Trial · NCT00942968
Evaluation of Dalteparin for Long-term (One Year) Treatment of Blood Clots in Subjects With Cancer
NCT00942968, Phase 4, Completed, Pfizer; results first posted 2017-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Dalteparin for Long-term (One Year) Treatment of Blood Clots in Subjects With Cancer. Trials, record NCT00942968. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00942968
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Dalteparin for Long-term (One Year) Treatment of Blood Clots in Subjects With Cancer
- NCT number
- NCT00942968
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 338 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Cancer
- Interventions
- dalteparin
- First posted
- 2009-07-21
- Last updated
- 2024-04-18
- Results first posted
- 2017-02-24
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee | Month 2 up to Month 6 | A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of greater than or equal to (\>=) 2 gram per deciliter (g/dL), 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. In this outcome measure, number of participants with major bleeding events (adjudicated by Central Adjudication Committee) were reported. |
| Primary | Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee | Month 7 up to Month 12 | A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of \>=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. In this outcome measure, number of participants with major bleeding events (adjudicated by Central Adjudication Committee) were reported. |
| Primary | Number of Participants With New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee | Month 7 up to Month 12 | VTEs included both deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes pulmonary embolism (PE). When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. In this outcome measure, number of participants with new or recurrent VTE (adjudicated by Central Adjudication Committee) were reported. |
| Secondary | Number of Participants With Investigator Identified Major Bleeding Events | Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12 | A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of \>=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. In this outcome measure, number of participants with major bleeding events (identified by investigator) were reported. |
| Secondary | Number of Participants With Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee | Month 1 up to Month 6, Month 7 up to Month 12, Month 1 up to Month 12, Month 2 up to Month 6, and Month 2 up to Month 12 | A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of \>=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. A bleeding event was considered as minor if it was clinically overt but not meeting the criteria for major bleeding. In this outcome measure, number of participants with any (major or minor) bleeding events (adjudicated by Central Adjudication Committee) were reported. |
| Secondary | Number of Participants With Fatal Bleeding Events | Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12 | Fatal bleeding events refers to those bleeding events which leads to death of participant. In this outcome measure, number of participants with fatal bleeding events were reported. |
| Secondary | Time to First Occurrence of Major Bleeding Event Adjudicated by Central Adjudication Committee | Month 1 up to Month 12 | Time to first occurrence of major bleeding event was defined as the time interval (in days) between the date of first study treatment and the date of documentation of first major bleeding event. A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of \>=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. |
| Secondary | Time to First Occurrence of Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee | Month 1 up to Month 12 | Time to first occurrence of any bleeding event was defined as the time interval (in days) between the date of first study treatment and the date of documentation of first bleeding event (major or minor). A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of \>=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. A bleeding event was considered as minor if it was clinically overt but not meeting the criteria for major bleeding. |
| Secondary | Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTEs) | Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12 | VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. In this outcome measure, number of participants with new or recurrent VTE (identified by investigator) were reported. |
| Secondary | Number of Participants With New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT) Adjudicated by Central Adjudication Committee | Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12 | VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. CVT is blood clot of the venous channels in the brain. CVT was diagnosed by contrast venography or ultrasonography. In this outcome measure, number of participants with new or recurrent VTE or CVT (adjudicated by Central Adjudication Committee) were reported. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
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 Major Bleeding Events Adjudicated by Central Adjudication Committee | Month 2 up to Month 6 | Safety population included all participants who received at least 1 treatment with dalteparin sodium. | participants | NUMBER |
| PRIMARY | Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee | Month 7 up to Month 12 | Safety population included all participants who received at least one 1 treatment with dalteparin sodium. | participants | NUMBER |
| PRIMARY | Number of Participants With New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee | Month 7 up to Month 12 | Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | participants | NUMBER |
| SECONDARY | Number of Participants With Investigator Identified Major Bleeding Events | Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12 | Safety population included all participants who received at least 1 treatment with dalteparin sodium. | participants | NUMBER |
| SECONDARY | Number of Participants With Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee | Month 1 up to Month 6, Month 7 up to Month 12, Month 1 up to Month 12, Month 2 up to Month 6, and Month 2 up to Month 12 | Safety population included all participants who received at least 1 treatment with dalteparin sodium. | participants | NUMBER |
| SECONDARY | Number of Participants With Fatal Bleeding Events | Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12 | Safety population included all participants who received at least 1 treatment with dalteparin sodium. | participants | NUMBER |
| SECONDARY | Time to First Occurrence of Major Bleeding Event Adjudicated by Central Adjudication Committee | Month 1 up to Month 12 | Safety population included all participants who received at least 1 treatment with dalteparin sodium. | days | MEAN |
| SECONDARY | Time to First Occurrence of Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee | Month 1 up to Month 12 | Safety population included all participants who received at least 1 treatment with dalteparin sodium. | days | MEAN |
| SECONDARY | Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTEs) | Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12 | Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium. Here, 'n' signifies those participants who were evaluable at specified time intervals. | participants | NUMBER |
| SECONDARY | Number of Participants With New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT) Adjudicated by Central Adjudication Committee | Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12 | Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium. Here, 'n' signifies those participants who were evaluable at specified time intervals. | participants | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group163
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 Major Bleeding Events Adjudicated by Central Adjudication Committee | Dalteparin Sodium | 14 | participants | ||
| Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee | Dalteparin Sodium | 8 | participants | ||
| Number of Participants With New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee | Dalteparin Sodium | 8 | participants | ||
| Number of Participants With Investigator Identified Major Bleeding Events | Dalteparin Sodium | Month 1 up to Month 6 | 28 | participants | |
| Number of Participants With Investigator Identified Major Bleeding Events | Dalteparin Sodium | Month 7 up to Month 12 | 7 | participants | |
| Number of Participants With Investigator Identified Major Bleeding Events | Dalteparin Sodium | Month 1 up to Month 12 | 35 | participants | |
| Number of Participants With Investigator Identified Major Bleeding Events | Dalteparin Sodium | Month 2 up to Month 6 | 15 | participants | |
| Number of Participants With Investigator Identified Major Bleeding Events | Dalteparin Sodium | Month 2 up to Month 12 | 22 | participants | |
| Number of Participants With Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee | Dalteparin Sodium | Month 1 up to Month 6 | 91 | participants | |
| Number of Participants With Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee | Dalteparin Sodium | Month 7 up to Month 12 | 21 | participants |
1 to 10 of 163Source ClinicalTrials.gov
See all 163 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dalteparin Sodium | 338 | |
| Overall Study | Treated | Dalteparin Sodium | 334 | |
| Overall Study | COMPLETED | Dalteparin Sodium | 109 | |
| Overall Study | NOT COMPLETED | Dalteparin Sodium | 229 |
Source ClinicalTrials.gov
Adverse events283
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 | Injection site hematoma | General disorders | Dalteparin Sodium | 91 | 334 | |
| other | Fatigue | General disorders | Dalteparin Sodium | 90 | 334 | |
| other | Nausea | Gastrointestinal disorders | Dalteparin Sodium | 81 | 334 | |
| other | Odema peripheral | General disorders | Dalteparin Sodium | 80 | 334 | |
| other | Constipation | Gastrointestinal disorders | Dalteparin Sodium | 71 | 334 | |
| other | Diarrhea | Gastrointestinal disorders | Dalteparin Sodium | 60 | 334 | |
| other | Anemia | Blood and lymphatic system disorders | Dalteparin Sodium | 54 | 334 | |
| other | Contusion | Injury, poisoning and procedural complications | Dalteparin Sodium | 52 | 334 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Dalteparin Sodium | 52 | 334 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Dalteparin Sodium | 48 | 334 |
1 to 10 of 283Source ClinicalTrials.gov
See all 283 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dalteparin Sodium | ||
| Total, other adverse events | Dalteparin Sodium | 328 | 334 |
| Total, serious adverse events | Dalteparin Sodium | 213 | 334 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00942968
GET https://conductscience.org/api/trials/v1/NCT00942968/results?page=2