Signal-rich and signal-poor: Divergent detection of early bacterial sepsis and latent viral complications after hematopoietic stem cell transplantation in the FDA adverse event reporting system (ASH 2025) - Nov 4, 2025 - Abstract #abs25-15587; 2509; Pres time: Dec 6, 2025; 05:30 PM - 07:30 PM; Location: OCCC - West Halls B3-B4; "Allo-HSCT cases were identified using MedDRA indication terms, witha drug-based heuristic classifying records listing a graft-versus-host disease (GVHD) prophylactic agent (e.g., tacrolimus,cyclosporine, sirolimus, or post-transplant cyclophosphamide) as allogeneic...Contemporary meta-analyses report 10–20% clinically significant CMV incidence despite letermovir prophylaxis, underscoring under-ascertainment in FAERS...Regulators and investigators shouldprioritize FAERS for severe, early toxicities, while relying on transplant registries and EHR linkages to track prophylaxis-modulated or slow-onset infections. Future integration of FAERS with registry denominators may help calibratepharmacovigilance sensitivity across the post-HSCT infection spectrum."
Adverse events • Bone Marrow Transplantation • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Graft versus Host Disease • Immunology • Infectious Disease • Septic Shock • Transplantation • ROR1
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Manzer Ali1; Bolivia Fernandes2; Rajesh Thirumaran3; Hanzala Jehangir4; Kirti Arora5; Kevin Bera6; Daniel Rosas7; Muhammad Awais Bin Abdul Malik 8; Aftab Ahmed3; Mohammed AL-Jumayli9; Jamal Abdul Nasir10; Rameen Nadeem Nadeem11
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