Variable Name,Variable Label,Type,"Codelist/
Controlled Terms",Core,CDISC Notes
PARAM,Parameter,Char,,Req,"The description of the analysis parameter. Examples include: “Supine Systolic Blood Pressure (mm Hg)”, “Log10 (Weight (kg))”, “Time to First Hypertension Event (Days)”, “Estimated Tumor Growth Rate”, etc. PARAM should be sufficient to describe unambiguously the contents of AVAL and/or AVALC. PARAM must include all descriptive and qualifying information relevant to the analysis purpose of the parameter.
Examples of qualifying information that might be relevant to analysis and therefore are candidates for inclusion in PARAM are units, specimen type, location, position, machine type, and transformation function. There is no need to include qualifiers that are not relevant to the analysis of PARAM. In contrast to SDTM --TEST, no additional variable is needed to further qualify PARAM.
PARAM may be longer than 40 characters in length but is restricted to a maximum of 200 characters. PARAM is often directly usable in Clinical Study Report displays. Note that in the
ADaMIG, “parameter” is a synonym of “analysis parameter.”"
PARAMCD,Parameter Code,Char,,Req,"The short name of the analysis parameter in PARAM. Values of PARAMCD should follow the SAS Version 5 transport file format and Oracle constraints as noted under General Variable
Conventions in Section 3.1.1. There must be a one-to-one mapping to PARAM within a dataset."
PARAMN,Parameter (N),Num,,Perm,"A numeric representation of PARAM. Useful for ordering and programmatic manipulation. There
must be a one-to-one mapping to PARAM within a dataset."
PARAMTYP,Parameter Type,Char,(PARAMTYP),Perm,"Indicator of whether the parameter is derived as a function of one or more other parameters.
This variable will be retired from the ADaMIG in the next version because it was confused with the concept of DTYPE and therefore was being misused. The variable metadata should be adequate to indicate when a parameter is wholly derived."
PARCATy,Parameter Category y,Char,,Perm,"A categorization of PARAM within a dataset. For example, values of PARCAT1 might group the parameters having to do with a particular questionnaire, lab specimen type, or area of investigation. Note that PARCATy is not a qualifier for PARAM. PARAM to PARCATy is a many-to-one mapping; any given PARAM may be associated with at most one level of PARCATy (e.g., one
level of PARCAT1 and one level of PARCAT2)."
PARCATyN,"Parameter Category
y (N)",Num,,Perm,"A numeric representation of PARCATy. This can be used for operations on PARCATy. There must
be a one-to-one relationship within a dataset between PARCATy and PARCATyN."
AVAL,Analysis Value,Num,,Cond,"Numeric analysis value described by PARAM. On a given record, it is permissible for AVAL, AVALC, or both to be null. AVAL is required if AVALC is not present, since either AVAL or
AVALC must be present in the dataset."
AVALC,Analysis Value (C),Char,,Cond,"Character analysis value described by PARAM. AVALC can be a character string mapping to AVAL, but if so there must be a one-to-one map between AVAL and AVALC within a given PARAM. AVALC should not be used to categorize the values of AVAL. Within a given parameter, if there exists a row on which both AVALC and AVAL are populated, then there must be a one-to- one mapping between AVALC and AVAL on all rows on which both variables are populated. (In other words, there is no requirement that records with a null value in either AVAL or AVALC be included when determining whether the one-to-one mapping requirement is satisfied.) On a given record, it is permissible for AVAL, AVALC, or both to be null.
AVALC is required if AVAL is not present, since either AVAL or AVALC must be present in the dataset."
AVALCATy,Analysis Value Category y,Char,,Perm,"A categorization of AVAL or AVALC within a parameter. Not necessarily a one-to-one mapping to AVAL and/or AVALC. For example, if PARAM is “Headache Severity” and AVAL has values 0, 1, 2, or 3, AVALCAT1 can categorize AVAL into “None or Mild” (for AVAL 0 or 1) and
“Moderate or Severe” (for AVAL 2 or 3)."
AVALCAyN,Analysis Value Category y (N),Num,,Perm,"A numeric representation of AVALCATy. This can be used for ordering of values of AVALCATy
or for other purposes. There must be a one-to-one relationship within a parameter between AVALCATy and AVALCAyN."
BASE,Baseline Value,Num,,Cond,"The subject’s baseline analysis value for a parameter and baseline definition (i.e. BASETYPE) if present. BASE contains the value of AVAL copied from a record within the parameter on which ABLFL = “Y”. Required if dataset supports analysis or review of numeric baseline value or functions of numeric baseline value. If BASE is populated for a parameter, and BASE is non-null for a subject for that parameter, then there must be a record flagged by ABLFL for that subject and parameter. Note that a baseline record may be derived (e.g., it may be an average) in which case
DTYPE must be populated on the baseline record."
BASEC,Baseline Value (C),Char,,Perm,"The subject’s baseline value of AVALC for a parameter and baseline definition (i.e. BASETYPE) if present. May be needed when AVALC is of interest. BASEC contains the value of AVALC copied from a record within the parameter on which ABLFL = “Y”. If both AVAL and AVALC are populated within a parameter, the baseline record for AVALC must be the same record as that for AVAL.
Within a given parameter, if there exists a row on which both BASEC and BASE are populated, then there must be a one-to-one mapping between BASEC and BASE on all rows on which both variables are populated. (In other words, there is no requirement that records with a null value in either BASE or BASEC be included when determining whether the one-to-one mapping requirement is satisfied.) On a given record, it is permissible for BASE, BASEC, or both to be null."
BASECATy,Baseline Category y,Char,,Perm,"A categorization of BASE or BASEC within a parameter. Not necessarily a one-to-one mapping to BASE or BASEC. For example, if PARAM is “Headache Severity” and AVAL has values 0, 1, 2, or 3, BASECAT1 can categorize BASE into “None or Mild” (for BASE 0 or 1) and “Moderate or
Severe” (for BASE 2 or 3)."
BASECAyN,Baseline Category y (N),Num,,Perm,"A numeric representation of BASECATy. This can be used for ordering of values of BASECATy
or for other purposes. There must be a one-to-one relationship within a parameter between BASECATy and BASECAyN."
BASETYPE,Baseline Type,Char,,Cond,"Producer-defined text describing the definition of baseline relevant to the value of BASE on the current record. Required when there are multiple ways that baseline is defined. If used for any PARAM within a dataset, should be non-null for all records of that dataset. Refer to Section 4.2.1,
Rule 6, for an example."
CHG,Change from Baseline,Num,,Perm,"Change from baseline analysis value. Equal to AVAL-BASE. If used for a given PARAM, should be populated for all post-baseline records of that PARAM regardless of whether that record is used
for analysis. The decision on how to populate pre-baseline and baseline values of CHG is left to producer choice."
CHGCATy,Change from Baseline Category y,Char,,Perm,"A categorization of CHG within a parameter. Not necessarily a one-to-one mapping to CHG. The definition of CHGCATy may vary by PARAM. For example, CHGCAT1 may be used to categorize CHG with respect to ranges of change in SYSBP; “-10 to -5 mm Hg”, “-5 to 0 mm Hg” categories."
CHGCATyN,Change from Baseline Category y (N),Num,,Perm,A numeric representation of CHGCATy. This can be used for ordering of values of CHGCATy or for other purposes. There must be a one-to-one relationship within a parameter between CHGCATy and CHGCATyN.
PCHG,Percent Change from Baseline,Num,,Perm,"Percent change from baseline analysis value. Equal to ((AVAL-BASE)/BASE)*100. If used for a given PARAM, should be populated (when calculable) for all post-baseline records of that PARAM regardless of whether that record is used for analysis. The decision on how to populate pre-baseline and baseline values of PCHG is left to producer choice."
PCHGCATy,Percent Chg from Baseline Category y,Char,,Perm,"A categorization of PCHG within a parameter. Not necessarily a one-to-one mapping to PCHG. The definition of PCHGCATy may vary by PARAM. For example, PCHGCAT1 may be used to
categorize PCHG with respect to ranges of change in SYSBP; “>5%”, “>10%” categories."
PCHGCAyN,Percent Chg from Baseline Category y (N),Num,,Perm,A numeric representation of PCHGCATy. This can be used for ordering of values of PCHGCATy or for other purposes. There must be a one-to-one relationship within a parameter between PCHGCATy and PCHGCAyN.
R2BASE,Ratio to Baseline,Num,,Perm,"Ratio to the baseline value. Equal to AVAL / BASE. If used for a given PARAM, should be populated for all post-baseline records of that PARAM regardless of whether that record is used for
analysis. The decision on how to populate pre-baseline and baseline values of R2BASE is left to producer choice."
R2AyLO,Ratio to Analysis Range y Lower Limit,Num,,Perm,"Ratio to the lower limit of the analysis range y. Equal to AVAL / AyLO. AyLO must exist in the ADaM dataset. If used for a given PARAM, should be populated for all post-baseline records of that PARAM regardless of whether that record is used for analysis. The decision on how to populate pre-baseline and baseline values of R2AyLO is left to producer choice."
R2AyHI,Ratio to Analysis Range y Upper Limit,Num,,Perm,"Ratio to the upper limit of the analysis range y. Equal to AVAL / AyHI. AyHI must exist in the ADaM dataset. If used for a given PARAM, should be populated for all post-baseline records of
that PARAM regardless of whether that record is used for analysis. The decision on how to populate pre-baseline and baseline values of R2AyHI is left to producer choice."
SHIFTy,Shift y,Char,,Perm,"A shift in values depending on the defined pairing for group y. SHIFTy can be based on the change in value of any of the following pairs (BASECATy, AVALCATy), (BNRIND, ANRIND), (ByIND, AyIND), (BTOXGR, ATOXGR), (BASE, AVAL) or (BASEC, AVALC). Useful for shift
tables. For example, “NORMAL to HIGH”. If used for a given PARAM, should be populated (when calculable) for all post-baseline records of that PARAM regardless of whether that record is
used for analysis. The decision on how to populate baseline and pre-baseline values of SHIFTy is left to producer choice."
SHIFTyN,Shift y (N),Num,,Perm,"Numeric version of SHIFTy. SHIFTyN maps one-to-one to SHIFTy within a parameter. If used for a given PARAM, should be populated (when calculable) for all post-baseline records of that PARAM regardless of whether that record is used for analysis. The decision on how to populate
baseline and pre-baseline values of SHIFTyN is left to producer choice."
