Abstract
Background: Bevacizumab (BEV) is pivotal for anti-angiogenic therapy in recurrent ovarian cancer (ROC), but its real-world bleeding risk profile and standardized management remain to be refined, demanding tailored pharmacovigilance data for clinical decision-making. Objectives: This single-center retrospective study characterized BEV-related bleeding events, explored the association between vascular protection management and coagulation-fibrinolysis/inflammation markers and provided bleeding risk prevention guidance. Methods: This single-center retrospective study was conducted in Nanjing, China, from October 2024 to September 2025, with follow-up completed by December 2025. Data were extracted from electronic medical records, laboratory information systems, pharmacy records, infusion records, and nursing documentation. Bleeding was graded per CTCAE v5.0; vascular protection metrics and dynamic changes of biochemical markers (Hb, PLT, FIB, D-dimer, and CRP) were collected and analyzed. Results: 22.5% had any-grade bleeding and 15.8% grade ?2 bleeding, mostly mucocutaneous and clustered in early treatment. Compared to the non-bleeding group, the bleeding group exhibited higher concomitant drug use, a higher prevalence of hypertension, and lower vascular protection compliance (all P < 0.05). Additionally, this group experienced significant declines in Hb, PLT, and FIB, alongside elevated D-dimer and CRP levels (all P < 0.05). Conclusion: BEV-related bleeding has distinct features, associated with concomitant drugs, inadequate vascular protection and abnormal coagulation/inflammation markers. Integrating pharmacovigilance and multispecialty vascular protection strategies can effectively mitigate bleeding risk and reduce treatment disruptions.