Why were the criteria relating to hematopoietic transplantation and leukemia removed from CTCAE?
The BMT and leukemia criteria were deleted from CTCAE v3.0 for two reasons. The first was that there was a consensus that the grading schema used should be consistent and independent of disease or treatment type unless there are data to support such a difference. A Grade 3 platelet AE assessment should be independent of the cause of the AE, whether it is from chemotherapy, a BMT, leukemia or solid tumor infiltration of the bone marrow, for example. Secondly, reporting of the same AE (e.g., platelets) was inconsistent. For example, in any one trial, data were often submitted under general platelet AE, BMT platelet criteria AE, or leukemia platelet AE. The = 4) BSPSPopupOnMouseOver(event);” class=”popupspot”>CTCDT judged this problem to be caused in part by the way CTC v2.0 leukemia and BMT criteria were set up, so after a review of these criteria, it was decided that it was most logical and efficient to collapse the BMT and leukemia criteria into other existing AEs. The CTCAE Revision C
