Trial · NCT02073682
Cancer Venous Thromboembolism (VTE)
NCT02073682, Phase 3, Completed, Daiichi Sankyo; results first posted 2018-10-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cancer Venous Thromboembolism (VTE). Trials, record NCT02073682. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02073682
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cancer Venous Thromboembolism (VTE)
- NCT number
- NCT02073682
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,046 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Venous Thromboembolism (VTE), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Cancer
- Interventions
- Edoxaban, Dalteparin, Low molecular weight heparin
- First posted
- 2014-02-27
- Last updated
- 2019-03-06
- Other registries' IDs
- eudract:2014-004708-30
- Results first posted
- 2018-10-24
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event | 12 months | |
| Secondary | Number of Participants With Adjudicated Major Bleeding Events While on Treatment | 12 months | The primary safety endpoint was major bleeding events during the On-Treatment Study Period (defined as on-study drug or up to 3 days after the last dose of study drug). |
| Secondary | Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period | 12 months | |
| Secondary | Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period | 12 months | |
| Secondary | Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period | 12 months | |
| Secondary | Number of Participants With VTE-Related Death | 12 months | |
| Secondary | Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death | 12 months |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event | 12 months | modified Intent to Treat (mITT), equating to the Safety Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adjudicated Major Bleeding Events While on Treatment | 12 months | Safety analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period | 12 months | mITT (Safety Analysis Set) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period | 12 months | mITT (Safety Analysis Set) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period | 12 months | mITT (Safety Analysis Set) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With VTE-Related Death | 12 months | mITT (Safety Analysis Set) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death | 12 months | mITT (Safety Analysis Set) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event | Edoxaban Group | 67 | Participants | ||
| Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event | Dalteparin Group | 71 | Participants | ||
| Number of Participants With Adjudicated Major Bleeding Events While on Treatment | Edoxaban Group | 32 | Participants | ||
| Number of Participants With Adjudicated Major Bleeding Events While on Treatment | Dalteparin Group | 16 | Participants | ||
| Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period | Edoxaban Group | 41 | Participants | ||
| Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period | Dalteparin Group | 59 | Participants | ||
| Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period | Edoxaban Group | 19 | Participants | ||
| Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period | Dalteparin Group | 35 | Participants | ||
| Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period | Edoxaban Group | 21 | Participants | ||
| Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period | Dalteparin Group | 24 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Edoxaban Group | 522 | |
| Overall Study | STARTED | Dalteparin Group | 524 | |
| Overall Study | COMPLETED | Edoxaban Group | 200 | |
| Overall Study | COMPLETED | Dalteparin Group | 154 | |
| Overall Study | NOT COMPLETED | Edoxaban Group | 322 | |
| Overall Study | NOT COMPLETED | Dalteparin Group | 370 |
Source ClinicalTrials.gov
Adverse events498
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 | Deep vein thrombosis | Vascular disorders | Edoxaban Group | 34 | 522 | 40 |
| other | Deep vein thrombosis | Vascular disorders | Dalteparin Group | 37 | 524 | 45 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Edoxaban Group | 41 | 522 | 44 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Dalteparin Group | 30 | 524 | 42 |
| serious | Anaemia | Blood and lymphatic system disorders | Edoxaban Group | 4 | 522 | 4 |
| serious | Anaemia | Blood and lymphatic system disorders | Dalteparin Group | 2 | 524 | 2 |
| serious | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Edoxaban Group | 0 | 522 | 0 |
| serious | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Dalteparin Group | 1 | 524 | 1 |
| serious | Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | Edoxaban Group | 0 | 522 | 0 |
| serious | Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | Dalteparin Group | 4 | 524 | 4 |
1 to 10 of 498Source ClinicalTrials.gov
See all 498 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Edoxaban Group | 206 | 522 |
| Total, all-cause mortality | Dalteparin Group | 192 | 524 |
| Total, other adverse events | Edoxaban Group | 75 | 522 |
| Total, other adverse events | Dalteparin Group | 67 | 524 |
| Total, serious adverse events | Edoxaban Group | 276 | 522 |
| Total, serious adverse events | Dalteparin Group | 251 | 524 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Edoxaban Group vs Dalteparin Group: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event | Trial comparisons |
| Edoxaban Group vs Dalteparin Group: Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death | Trial comparisons |
| Edoxaban Group vs Dalteparin Group: Number of Participants With Adjudicated Major Bleeding Events While on Treatment | Trial comparisons |
| Edoxaban Group vs Dalteparin Group: Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period | Trial comparisons |
| Edoxaban Group vs Dalteparin Group: Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period | Trial comparisons |
| Edoxaban Group vs Dalteparin Group: Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period | Trial comparisons |
| Edoxaban Group vs Dalteparin Group: deaths from any cause | Trial comparisons |
| Edoxaban Group vs Dalteparin Group: Number of Participants With VTE-Related Death | Trial comparisons |
| Edoxaban Group vs Dalteparin Group: 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/NCT02073682
GET https://conductscience.org/api/trials/v1/NCT02073682/events?page=2