PMID- 31696432
OWN - NLM
STAT- MEDLINE
DCOM- 20200512
LR  - 20210110
IS  - 1179-1942 (Electronic)
IS  - 0114-5916 (Linking)
VI  - 42
IP  - 12
DP  - 2019 Dec
TI  - Rheumatology Common Toxicity Criteria (RCTC): An Update Reflecting Real-World 
      Use.
PG  - 1499-1506
LID - 10.1007/s40264-019-00864-9 [doi]
AB  - INTRODUCTION: The Outcome Measures in Rheumatology Clinical Trials (OMERACT) 
      Rheumatology Common Toxicity Criteria (RCTC) version 2.0 was published in 2007 by 
      the OMERACT Drug Safety Working Group, building on limited experience with RCTC 
      version 1.0, to facilitate standardization of assessment (grading) and reporting 
      of adverse events (AEs) commonly seen in rheumatic disease clinical trials 
      (Woodworth et al. in J Rheumatol 34:1401-1414, 2007). OBJECTIVES: The objectives 
      of this study were to (1) report the real-world performance of RCTC 2.0; (2) 
      report immediately correctable errors in RCTC 2.0, and provide a revised RCTC 
      2.1; and (3) begin to identify the need for a comprehensive revision of RCTC 2.0. 
      METHODS: Safety data outputs for several large rheumatic/autoimmune disease 
      clinical trials in which RCTC 2.0 was used were evaluated for accuracy of 
      reporting and the ability to assess differences among treatments. We examined 
      RCTC 2.0 tables for errors, as well as for omission of terms for AEs that 
      commonly occur in more recent rheumatology clinical trials. We also considered 
      recommendations from recent US Food and Drug Administration (FDA) and 
      international initiatives such CDISC (Clinical Data Interchange Standards 
      Consortium) to improve the consistency of safety data collection and 
      interpretability of safety data analyses. RESULTS: RCTC 2.0 enabled comparisons 
      of safety data across treatment groups, including grading. However, we discovered 
      inaccuracies in laboratory results grading and omission of AE terms now 
      recognized to occur in rheumatic disease clinical trials. CONCLUSION: The RCTC 
      2.0 performed as intended, although some inaccuracies and omissions were found. 
      We provide a corrected version, RCTC 2.1, and also recommend further revision of 
      the RCTC within OMERACT guidances to include AEs that have been reported in 
      rheumatology clinical trials since RCTC 2.0 was published. Ideally, a revised 
      RCTC 3.0 would not only facilitate standardized assessment and reporting of AEs, 
      but would also expand and encourage accurate comparison of the safety profiles of 
      treatments for rheumatic/autoimmune diseases.
FAU - Stach, Christian M
AU  - Stach CM
AUID- ORCID: 0000-0001-9206-1887
AD  - UCB Biosciences GmbH, Monheim, Germany.
FAU - Sloan, Victor S
AU  - Sloan VS
AUID- ORCID: 0000-0001-5906-4584
AD  - UCB Biosciences Inc, Research Triangle Park, NC, USA.
AD  - Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ, USA.
FAU - Woodworth, Thasia G
AU  - Woodworth TG
AUID- ORCID: 0000-0002-6760-7451
AD  - Division of Rheumatology, David Geffen School of Medicine, University of 
      California, Los Angeles, 1000 Veterans Ave, Los Angeles, CA, 90095, USA. 
      tgwoodworth@me.com.
FAU - Kilgallen, Brian
AU  - Kilgallen B
AD  - SDC, Tempe, AZ, USA.
FAU - Furst, Daniel E
AU  - Furst DE
AD  - Division of Rheumatology, David Geffen School of Medicine, University of 
      California, Los Angeles, 1000 Veterans Ave, Los Angeles, CA, 90095, USA.
AD  - University of Washington, Seattle, WA, USA.
AD  - University of Florence, Florence, Italy.
LA  - eng
PT  - Journal Article
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
RN  - 0 (Antirheumatic Agents)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - Antirheumatic Agents/*adverse effects
MH  - Autoimmune Diseases/complications/drug therapy
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Humans
MH  - Patient Safety
MH  - Randomized Controlled Trials as Topic
MH  - Rheumatic Diseases/complications/drug therapy
MH  - Rheumatology/*trends
MH  - Treatment Outcome
EDAT- 2019/11/07 06:00
MHDA- 2020/05/13 06:00
CRDT- 2019/11/08 06:00
PHST- 2019/11/07 06:00 [pubmed]
PHST- 2020/05/13 06:00 [medline]
PHST- 2019/11/08 06:00 [entrez]
AID - 10.1007/s40264-019-00864-9 [pii]
AID - 10.1007/s40264-019-00864-9 [doi]
PST - ppublish
SO  - Drug Saf. 2019 Dec;42(12):1499-1506. doi: 10.1007/s40264-019-00864-9.