The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism \[VTE\] in cancer patients at high risk for VTE and who were undergoing chemotherapy. The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.
Randomization had to take place just prior to the first study drug injection (randomization ratio 1:1). The study period per participant was variable depending on the duration of chemotherapy. It included: * a screening period up to 3 weeks, * a double-blind treatment period, * a follow-up period of 1 month. Study end date was at the latest 7 months following the randomization of the last participant (6 months treatment and 1 month follow-up).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
3,212
0.4 mL solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection
0.4 mL solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance but without active component Subcutaneous injection
Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death
VTE included any symptomatic Deep Vein Thrombosis \[DVT\] of lower or upper limbs and any non-fatal Pulmonary Embolism \[PE\] as confirmed by a Central Independent Adjudication Committee \[CIAC\] after review of compression ultrasound or venography for DVT, ventilation/perfusion lung scan, pulmonary angiogram or spiral computer tomography lung scan for PE. VTE-related death included fatal PE and unexplained deaths without confirmatory autopsy. Any sudden death could be classified as fatal PE by the CIAC unless diagnostic test results strongly indicated an alternative diagnosis".
Time frame: From randomization up to 3 days after last study drug injection
Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function)
Participants alive and not having experienced VTE were right censored at last study drug injection plus 3 days. In order to correct for competing risks (Deaths other than VTE-related death), a model of cause-specific hazards was used to estimate the Cumulative incidence Function with Prentice non-parametric estimator.
Time frame: From randomization up to 3 days after last study drug injection
Percentage of Participants who required the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment
Initiation of curative anticoagulant or thrombolytic treatment after VTE assessment was defined from investigator's answer to the question "was the subject treated for VTE?" asked after diagnostic tests for suspected VTE and after lung imaging test for tumor evaluation.
Time frame: From randomization up to 3 days after last study drug injection
Percentage of Participants Who Experienced Clinically Relevant Bleedings
Clinically Relevant Bleedings included overt bleedings classified by the CIAC as: * "major" (fatal, in a critical area/organ, causing a drop in hemoglobin ≥2 g/dL or requiring transfusion ≥2 units of blood) * "clinically relevant non-major" (requiring medical intervention and not meeting criteria for major bleeding).
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Investigational Site Number 840006
Birmingham, Alabama, United States
Investigational Site Number 840007
Casa Grande, Arizona, United States
Investigational Site Number 840060
Tucson, Arizona, United States
Investigational Site Number 840050
Fountain Valley, California, United States
Investigational Site Number 840072
Fullerton, California, United States
Investigational Site Number 840037
Indian Wells, California, United States
Investigational Site Number 840069
La Verne, California, United States
Investigational Site Number 840009
Long Beach, California, United States
Investigational Site Number 840001
Oceanside, California, United States
Investigational Site Number 840011
Rancho Mirage, California, United States
...and 401 more locations
Time frame: From first study drug injection up to 3 days after last study drug injection
Overall survival [OS]
Survival status was collected for all participants either one year after randomization, or at the study end date, (ie, 7 months following randomization of the last patient), whichever came first. OS was defined as the time from date of randomization to date of death due to any cause. Participants alive were censored at last date of contact that they were known to be alive.
Time frame: From randomization up to 1 year after randomization or 7 months following randomization of the last participant, whichever came first