Variable Name,Variable Label,Type,Codelist/ Controlled Terms,Core,CDISC Notes
ATOXGR,"Analysis Toxicity
Grade",Char,,Perm,"Toxicity grade of AVAL or AVALC for analysis; may be based on SDTM --TOXGR or an
imputed or assigned value."
BTOXGR,"Baseline Toxicity
Grade",Char,,Perm,ATOXGR of the baseline record identified by ABLFL.
ANRIND,"Analysis Reference
Range Indicator",Char,,Perm,"Indicates where AVAL or AVALC falls with respect to the normal reference range for analysis;
may be based on SDTM --NRIND or an imputed or assigned value."
BNRIND,Baseline Reference Range Indicator,Char,,Perm,ANRIND of the baseline record identified by ABLFL.
ANRLO,"Analysis Normal
Range Lower Limit",Num *,,Perm,"Normal range lower limit for analysis; may be based on SDTM --NRLO or an imputed or assigned
value."
ANRLOC,Analysis Normal Range Lower Limit (C),Char,,Perm,"Character analysis normal range lower limit. ANRLOC can be a character string mapping to ANRLO, but if so there must be a one-to-one map between ANRLO and ANRLOC within a given PARAM. ANRLOC should not be used to categorize the values of ANRLO. Within a given parameter, if there exists a row on which both ANRLOC and ANRLO are populated, then there must be a one-to-one mapping between ANRLOC and ANRLO on all rows on which both variables are populated. (In other words, there is no requirement that records with a null value in either ANRLO or ANRLOC be included when determining whether the one-to-one mapping
requirement is satisfied.) On a given record, it is permissible for ANRLO, ANRLOC, or both to be null."
ANRHI,"Analysis Normal
Range Upper Limit",Num *,,Perm,"Normal range upper limit for analysis; may be based on SDTM --NRHI or an imputed or assigned
value."
ANRHIC,Analysis Normal Range Upper Limit (C),Char,,Perm,"Character analysis normal range upper limit. ANRHIC can be a character string mapping to ANRHI, but if so there must be a one-to-one map between ANRHI and ANRHIC within a given PARAM. ANRHIC should not be used to categorize the values of ANRHI. Within a given parameter, if there exists a row on which both ANRHIC and ANRHI are populated, then there must be a one-to-one mapping between ANRHIC and ANRHI on all rows on which both variables are populated. (In other words, there is no requirement that records with a null value in either ANRHI
or ANRHIC be included when determining whether the one-to-one mapping requirement is satisfied.) On a given record, it is permissible for ANRHI, ANRHIC, or both to be null."
AyLO,Analysis Range y Lower Limit,Num *,,Cond,"AyLO and/or AyHI are used for analysis ranges other than the normal range. AyLO and/or AyHI are created to capture the different levels of cutoff values used to determine whether an analysis is within a clinically acceptable value range or outside that value range. AyLO and/or AyHI are
usually but not necessarily constants, parameter-specific constants, or subject-specific constants. AyLO must be included if R2AyLO is included in the dataset."
AyLOC,Analysis Range y Lower Limit (C),Char,,Perm,"Character analysis range y lower limit. AyLOC can be a character string mapping to AyLO, but if so there must be a one-to-one map between AyLO and AyLOC within a given PARAM. AyLOC should not be used to categorize the values of AyLO. Within a given parameter, if there exists a row on which both AyLOC and AyLO are populated, then there must be a one-to-one mapping between AyLOC and AyLO on all rows on which both variables are populated. (In other words, there is no requirement that records with a null value in either AyLO or AyLOC be included when determining whether the one-to-one mapping requirement is satisfied.) On a given record, it is
permissible for AyLO, AyLOC, or both to be null."
AyHI,Analysis Range y Upper Limit,Num *,,Cond,"See AyLO.
For example, if ECG QTc values are summarized based on values >450, values >480, and values
>500, there is a need for 3 “hi value” range variables against which to compare values: A1HI=450, A2HI=480, A3HI=500.
AyHI must be included if R2AyHI is included in the dataset."
AyHIC,Analysis Range y Upper Limit (C),Char,,Perm,"Character analysis range y upper limit. AyHIC can be a character string mapping to AyHI, but if so there must be a one-to-one map between AyHI and AyHIC within a given PARAM. AyHIC should not be used to categorize the values of AyHI. Within a given parameter, if there exists a row on which both AyHIC and AyHI are populated, then there must be a one-to-one mapping between AyHIC and AyHI on all rows on which both variables are populated. (In other words, there is no requirement that records with a null value in either AyHI or AyHIC be included when determining
whether the one-to-one mapping requirement is satisfied.) On a given record, it is permissible for AyHI, AyHIC, or both to be null."
AyIND,"Analysis Range y
Indicator",Char,,Perm,"Indicates relationship of AVAL to the analysis range variables AyLO and/or AyHI, or the
relationship of AVALC to the analysis range variables AyLOC and/or AyHIC."
ByIND,"Baseline Analysis
Range y Indicator",Char,,Perm,AyIND of the baseline record identified by ABLFL.
