ࡱ> #` zbjbjmm 8z%%%%%8&&&&&'''U8W8W8W8W8W8W8$9h<<{8'''''{8&&8***'&&U8*'U8**:;/,/&& %+) g/ 0808q/R =5)` =// =/''*'''''{8{8* '''8''''!%% Date: May 17, 2010 Topic: CTEP Guidance: CTCAE v4.0 Grading Scales with Numeric Component From: CTEP, NCI Investigation Drug Branch CTEP has become aware of uncertainty regarding the grading of lab values using CTCAE v4.0. Some of the confusion arises from the use of computer systems to grade numeric lab values. The rationale within CTCAE v4.0 was to apply more clinical significance to the descriptions of grade because of clinical management decisions that are made based on the assignment of grade. Consequently grading is not always based on pure numeric values. The following guideline provides instruction regarding computer usage as a component of grade assignment for CTCAE v4.0 AE terms with quantitative severity scales. While CTEP is not endorsing the use of computer systems for grading AEs we recognize that lab interfaces are being used. It is the responsibility of the investigators to ensure that all AEs are accurately reported and graded. CTEP reviewed each CTCAE v4.0 term for which the grading scale included a quantitative component. While some grading scales include only numeric values/ranges alone, some grading scales include numeric values/ranges also include clinical assessment and/or intervention text. The attached table represents CTEPs Guideline on grading CTCAE v4.0 AE terms: Investigator input required: Grade should not be assigned based on numeric values alone. Potential use of lab interface: Grade potentially could be assigned using an electronic lab interface if the system is capable of managing the variables of baseline, ULN, and LLN across patients and laboratories MedDRA v12.0 CodeCTCAE v4.0 SOCCTCAE v4.0 TermCTEP Guidance for Grading10002272Blood and lymphatic system disordersAnemiaInvestigator input required10016288Blood and lymphatic system disordersFebrile neutropeniaInvestigator input required10019491Blood and lymphatic system disordersHemolysisInvestigator input required10024378Blood and lymphatic system disordersLeukocytosisInvestigator input required10000636InvestigationsActivated partial thromboplastin time prolongedInvestigator input required10014383InvestigationsElectrocardiogram QT corrected interval prolongedInvestigator input required10022402InvestigationsINR increasedInvestigator input required10000486Metabolism and nutrition disordersAcidosisInvestigator input required10001680Metabolism and nutrition disordersAlkalosisInvestigator input required10020587Metabolism and nutrition disordersHypercalcemiaInvestigator input required10020639Metabolism and nutrition disordersHyperglycemiaInvestigator input required10020647Metabolism and nutrition disordersHyperkalemiaInvestigator input required10020670Metabolism and nutrition disordersHypermagnesemiaInvestigator input required10020680Metabolism and nutrition disordersHypernatremiaInvestigator input required10020870Metabolism and nutrition disordersHypertriglyceridemiaInvestigator input required10020907Metabolism and nutrition disordersHyperuricemiaInvestigator input required10020943Metabolism and nutrition disordersHypoalbuminemiaInvestigator input required10020949Metabolism and nutrition disordersHypocalcemiaInvestigator input required10021005Metabolism and nutrition disordersHypoglycemiaInvestigator input required10021018Metabolism and nutrition disordersHypokalemiaInvestigator input required10021028Metabolism and nutrition disordersHypomagnesemiaInvestigator input required10021038Metabolism and nutrition disordersHyponatremiaInvestigator input required10021059Metabolism and nutrition disordersHypophosphatemiaInvestigator input required10069339Renal and urinary disordersAcute kidney injuryInvestigator input required10064848Renal and urinary disordersChronic kidney diseaseInvestigator input required10019489Renal and urinary disordersHemoglobinuriaInvestigator input required10001551InvestigationsAlanine aminotransferase increasedPotential use of lab interface10001675InvestigationsAlkaline phosphatase increasedPotential use of lab interface10003481InvestigationsAspartate aminotransferase increasedPotential use of lab interface10005364InvestigationsBlood bilirubin increasedPotential use of lab interface10007612InvestigationsCardiac troponin I increasedPotential use of lab interface10007613InvestigationsCardiac troponin T increasedPotential use of lab interface10007839InvestigationsCD4 lymphocytes decreasedPotential use of lab interface10008661InvestigationsCholesterol highPotential use of lab interface10011268InvestigationsCPK increasedPotential use of lab interface10011368InvestigationsCreatinine increasedPotential use of lab interface10016596InvestigationsFibrinogen decreasedPotential use of lab interface10056910InvestigationsGGT increasedPotential use of lab interface10019150InvestigationsHaptoglobin decreasedPotential use of lab interface10055599InvestigationsHemoglobin increasedPotential use of lab interface10024574InvestigationsLipase increasedPotential use of lab interface10025256InvestigationsLymphocyte count decreasedPotential use of lab interface10025258InvestigationsLymphocyte count increasedPotential use of lab interface10029366InvestigationsNeutrophil count decreasedPotential use of lab interface10035528InvestigationsPlatelet count decreasedPotential use of lab interface10040139InvestigationsSerum amylase increasedPotential use of lab interface10049182InvestigationsWhite blood cell decreasedPotential use of lab interface10037032Renal and urinary disordersProteinuriaPotential use of lab interface  YZ w l * + G O \ d IXa]^  opkllmrs'(,-(hfNh|HCJOJQJ^JaJnH tH .hfNh|H5CJOJQJ\^JaJnH tH  hfNh|Hhth h|H hh|HhSeGZ + YZ[\]^_`as $$Ifa$gdfNgdfN & Fgd & FgdfN 0^`0gdgdzwnnn $IfgdfN $$Ifa$gdfN|kd$$Ifl\='  h  8   tL'644 la]ytfN-A]wnnn $IfgdfN $$Ifa$gdfN|kd$$Ifl\=' h 8   tL'644 la]ytfN]^gwnnn $IfgdfN $$Ifa$gdfN|kd$$Ifl\=' h 8   tL'644 la]ytfN wnnn $IfgdfN $$Ifa$gdfN|kd$$Ifl\=' h 8   tL'644 la]ytfN  #Sownnn $IfgdfN $$Ifa$gdfN|kd$$Ifl\=' h 8   tL'644 la]ytfNopywnnn $IfgdfN $$Ifa$gdfN|kd$$Ifl\=' h 8   tL'644 la]ytfNwnnn $IfgdfN $$Ifa$gdfN|kd$$Ifl\=' h 8   tL'644 la]ytfN#FOkwnnn $IfgdfN $$Ifa$gdfN|kd$$Ifl\=' h 8   tL'644 la]ytfNkluwnnn $IfgdfN $$Ifa$gdfN|kdx$$Ifl\=' h 8   tL'644 la]ytfNwnnn $IfgdfN $$Ifa$gdfN|kdg$$Ifl\=' h 8   tL'644 la]ytfNBPlwnnn $IfgdfN $$Ifa$gdfN|kdV $$Ifl\=' h 8   tL'644 la]ytfNlmvwnnn $IfgdfN $$Ifa$gdfN|kdE 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