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To collect postmarketing data about Fragmin safety and efficacy in the treatment of deep vein thrombosis with or without pulmonary embolism in cancer patients.
Method: consecutive patient sampling. Patients were (are) included in the study in consecutive manner if they fulfilled the inclusion criteria and any of the exclusion criteria were not present.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One cohort of patients treated with dalteparin. | About 100 patients with deep-vein thrombosis and with or without pulmonary embolism will be included in the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fragmin (dalteparin sodium ) | Drug | Month 1: dalteparin 200 IU/kg SC once daily. Months 2-6: dalteparin 150 IU/kg SC, once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg | Resolution criteria: clinical cure, defined as negative results of a compressive ultrasound examination of the leg | Month 6 or End of Treatment (EOT) (up to Month 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The patients are identified in primary care setting.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dalteparin | Dalteparin 200 International Units per kilogram (IU/kg) total body weight subcutaneously (SC) once daily (QD) for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dalteparin | Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg | Resolution criteria: clinical cure, defined as negative results of a compressive ultrasound examination of the leg | 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. | Posted | Number | Participants | Month 6 or End of Treatment (EOT) (up to Month 6) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dalteparin | Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiopulmonary failure | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D017985 | Dalteparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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|
| Baseline through Month 6 or EOT (up to Month 6) |
| Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL) | 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. | Baseline through Month 6 or EOT (up to Month 6) |
| Percent of Participants With and Without Pulmonary Embolism (PE) | PE (diagnosed on the basis of ventilation-perfusion scan of the lungs or autopsy) | Baseline, Week 2, Month 1, Month 3, and Month 6 or EOT (up to Month 6) |
| Number of Participants With Recurrent DVT | 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 | Month 6 or EOT (up to Month 6) |
| Lost to follow-up; subsequently died |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood | 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. | The safety analysis set was defined as all participants who received at least 1 dose of study treatment. | Posted | Number | Participants | Baseline through Month 6 or EOT (up to Month 6) |
|
|
|
| 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) | 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. | Safety analysis set. | Posted | Number | Participants | Baseline through Month 6 or EOT (up to Month 6) |
|
|
|
| Secondary | Percent of Participants With and Without Pulmonary Embolism (PE) | PE (diagnosed on the basis of ventilation-perfusion scan of the lungs or autopsy) | FAS. n = number of participants per PE status at observation. | Posted | Number | Percent of participants | Baseline, Week 2, Month 1, Month 3, and Month 6 or EOT (up to Month 6) |
|
|
|
| Secondary | Number of Participants With Recurrent DVT | 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 | FAS | Posted | Number | Participants | Month 6 or EOT (up to Month 6) |
|
|
|
| 13 |
| 102 |
| 0 |
| 102 |
| Disease progression | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D002241 |
| Carbohydrates |
| Title | Measurements |
|---|---|
|
| Week 2 with PE (n = 7) |
|
| Week 2 without PE (n = 85) |
|
| Week 2 with missing information (n = 10) |
|
| Month 1 with PE (n = 3) |
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| Month 1 without PE (n = 96) |
|
| Month 1 with missing information (n = 3) |
|
| Month 3 with PE (n = 1) |
|
| Month 3 without PE (n = 91) |
|
| Month 3 with missing information (n = 10) |
|
| Month 6 or EOT with PE (n = 3) |
|
| Month 6 or EOT without PE (n = 85) |
|
| Month 6 or EOT with missing information (n = 14) |
|