CTCAE 4 Revisions 9/15/2009 This file lists minor revisions to the base 4.0 data files released 5/29/2009. Revised data files are initially labeled with "rev1" ... at the end of their filenames, and for rev1 only Excel revised files were produced; other formats are produced if there is demand and time to do so. The rev2 version led to a consolidated set of 4.01 release files. The Archive directory stores release files prior to the current release. Release 4.02 (rev. 3) - 9/15/2009 77 AE Grades had minor fixes, none affecting meaning. 4 terms had fixes to definition text Remaining changes were to case, space and punctuation. Release 4.01 (rev. 2) - 7/14/2009 1 AE term definition added, 2 fixed, extra spaces removed: Grade 2 Hypoglycemia Missing definition added. Grade 1 Chronic Kidney Disease Missing "LLN - " added after "<" in middle of definition. Grade 4 Ejection fraction decreased Initial blank space removed from start of definition. 46 AE Grades marked as inapplicable ("-") Initial blank space(s) removed from before the "-" indicator. Revision 1 - 6/22/2009 MedDRA codes corrected for 2 AE terms: 10019663 Hepatic failure 10050528 Ejection fraction decreased