6/29/23, 11:41 PM SAVE-ONCO Pathway Feedback Search Clinical Topics Home Studies SAVE ONCO SAVE ONCO Disease Cancer-associated thrombosis Trial question What is the role of semuloparin in patients receiving chemotherapy for cancer? Study design Multi-center Double blinded RCT Population Characteristics of study participants 40.0% female N = 3212 60.0% male 3212 patients (1282 female, 1930 male) Inclusion criteria: patients with metastatic or locally advanced solid tumors who were beginning to receive a course of chemotherapy Key exclusion criteria: life expectancy < 3 months; ECOG performance status 3; calculated CrCl < 30 mL/min; major surgery in < 4 weeks; contraindication to anticoagulation; requirement to thromboprophylaxis Interventions N=1608 semuloparin (subcutaneous dose of 20 mg once daily) N=1604 placebo (matching placebo once daily) Primary outcome https://web.pathway.md/studies/recpZojIJk86xWPqF 1/2 6/29/23, 11:41 PM SAVE-ONCO Pathway Composite outcome of symptomatic deep vein thrombosis, nonfatal pulmonary embolism, and death related to venous thromboembolism 3.4 % 3.4 2.5 % 1.7 % Significant decrease 1.2 0.8 % NNT = 45 0.0 % Semuloparin Placebo Significant decrease in composite outcome of symptomatic deep vein thrombosis, nonfatal PE, and death related to VTE (1.2% vs. 3.4%; HR 0.36, 95% CI 0.21 to 0.6) Secondary outcomes No significant difference in death (43.4% vs. 44.5%; HR 0.96, 96% CI 0.86 to 1.06) Borderline significant decrease in symptomatic deep vein thrombosis (0.7% vs. 2.1%; HR 0.32, 95% CI 0.15 to 0.62) Borderline significant decrease in PE (0.6% vs. 1.5%; HR 0.41, 95% CI 0.19 to 0.85) Safety outcomes No significant differences in major bleeding, clinically relevant nonmajor bleeding and serious adverse events. Conclusion In patients with metastatic or locally advanced solid tumors who were beginning to receive a course of chemotherapy, semuloparin was superior to placebo with respect to the composite outcome of symptomatic deep vein thrombosis, nonfatal PE, and death related to VTE. Reference Giancarlo Agnelli, Daniel J George, Ajay K Kakkar et al. Semuloparin for thromboprophylaxis in patients receiving chemotherapy for cancer. N Engl J Med. 2012 Feb 16;366(7):601-9. Open reference URL https://web.pathway.md/studies/recpZojIJk86xWPqF 2/2