Journal article
A tool for assessing adverse events in phase I/II oncology clinical trials
Abstract
6518
Background: RECIST and NCI's Common Terminology Criteria are accepted systems that have standardized the reporting of oncology clinical trial outcomes. A standard system for attributing causality to Serious Adverse Events (SAEs) is lacking which can impact drug development and patient safety. The objectives of this study were to: 1) understand the clinical reasoning behind causality assessment during phase I/II oncology …
Authors
Coombes M; Mukherjee S; Kowaleski B; Levine M; Cosby J; Arnold A
Journal
Journal of Clinical Oncology, Vol. 25, No. 18_suppl, pp. 6518–6518
Publisher
American Society of Clinical Oncology (ASCO)
Publication Date
June 20, 2007
DOI
10.1200/jco.2007.25.18_suppl.6518
ISSN
0732-183X