Signal management and risk minimization strategy: a case study on obinutuzumab and non-overt disseminated intravascular coagulation

• Main Authors: Giulia Valdiserra (Author), Nadia Mores (Author), Rosalba Elisabetta Rocchi (Author), Laura Sottosanti (Author), Patrizia Felicetti (Author), Pasquale Marchione (Author), Luca Laurenti (Author), Alberto Fresa (Author), Giampaolo Bucaneve (Author), Emiliano Cappello (Author), Marco Bonaso (Author), Sara Ferraro (Author), Irma Convertino (Author), Marco Tuccori (Author)
• Format: Book
• Published: Frontiers Media S.A., 2023-07-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Introduction: In December 2020, the Italian Medicines Agency (AIFA) in collaboration with the Italian Regional Centers of Pharmacovigilance evaluated four individual case safety reports (ICSRs) reporting obinutuzumab and non-overt disseminated intravascular coagulation (DIC) as a new possible signal...