What is the basis for CTCAE definition of value ranges (grades) for laboratory values?
Generally, the laboratory test values used to discriminate between AE grades in CTC v2.0 and CTCAE v3.0 is arbitrary and not validated. The grading system in many cases has divided into four discrete grade lab values whose deviation from baseline is associated with adverse sequeala in a continuous, non-stepwise defined manner. For example, while the distinction between a bilirubin of 1.5 and 1.7 x ULN is probably not clinically relevant, the developers and users of the criteria have agreed upon a cut-off of 1.5 x ULN to separate Grade 1 from Grade 2 hyperbilirubinemia. There are some instances when outcome data have influenced the choice of cutoff points, but even in these cases the cutoff cannot be viewed as a stepwise discriminant between two different risks. Back to VIII.
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