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CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 Hemolytic uremic syndrome - - Laboratory findings with clinical consequences (e g , renal insufficiency, petechiae) Life-threatening consequences, (e g , CNS hemorrhage or thrombosis/embolism or renal failure) Death Definition:
Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE A Semi-colon indicates ‘or’ within the description of the grade An ‘Em dash’ (—) indicates a grade not available Not all Grades are appropriate for all AEs Therefore, some AEs are listed with fewer than five options for Grade
For others, maybe only grade 2–5 events will be recorded The protocol should clearly outline what types of AEs will be recorded • Although CRFs vary, some common elements will always be recorded: • Date the AE began • Treatment for the AE • Description and severity/grade of the AE • Attribution of the AE • Date the AE resolved
Values below Grade 1 Any laboratory value that is between the ULN and grade 1 (for high values) or the LLN and grade 1 (for low values) should not be graded or reported as an AE Sites should consult the Manual for Expedited Reporting of Adverse Events to DAIDS, Version 2 0 and their protocol when making an assessment of the need to report an AE
• A good progress note(s) document ing an AE will contain both good clinical practice documentation and good clinical research practice documentation including: • Date the AE began (Note: It also may be important to time the AE, especially with infusion reactions ) • Treatment for the AE (e g , no treatment needed, further testing to