Takuto Takahashi, Benjamin Watkins, Brandi Bratrude, Donna Neuberg, Kyle Hebert, Kayla Betz, Alison Yu, Sung W Choi, Jeffrey Davis, Christine Duncan, Roger Giller, Michael Grimley, Andrew C Harris, David Jacobsohn, Nahal Lalefar, Nosha Farhadfar, Michael A Pulsipher, Shalini Shenoy, Aleksandra Petrovic, Kirk R Schultz, Gregory A Yanik, Bruce R Blazar, John T Horan, Amelia Langston, Leslie S Kean, Muna Qayed
BACKGROUND: Although unrelated-donor (URD) hematopoietic cell transplantation (HCT) is associated with many toxicities, a detailed analysis of adverse events, as defined by the Common Terminology Criteria for Adverse Events (CTCAE), has not previously been curated. This represents a major unmet need, especially as it relates to assessing the safety of novel agents. METHODS: We analyzed a detailed AE database from the 'ABA2' randomized, double-blind, placebo-controlled clinical trial of abatacept for acute graft-versus-host disease (AGVHD) prevention, for which the FDA mandated a detailed AE assessment through Day+180, and weekly neutrophil and platelet counts through Day+100...
April 5, 2024: Transplantation and cellular therapy