intended Treatment Period - Primary Subjects | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | Primary Population=All randomized participants who: have an adjudicated and evaluable bilateral venogram performed during the Intended Treatment Period; or have an adjudicated VTE during the Intended Treatment Period; or die due to any cause during the Intended Treatment Period. | percentage of participants | NUMBER |
| SECONDARY | Event Rate of Composite of Adjudicated Proximal DVT, Non-Fatal PE and All-Cause Death With Onset During the Intended Treatment Period PE and All-cause Death During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated non-fatal PE or death, during the Intended Treatment Period, were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Event Rate of Adjudicated VTE / VTE-related Death With Onset During the Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | Randomized participants with an adjudicated and evaluable bilateral venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Event Rate for Participants With Proximal DVT/Non-Fatal PE/ VTE-Related Death With Onset During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Event Rate for Total Participants With Adjudicated VTE/All-Cause Death With Onset During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Event Rate for Total Participants With VTE/ VTE-Related Death With Onset During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Event Rate for Participants With All-Cause Death During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | All Randomized participants were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Event Rate for Participants With VTE-Related Death With Onset During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | All randomized participants were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Event Rate for Participants With Symptomatic VTE/ All-Cause Death With Onset During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | All randomized participants were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Event Rate for Participants With Symptomatic VTE/ VTE-Related Death With Onset During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | All randomized participants were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Event Rate for Participants With VTE/Major Bleeding/All-Cause Death With Onset During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | Randomized participants with an adjudicated and evaluable bilateral venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Event Rate for Participants With PE (Fatal or Non-Fatal), DVT (All, Symptomatic Proximal, and Distal, Asymptomatic) With Onset During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | All randomized participants: PE, Symptomatic DVT, Symptomatic Proximal DVT, Symptomatic Distal DVT. Randomized with an adjudicated and evaluable bilateral venogram or an adjudicated event associated with the endpoint: All DVT, Asymptomatic DVT. n=number analyzed in each category | percentage of participants | NUMBER |
| SECONDARY | Event Rate for Participants With Proximal DVT, Distal DVT, Asymptomatic Proximal DVT, Asymptomatic Distal DVT With Onset During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | Randomized participants with either an adjudicated and evaluable bilateral proximal (or distal, as appropriate) venogram or an adjudicated event associated with the endpoint. n= number analyzed | percentage of participants | NUMBER |
| SECONDARY | Event Rate for Participants With Adjudicated Myocardial Infarction (MI) Acute Ischemic Stroke and Thromboembolic Events With Onset During the Treatment Period | From first dose to last dose, plus 2 days (12 days, plus 2) | All participants who received at least one dose of study drug were analyzed (Treated Population). | percentage of participants | NUMBER |
| PRIMARY | Event Rate for Participants With Major Bleeding, Clinically Relevant Non-Major Bleeding, Major or Clinically Relevant Non-Major Bleeding, Any Bleeding With Onset During the Treatment Period - Treated Population | First dose of study drug to last dose, plus 2 days post last dose | All participants who received at least one dose of study drug (Treated population). | percentage of participants | NUMBER |
| PRIMARY | Event Rate for Participants With Major Bleeding, Clinically Relevant (CR) Non-Major (N-M) Bleeding , Major or Clinically Relevant (CR) Non-Major (N-M) Bleeding, Any Bleeding With Onset During the Follow-Up Period | Last dose of study drug to Day 72 (60 days) | All participants who received at least 1 dose of study drug during the Treatment Period and entered the Follow-Up Period. | percentage of participants | NUMBER |
| SECONDARY | Event Rate of Adjudicated MI, Stroke, and Thrombocytopenia Events During the Follow-Up Period | Post last dose of study drug to Day 72 (60 days) | Participants who received at least one dose of study drug and entered the Follow-Up period | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), AEs Leading to Discontinuation, and Deaths - Treated Population | First dose to last dose, plus 2 days for AEs (12 + 2 days) or plus 30 days for SAEs (12 + 30 days) | All participants who received at least 1 dose of study drug during the Treatment Period. | participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | Baseline to last dose of study drug, plus 2 days | All participants who received at least one dose of study drug and had blood pressure measurements at baseline were summarized. | mmHg | MEAN |
| SECONDARY | Mean Change From Baseline in Heart Rate During the Treatment Period | Baseline to last dose of study drug, plus 2 days | All participants who received at least one dose of study drug and had heart rate measurements at baseline were summarized. | bpm | MEAN |
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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