RT Journal Article
SR Electronic
T1 Standardizing assessment of adverse effects in rheumatology clinical trials. Status of OMERACT Toxicity Working Group March 2000: towards a common understanding of comparative toxicity/safety profiles for antirheumatic therapies.
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 1163
OP 1169
VO 28
IS 5
A1 Woodworth, T G
A1 Furst, D E
A1 Strand, V
A1 Kempeni, J
A1 Fenner, H
A1 Lau, C S
A1 Miller, F
A1 Day, R
A1 Lipani, J
A1 Brooks, P
YR 2001
UL http://www.jrheum.org/content/28/5/1163.abstract
AB This paper describes the background and current status of an OMERACT facilitated effort to improve the consistency of adverse event reporting in rheumatology clinical trials. The overall goal is the development of an adverse event assessment tool that would provide a basis for use of common terminology and improve the consistency of reporting severity of side effects within rheumatology clinical trials and during postmarketing surveillance. The resulting Rheumatology Common Toxicity Criteria Index encompassed the following organ systems: allergic/immunologic, cardiac, ENT, gastrointestinal, musculoskeletal, neuropsychiatric, ophthalmologic, pulmonary and skin/integument. Before this tool is widely accepted, its validity, consistency, and feasibility need to be assessed in clinical trials.