Trial Outcomes & Findings for Fragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients (NCT NCT00480636)
NCT ID: NCT00480636
Last Updated: 2010-08-10
Results Overview
Resolution criteria: clinical cure, defined as negative results of a compressive ultrasound examination of the leg
COMPLETED
102 participants
Month 6 or End of Treatment (EOT) (up to Month 6)
2010-08-10
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
83
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Death
|
12
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Other
|
2
|
|
Overall Study
Lost to follow-up; subsequently died
|
1
|
Baseline Characteristics
Fragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients
Baseline characteristics by cohort
| Measure |
Dalteparin
n=102 Participants
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.
|
|---|---|
|
Age, Customized
Between 18 and 44 years
|
4 Participants
n=5 Participants
|
|
Age, Customized
Between 45 and 64 years
|
58 Participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
39 Participants
n=5 Participants
|
|
Age, Customized
Unspecified
|
1 Participants
n=5 Participants
|
|
Age Continuous
|
61.6 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Resolution criteria: clinical cure, defined as negative results of a compressive ultrasound examination of the leg
Outcome measures
| Measure |
Dalteparin
n=102 Participants
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.
|
|---|---|
|
Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg
|
43 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Dalteparin
n=102 Participants
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.
|
|---|---|
|
Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline through Month 6 or EOT (up to Month 6)Population: Safety analysis set.
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.
Outcome measures
| Measure |
Dalteparin
n=102 Participants
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.
|
|---|---|
|
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 outcome
Timeframe: 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.
PE (diagnosed on the basis of ventilation-perfusion scan of the lungs or autopsy)
Outcome measures
| Measure |
Dalteparin
n=102 Participants
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.
|
|---|---|
|
Percent of Participants With and Without Pulmonary Embolism (PE)
Baseline without PE (n = 82)
|
80.4 Percent of participants
|
|
Percent of Participants With and Without Pulmonary Embolism (PE)
Week 2 without PE (n = 85)
|
83.3 Percent of participants
|
|
Percent of Participants With and Without Pulmonary Embolism (PE)
Month 1 with PE (n = 3)
|
2.9 Percent of participants
|
|
Percent of Participants With and Without Pulmonary Embolism (PE)
Month 3 with PE (n = 1)
|
1.0 Percent of participants
|
|
Percent of Participants With and Without Pulmonary Embolism (PE)
Month 3 with missing information (n = 10)
|
9.8 Percent of participants
|
|
Percent of Participants With and Without Pulmonary Embolism (PE)
Month 6 or EOT without PE (n = 85)
|
83.3 Percent of participants
|
|
Percent of Participants With and Without Pulmonary Embolism (PE)
Baseline with PE (n = 16)
|
15.7 Percent of participants
|
|
Percent of Participants With and Without Pulmonary Embolism (PE)
Baseline with missing information (n = 4)
|
3.9 Percent of participants
|
|
Percent of Participants With and Without Pulmonary Embolism (PE)
Week 2 with PE (n = 7)
|
6.9 Percent of participants
|
|
Percent of Participants With and Without Pulmonary Embolism (PE)
Week 2 with missing information (n = 10)
|
9.8 Percent of participants
|
|
Percent of Participants With and Without Pulmonary Embolism (PE)
Month 1 without PE (n = 96)
|
94.1 Percent of participants
|
|
Percent of Participants With and Without Pulmonary Embolism (PE)
Month 1 with missing information (n = 3)
|
2.9 Percent of participants
|
|
Percent of Participants With and Without Pulmonary Embolism (PE)
Month 3 without PE (n = 91)
|
89.2 Percent of participants
|
|
Percent of Participants With and Without Pulmonary Embolism (PE)
Month 6 or EOT with PE (n = 3)
|
2.9 Percent of participants
|
|
Percent of Participants With and Without Pulmonary Embolism (PE)
Month 6 or EOT with missing information (n = 14)
|
13.7 Percent of participants
|
SECONDARY outcome
Timeframe: Month 6 or EOT (up to Month 6)Population: FAS
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
Outcome measures
| Measure |
Dalteparin
n=102 Participants
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.
|
|---|---|
|
Number of Participants With Recurrent DVT
|
3 Participants
|
Adverse Events
Dalteparin
Serious adverse events
| Measure |
Dalteparin
n=102 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Cardiopulmonary failure
|
2.0%
2/102
|
|
General disorders
Disease progression
|
8.8%
9/102
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.98%
1/102
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.98%
1/102
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.98%
1/102
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.98%
1/102
|
|
Vascular disorders
Embolism
|
0.98%
1/102
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER