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).
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
Buenos Aires, Argentina
Capital Federal, Argentina
Rosario, Argentina
San Miguel de Tucumán, Argentina
San Miguel de Tucumán, Argentina