Transcription of Implementing Laboratory Toxicity Grading for CTCAE Version 5
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Implementing Laboratory Toxicity Grading for CTCAE Version 5
PharmaSUG 2019 - Paper BP-128. Implementing Laboratory Toxicity Grading for CTCAE Version 5. Keith Shusterman, Reata Pharmaceutics, Inc.;. Mario Widel, Independent Contractor ABSTRACT. Laboratory Toxicity Grading has been an important part of safety reporting since the FDA began accepting electronic data in 1999. Staying up to date with the various CTCAE versions can be a challenge. CTCAE . Version adds a layer of complexity with new Grading criteria dependent on baseline measurements. We will present a practical method for deriving Toxicity grades in the SDTM LB domain based on the new CTCAE , as well as reporting Toxicity events in an OCCDS dataset derived separately from the BDS.
In CTCAE version 4.03, toxicity grades for this adverse event are calculated explicitly in ranges related to the upper limit of normal (ULN) as shown below in Table 1. Grade 1 Grade 2 Grade 3 Grade 4 >ULN - 2.5 x ULN >2.5 - 5.0 x ULN >5.0 - 20.0 x ULN >20.0 x ULN Table 1: “Alkaline Phosphatase Increased” grading criteria from CTCAE version ...
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