Trial · NCT02585713
Apixaban or Dalteparin in Reducing Blood Clots in Patients With Cancer Related Venous Thromboembolism
NCT02585713, Phase 3, Completed, Academic and Community Cancer Research United; results first posted 2019-12-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Apixaban or Dalteparin in Reducing Blood Clots in Patients With Cancer Related Venous Thromboembolism. Trials, record NCT02585713. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02585713
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Apixaban or Dalteparin in Reducing Blood Clots in Patients With Cancer Related Venous Thromboembolism
- NCT number
- NCT02585713
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 300 participants, actual
- Lead sponsor
- Academic and Community Cancer Research United
- Conditions
Cerebral Vein Thrombosis, Deep Vein Thrombosis, Gonadal Thrombosis, Hepatic Thrombosis, Malignant Neoplasm, Mesenteric Thrombosis, Metastatic Malignant Neoplasm, Portal Vein Thrombosis, Pulmonary Embolism, Renal Vein Thrombosis, Splenic Thrombosis, Venous Thromboembolism
- Interventions
- Apixaban, Dalteparin, Questionnaire Administration
- First posted
- 2015-10-23
- Last updated
- 2020-08-04
- Results first posted
- 2019-12-24
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 6 Month Bleeding Rate | Up to 6 months | The rate (percentage) of patients experiencing major bleeding at 6 months from treatment initiation and its associated 95% confidence interval was estimated separately by treatment arm using a cumulative incidence function, treating death without bleeding as a competing risk. |
| Secondary | Composite Bleeding Rate: Major Bleed or a Clinically Relevant Non-major Bleed | Up to 6 months | A similar analysis as described for the primary safety analysis will be used. The rate (percentage) of patients experiencing major bleeding or a clinically relevant non-major bleed at 6 months from treatment initiation and its associated 95% confidence interval was estimated separately by treatment arm using a cumulative incidence function, treating death without bleeding as a competing risk. |
| Secondary | Time to the First Event of the Composite Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE) | Up to 3 months post-treatment | Analyzed using the same methods described above for the primary endpoint.Time to the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE) is defined as the time from randomization to the date the patient experienced the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 6 Month Bleeding Rate | Up to 6 months | Primary Analysis Population | percentage of patients | NUMBER |
| SECONDARY | Composite Bleeding Rate: Major Bleed or a Clinically Relevant Non-major Bleed | Up to 6 months | percentage of patients | NUMBER | |
| SECONDARY | Time to the First Event of the Composite Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE) | Up to 3 months post-treatment | months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 6 Month Bleeding Rate | Arm A (Apixaban) | 0 | 95% Confidence Interval 0 to 0 | percentage of patients | |
| 6 Month Bleeding Rate | Arm B (Dalteparin) | 2.1 | 95% Confidence Interval 0.6 to 6.6 | percentage of patients | |
| Composite Bleeding Rate: Major Bleed or a Clinically Relevant Non-major Bleed | Arm A (Apixaban) | 7.0 | 95% Confidence Interval 4.1 to 11.9 | percentage of patients | |
| Composite Bleeding Rate: Major Bleed or a Clinically Relevant Non-major Bleed | Arm B (Dalteparin) | 8.1 | 95% Confidence Interval 4.7 to 13.9 | percentage of patients | |
| Time to the First Event of the Composite Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE) | Arm A (Apixaban) | NA | 95% Confidence Interval NA to NA | months | |
| Time to the First Event of the Composite Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE) | Arm B (Dalteparin) | NA | 95% Confidence Interval NA to NA | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Apixaban) | 150 | |
| Overall Study | STARTED | Arm B (Dalteparin) | 150 | |
| Overall Study | COMPLETED | Arm A (Apixaban) | 145 | |
| Overall Study | COMPLETED | Arm B (Dalteparin) | 142 | |
| Overall Study | NOT COMPLETED | Arm A (Apixaban) | 5 | |
| Overall Study | NOT COMPLETED | Arm B (Dalteparin) | 8 |
Source ClinicalTrials.gov
Adverse events394
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Arm A (Apixaban) | 14 | 148 | 28 |
| other | Anemia | Blood and lymphatic system disorders | Arm B (Dalteparin) | 12 | 143 | 22 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm A (Apixaban) | 0 | 148 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm B (Dalteparin) | 2 | 143 | 2 |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Arm A (Apixaban) | 0 | 148 | 0 |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Arm B (Dalteparin) | 1 | 143 | 1 |
| other | Chest pain - cardiac | Cardiac disorders | Arm A (Apixaban) | 1 | 148 | 1 |
| other | Chest pain - cardiac | Cardiac disorders | Arm B (Dalteparin) | 0 | 143 | 0 |
| other | Conduction disorder | Cardiac disorders | Arm A (Apixaban) | 0 | 148 | 0 |
| other | Conduction disorder | Cardiac disorders | Arm B (Dalteparin) | 1 | 143 | 1 |
1 to 10 of 394Source ClinicalTrials.gov
See all 394 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Apixaban) | 35 | 148 |
| Total, all-cause mortality | Arm B (Dalteparin) | 25 | 143 |
| Total, other adverse events | Arm A (Apixaban) | 78 | 148 |
| Total, other adverse events | Arm B (Dalteparin) | 71 | 143 |
| Total, serious adverse events | Arm A (Apixaban) | 62 | 148 |
| Total, serious adverse events | Arm B (Dalteparin) | 51 | 143 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (Apixaban) vs Arm B (Dalteparin): deaths from any cause | Trial comparisons |
| Arm A (Apixaban) vs Arm B (Dalteparin): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02585713
GET https://conductscience.org/api/trials/v1/NCT02585713/events?page=2