3.3.4.1.1 BDS Analysis Parameter Variables (Copy)

PARAM

Parameter

Char

Req

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

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

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.

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

SHIFTyN

Shift y (N)

Num

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.

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.

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.