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Rheumatology Common Toxicity Criteria (RCTC): An Update Reflecting Real-World Use.

Christian M Stach1, Victor S Sloan2,3, Thasia G Woodworth4

  • 1UCB Biosciences GmbH, Monheim, Germany.

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|November 8, 2019
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Summary
This summary is machine-generated.

The Rheumatology Common Toxicity Criteria (RCTC) 2.0 has inaccuracies and omissions in adverse event reporting for rheumatic diseases. A revised version, RCTC 2.1, is provided, with recommendations for future comprehensive revisions.

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Area of Science:

  • Rheumatology
  • Clinical Trials
  • Drug Safety

Background:

  • The Outcome Measures in Rheumatology Clinical Trials (OMERACT) Rheumatology Common Toxicity Criteria (RCTC) version 2.0 was developed to standardize adverse event (AE) assessment in rheumatic disease clinical trials.
  • Published in 2007, RCTC 2.0 built upon limited experience with its predecessor to improve reporting consistency.

Purpose of the Study:

  • Evaluate the real-world performance of RCTC 2.0.
  • Identify and correct errors in RCTC 2.0, leading to the development of RCTC 2.1.
  • Assess the need for a comprehensive revision of RCTC 2.0.

Main Methods:

  • Analysis of safety data from large rheumatic/autoimmune disease clinical trials using RCTC 2.0.
  • Evaluation of RCTC 2.0 tables for reporting accuracy and omission of AE terms.
  • Consideration of recommendations from regulatory bodies (FDA) and international standards (CDISC).

Main Results:

  • RCTC 2.0 facilitated safety data comparisons across treatment groups, including grading.
  • Inaccuracies were identified in laboratory results grading.
  • Omission of AE terms commonly occurring in recent rheumatology trials was noted.

Conclusions:

  • RCTC 2.0 performed as intended but contained inaccuracies and omissions.
  • A corrected version, RCTC 2.1, is presented.
  • Further revision (RCTC 3.0) is recommended to encompass newly reported AEs and enhance safety profile comparisons.