Application of a hemophilia mortality framework to the Emicizumab Global Safety Database.

ABSTRACT:

Background

As the first non-factor replacement therapy for persons with congenital hemophilia A (PwcHA), emicizumab's safety profile is of particular interest to the community.

Objectives

We applied an algorithm for categorization of fatal events contemporaneous to emicizumab using reporter-assessed causality documented in the Roche Emicizumab Global Safety Database.

Patients/methods

All fatalities in PwcHA reported to the database (from clinical trials, pre-market access, and spontaneous post-marketing reports) were categorized into: associated with hemophilia A-hemorrhagic, thrombotic, human immunodeficiency virus (HIV)/hepatitis C virus (HCV), hepatic (non-HCV); associated with general population-trauma/suicide, non-HA-associated conditions; or, unspecified. Report

SUBMITTER: Peyvandi F 

PROVIDER: S-EPMC7756327 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature