Variable Name,,Variable Label,Type,Codelist/ Controlled Terms,Core,CDISC Notes
PARAM,,Parameter,Char,,Req,"The description of the analysis parameter. PARAM must include all descriptive and qualifying information relevant to the analysis purpose of the parameter.
Some examples are: ""Supine Systolic Blood Pressure (mm Hg)"", ""Log10 (Weight (kg))"", ""Time to First Hypertension Event (Days)"", and ""Estimated Tumor Growth Rate"". PARAM should be sufficient to describe unambiguously the contents of AVAL and/or AVALC.
Examples of qualifying information that might be relevant to analysis, and are therefore 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 is restricted to a maximum of 200 characters. If the value of PARAM will be used as a variable label in a transposed dataset,
then the producer may wish to limit the value of PARAM to 40 characters. Such limitation to 40 characters should not compromise the integrity of the description.
PARAM is often directly usable in Clinical Study Report displays. Note that in the ADaMIG, ""parameter"" is a synonym of ""analysis parameter.""
PARAM must be present and populated on every record in a BDS dataset."
PARAMCD,,Parameter Code,Char,,Req,"The short name of the analysis parameter in PARAM. The values of PARAMCD must be no more than 8 characters in length, start with a letter (not underscore), and be comprised only of letters (A-Z), underscore (_), and numerals (0-9). These constraints will allow for a BDS dataset to be transposed in such a way that the values of PARAMCD can be used as valid ADaM variable names per Section 3.1.1, General Variable Conventions. There must be a one-to-one relationship between PARAM and PARAMCD within a dataset.
PARAMCD must be present and populated on every record in a BDS dataset."
PARAMN,,Parameter (N),Num,,Perm,"Numeric representation of PARAM. Useful for ordering and programmatic manipulation. There must be a one-to-one relationship between PARAM and PARAMN within a dataset for all parameters where PARAMN is populated.
if PARAMN is populated on any record for a PARAM, it must be populated on every record for that PARAM."
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,"Numeric representation of PARCATy. Useful for the ordering of values of PARCATy or for other purposes. There must be a one-to- one relationship between PARCATy and PARCATyN within a dataset.
PARCATyN cannot be present unless PARCATy is also present. When PARCATy and PARCATyN are present, then on a given record, either both must be populated or both must be null."
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 relationship 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 relationship 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 relationship 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). AVALCATy is parameter variant."
AVALCAyN,,Analysis Value Category y (N),Num,,Perm,"Numeric representation of AVALCATy. Useful for ordering of values of AVALCATy or for other purposes. There must be a one- to-one relationship between AVALCAyN and AVALCATy within a parameter.
AVALCAyN cannot be present unless AVALCATy is also present. When AVALCATy and AVALCAyN are present, then on a given record, either both must be populated or both must be null."
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 relationship 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 relationship 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,"Numeric representation of BASECATy. Useful for ordering of values of BASECATy or for other purposes. There must be a one-to- one relationship between BASECAyN and BASECATy within a parameter. BASECAyN cannot be present unless BASECATy is also present. When BASECATy and BASECAyN are present, then on a given record, either both must be populated or both must be null."
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 for that PARAM within that dataset. Refer to Section 4.2.1.6, 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,"Numeric representation of CHGCATy. Useful for ordering of values of CHGCATy or for other purposes. There must be a one-to-one relationship between CHGCATyN and CHGCATy within a parameter.
CHGCATyN cannot be present unless CHGCATy is also present. When CHGCATy and CHGCATyN are present, then on a given record, either both must be populated or both must be null."
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,"Numeric representation of PCHGCATy. Useful for ordering of values of PCHGCATy or for other purposes. There must be a one- to-one relationship between PCHGCAyN and PCHGCATy within a parameter.
PCHGCAyN cannot be present unless PCHGCATy is also present. When PCHGCATy and PCHGCAyN are present, then on a given record, either both must be populated or both must be null."
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 within a parameter. SHIFTy can only be based on the change in value of any of the following pairs (BASECATy, AVALCATy), (BNRIND, ANRIND), (ByIND, AyIND), (BTOXGR, ATOXGR), (BTOXGRL, ATOXGRL), (BTOXGRH, ATOXGRH), (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 representation of SHIFTy. There must be a one-to-one relationship between SHIFTyN and SHIFTy within a parameter.SHIFTyN cannot be present unless SHIFTy is also present. When SHIFTy and SHIFTyN are present, then on a given record, either both must be populated or both must be null.If SHIFTyN is used for a given PARAM, SHIFTy and SHIFTyN should be populated (when calculable) for all post-baseline records of that PARAM regardless of whether that record is used for analysis."
BCHG,,Change to Baseline,Num,,Perm,"Change to baseline analysis value. Equal to BASE-AVAL. 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 BCHG is left to producer choice."
BCHGCATy,,Change to Baseline Category y,Char,,Perm,"A categorization of BCHG within a parameter. Not necessarily a one-to-one mapping to BCHG. The definition of BCHGCATy may vary by PARAM. For example, BCHGCAT1 may be used to categorize BCHG with respect to ranges of change in SYSBP; ""-10 to -5 mm Hg"", ""-5 to 0 mm Hg"" categories."
BCHGCAyN,,Change to Baseline Category y (N),Num,,Perm,"Numeric representation of BCHGCATy. Useful for ordering of values of BCHGCATy or for other purposes. There must be a one- to-one relationship between BCHGCAyN and BCHGCATy within a parameter.
BCHGCAyN cannot be present unless BCHGCATy is also present. When BCHGCATy and BCHGCAyN are present, then on a given record, either both must be populated or both must be null."
PBCHG,,Percent Change to Baseline,Num,,Perm,"Percent change to baseline analysis value. Equal to ((BASE- AVAL)/AVAL)*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 PBCHG is left to producer choice"
PBCHGCAy,,Percent Change to Baseline Category y,Char,,Perm,"A categorization of PBCHG within a parameter. Not necessarily a one-to-one mapping to PBCHG. The definition of PBCHGCAy may vary by PARAM. For example, PBCHGCA1 may be used to categorize PBCHG with respect to ranges of change in SYSBP; "">5%"", "">10%"" categories."
PBCHGCyN,,Percent Change to Baseline Category y (N),Num,,Perm,"Numeric representation of PBCHGCAy. Useful for ordering of values of PBCHGCAy or for other purposes. There must be a one- to-one relationship between PBCHGCyN and PBCHGCAy within a parameter.
PBCHGCyN cannot be present unless PBCHGCAy is also present. When PBCHGCAy and PBCHGCyN are present, then on a given record, either both must be populated or both must be null."
