Acute Deep Vein Thrombosis
Conditions
Brief summary
To collect postmarketing data about Fragmin safety and efficacy in the treatment of deep vein thrombosis with or without pulmonary embolism in cancer patients.
Detailed description
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.
Interventions
DRUGFragmin (dalteparin sodium )
Month 1: dalteparin 200 IU/kg SC once daily. Months 2-6: dalteparin 150 IU/kg SC, once daily.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patient of 18 - 70 years of age. * Cancer patient with proven deep-vein thrombosis with or without pulmonary embolism confirmed by combination of clinical signs and symptoms, pulmonary hypertension on echocardiogram, X-ray examination of the lung and eventually perfusion/ventilation scan of the lung.
Exclusion criteria
* Bleeding * Hypersensitivity to FRAGMIN® or other low-molecular weight heparins. * Serum creatinine level \> 150 umol/l. * Platelet count of less than 100 000 per cubic millimeter at the beginning of the therapy. * Patient on oral anticoagulation therapy in the last 7 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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) |
| 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 102 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 12 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Lost to follow-up; subsequently died | 1 |
| Overall Study | Other | 2 |
Baseline characteristics
| Characteristic | Dalteparin |
|---|---|
| Age Continuous | 61.6 years STANDARD_DEVIATION 10.1 |
| Age, Customized >= 65 years | 39 Participants |
| Age, Customized Between 18 and 44 years | 4 Participants |
| Age, Customized Between 45 and 64 years | 58 Participants |
| Age, Customized Unspecified | 1 Participants |
| Sex: Female, Male Female | 54 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 102 |
| serious Total, serious adverse events | 13 / 102 |
Outcome results
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
Time frame: Month 6 or End of Treatment (EOT) (up to Month 6)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dalteparin | Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg | 43 Participants |
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
Time frame: Month 6 or EOT (up to Month 6)
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dalteparin | Number of Participants With Recurrent DVT | 3 Participants |
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.
Time frame: Baseline through Month 6 or EOT (up to Month 6)
Population: Safety analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dalteparin | Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL) | 0 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.
Time frame: Baseline through Month 6 or EOT (up to Month 6)
Population: The safety analysis set was defined as all participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dalteparin | Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood | 0 Participants |
Secondary
Percent of Participants With and Without Pulmonary Embolism (PE)
PE (diagnosed on the basis of ventilation-perfusion scan of the lungs or autopsy)
Time frame: Baseline, Week 2, Month 1, Month 3, and Month 6 or EOT (up to Month 6)
Population: FAS. n = number of participants per PE status at observation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalteparin | Percent of Participants With and Without Pulmonary Embolism (PE) | Baseline with PE (n = 16) | 15.7 Percent of participants |
| Dalteparin | Percent of Participants With and Without Pulmonary Embolism (PE) | Baseline without PE (n = 82) | 80.4 Percent of participants |
| Dalteparin | Percent of Participants With and Without Pulmonary Embolism (PE) | Baseline with missing information (n = 4) | 3.9 Percent of participants |
| Dalteparin | Percent of Participants With and Without Pulmonary Embolism (PE) | Week 2 with PE (n = 7) | 6.9 Percent of participants |
| Dalteparin | Percent of Participants With and Without Pulmonary Embolism (PE) | Week 2 without PE (n = 85) | 83.3 Percent of participants |
| Dalteparin | Percent of Participants With and Without Pulmonary Embolism (PE) | Week 2 with missing information (n = 10) | 9.8 Percent of participants |
| Dalteparin | Percent of Participants With and Without Pulmonary Embolism (PE) | Month 1 with PE (n = 3) | 2.9 Percent of participants |
| Dalteparin | Percent of Participants With and Without Pulmonary Embolism (PE) | Month 1 without PE (n = 96) | 94.1 Percent of participants |
| Dalteparin | Percent of Participants With and Without Pulmonary Embolism (PE) | Month 1 with missing information (n = 3) | 2.9 Percent of participants |
| Dalteparin | Percent of Participants With and Without Pulmonary Embolism (PE) | Month 3 with PE (n = 1) | 1.0 Percent of participants |
| Dalteparin | Percent of Participants With and Without Pulmonary Embolism (PE) | Month 3 without PE (n = 91) | 89.2 Percent of participants |
| Dalteparin | Percent of Participants With and Without Pulmonary Embolism (PE) | Month 3 with missing information (n = 10) | 9.8 Percent of participants |
| Dalteparin | Percent of Participants With and Without Pulmonary Embolism (PE) | Month 6 or EOT with PE (n = 3) | 2.9 Percent of participants |
| Dalteparin | Percent of Participants With and Without Pulmonary Embolism (PE) | Month 6 or EOT without PE (n = 85) | 83.3 Percent of participants |
| Dalteparin | Percent of Participants With and Without Pulmonary Embolism (PE) | Month 6 or EOT with missing information (n = 14) | 13.7 Percent of participants |