Trial · NCT00480636
Fragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients
NCT00480636, Completed, Pfizer; results first posted 2010-08-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients. Trials, record NCT00480636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00480636
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients
- NCT number
- NCT00480636
- Status
- Completed
- Enrollment
- 102 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Acute Deep Vein Thrombosis
- Interventions
- Fragmin (dalteparin sodium )
- First posted
- 2007-05-31
- Last updated
- 2010-08-10
- Results first posted
- 2010-08-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg | Month 6 or End of Treatment (EOT) (up to Month 6) | Resolution criteria: clinical cure, defined as negative results of a compressive ultrasound examination of the leg |
| Secondary | Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood | Baseline through Month 6 or EOT (up to Month 6) | Episodes of the severe bleeding (intracranial, intraspinal, intraocular, retroperitoneal, or in pericardial area) or bleeding from gastrointestinal (GIT), urinary system or gynecological bleeding resulted in a need for a transfusion of at least 2 units of blood. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment. |
| Secondary | Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL) | Baseline through Month 6 or EOT (up to Month 6) | Episodes of the severe bleeding (intracranial, intraspinal, intraocular, retroperitoneal, or in pericardial area) or bleeding from GIT, urinary system or gynecological bleeding which led to a drop of hemoglobin of at least 2.0 g/dL. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment. |
| Secondary | Percent of Participants With and Without Pulmonary Embolism (PE) | Baseline, Week 2, Month 1, Month 3, and Month 6 or EOT (up to Month 6) | PE (diagnosed on the basis of ventilation-perfusion scan of the lungs or autopsy) |
| Secondary | Number of Participants With Recurrent DVT | Month 6 or EOT (up to Month 6) | Defined as the number of participants with recurrence of DVT (diagnosed using compressive ultrasound examination or autopsy) after it has resolved (at the same location) or occurrence of new DVT at a new location on any of the post-baseline visits |
Source ClinicalTrials.gov
Outcomes5
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 Resolution of Deep Vein Thrombosis (DVT) of the Leg | Month 6 or End of Treatment (EOT) (up to Month 6) | Full analysis set (FAS): all participants who received at least 1 dose of the study treatment and who had at least 1 post baseline efficacy measurement. | Participants | NUMBER |
| SECONDARY | Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood | Baseline through Month 6 or EOT (up to Month 6) | The safety analysis set was defined as all participants who received at least 1 dose of study treatment. | Participants | NUMBER |
| SECONDARY | Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL) | Baseline through Month 6 or EOT (up to Month 6) | Safety analysis set. | Participants | NUMBER |
| SECONDARY | Percent of Participants With and Without Pulmonary Embolism (PE) | Baseline, Week 2, Month 1, Month 3, and Month 6 or EOT (up to Month 6) | FAS. n = number of participants per PE status at observation. | Percent of participants | NUMBER |
| SECONDARY | Number of Participants With Recurrent DVT | Month 6 or EOT (up to Month 6) | FAS | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group19
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 Resolution of Deep Vein Thrombosis (DVT) of the Leg | Dalteparin | 43 | Participants | ||
| Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood | Dalteparin | 0 | Participants | ||
| Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL) | Dalteparin | 0 | Participants | ||
| Percent of Participants With and Without Pulmonary Embolism (PE) | Dalteparin | Baseline with PE (n = 16) | 15.7 | Percent of participants | |
| Percent of Participants With and Without Pulmonary Embolism (PE) | Dalteparin | Baseline without PE (n = 82) | 80.4 | Percent of participants | |
| Percent of Participants With and Without Pulmonary Embolism (PE) | Dalteparin | Baseline with missing information (n = 4) | 3.9 | Percent of participants | |
| Percent of Participants With and Without Pulmonary Embolism (PE) | Dalteparin | Week 2 with PE (n = 7) | 6.9 | Percent of participants | |
| Percent of Participants With and Without Pulmonary Embolism (PE) | Dalteparin | Week 2 without PE (n = 85) | 83.3 | Percent of participants | |
| Percent of Participants With and Without Pulmonary Embolism (PE) | Dalteparin | Week 2 with missing information (n = 10) | 9.8 | Percent of participants | |
| Percent of Participants With and Without Pulmonary Embolism (PE) | Dalteparin | Month 1 with PE (n = 3) | 2.9 | Percent of participants |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dalteparin | 102 | |
| Overall Study | COMPLETED | Dalteparin | 83 | |
| Overall Study | NOT COMPLETED | Dalteparin | 19 |
Source ClinicalTrials.gov
Adverse events7
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 |
|---|---|---|---|---|---|---|
| serious | Cardiopulmonary failure | Cardiac disorders | Dalteparin | 2 | 102 | |
| serious | Disease progression | General disorders | Dalteparin | 9 | 102 | |
| serious | Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Dalteparin | 1 | 102 | |
| serious | Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Dalteparin | 1 | 102 | |
| serious | Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Dalteparin | 1 | 102 | |
| serious | Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Dalteparin | 1 | 102 | |
| serious | Embolism | Vascular disorders | Dalteparin | 1 | 102 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dalteparin | ||
| Total, other adverse events | Dalteparin | 0 | 102 |
| Total, serious adverse events | Dalteparin | 13 | 102 |
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/NCT00480636
GET https://conductscience.org/api/trials/v1/NCT00480636/registered