4.2.1 New Standard Non-Compartmental Analysis Variables

PK NCA Exclusion Flag 

Char

Y

Perm

Flag for exclusion of a record into a PK NCA calculation (Y = exclusion, Null = inclusion)

NCAXFN

PK NCA Exclusion Flag (N)

Num

Perm

Numeric flag for exclusion of a record into a PK NCA calculation (1 = exclusion, Null = inclusion). NCAXFN can only be included if NCAXFL is also included.

Char

Perm

This variable is used to explain why the record is not included in the PK NCA.  

NCAwXRSN

Reason for PK NCA Exclusion of w (N)

Num

Perm

This variable is used to explain why the record is not included in the PK NCA.

PK Summary Exclusion Flag

Char

Perm

Flag for exclusion of a record from a PK summary (1 = exclusion, Null = inclusion)

PKSUMXFN

PK Summary Exclusion Flag (N)

Num

1

Perm

METABFL

Metabolite Flag

Char

Y

Cond

Flag to designate if observations within a subject are associated with a metabolite. Required if parent drug and metabolites are present in the dataset.

Subject Cohort 

Char

Perm

Relevant to trials where cohorts are defined. This could be another grouping not necessarily associated with ARM.

COHORTN

Subject Cohort (N)

Num

Perm

Numeric representation of the COHORT variable. There must be a one-to-one mapping between COHORT and COHORTN. When COHORT and COHORTN are present, then, on a given record, either both must be populated or both must be null.

ROUTE

Route

Char

(ROUTE)

Perm

Route of treatment delivery. This variable can be a copy of EX.EXROUTE or EC.ECROUTE.  May instead be derived from the EX.EXROUTE or EC.ECROUTE.

TRTRINT

Planned Treatment Interval

Num

Perm

TRTRINTU

Planned Treatment Interval Units

Char

(UNIT)

Perm

Units associated with TRTRINT

DOSPCTDF

Percent Diff. Nominal vs. Actual Dose

Num

Cond

DOSEFRQ

Dose Frequency

Char

(FREQ)

ACYCLEC

Analysis Cycle (C)

Char

Perm

FANLDT

First Date of Dose for Analyte

Num

Perm

FANLTM

First Time of Dose for Analyte

Num

Perm

Time of first exposure to treatment associated with PARAM and ANALYTE for a subject in a study where multiple doses have been given. If treatment is given over a duration multiple times, this variable will reflect the start time of the first dose.

FANLDTM

First Datetime of Dose for Analyte

Num

Perm

Date and time of first exposure to treatment associated with PARAM and ANALYTE for a subject in a study where multiple doses have been given. If treatment is given over a duration multiple times, this variable will reflect the start date and time of the first dose.

FANLEDT

First End Date of Dose for Analyte

Num

Perm

First End Time of Dose for Analyte

Num

Perm

End time of first exposure to treatment associated with PARAM and ANALYTE for a subject in a study where multiple doses have been given. If treatment is given over a duration multiple times, this variable will reflect the end time of the first dose.

FANLEDTM

First End Datetime of Dose for Analyte

Num

Perm

End date and time of first exposure to treatment associated with PARAM and ANALYTE for a subject in a study where multiple doses have been given. If treatment is given over a duration multiple times, this variable will reflect the end date and time of the first dose.

PCRFTDT

Reference Date of Dose for Analyte

Num

Req

Date of reference exposure to treatment associated with PARAM and ANALYTE. Based on PC.PCRFTDTC and related to the analyzed profile. If this is a treatment over time, then this is typically the start of the dosing duration. 

PCRFTTM

Reference Time of Dose for Analyte

Num

Req

Time of reference exposure to treatment associated with PARAM and ANALYTE. Based on PC.PCRFTDTC and related to the analyzed profile. If this is a treatment over time, then this is typically the start of the dosing duration.

PCRFTDTM

Reference Datetime of Dose for Analyte

Num

Req

Date and time of reference exposure to treatment associated with PARAM and ANALYTE. Based on PC.PCRFTDTC and related to the analyzed profile. If this is a treatment over time, then this is typically the start of the dosing duration.

PCRFEDT

Reference End Date of Dose for Analyte

Num

Cond

The end date of reference exposure to treatment associated with PARAM and ANALYTE. Must be related to the time recorded in PC.PCRFTDTC and to the analyzed profile. If dosing occurs over an interval, this should be populated. If populated, ADOSEDUR and DOSEDURU are required to be filled out.

PCRFETM

Reference End Time of Dose for Analyte

Num

Cond

The end time of the reference exposure to treatment associated with PARAM and ANALYTE. Must be related to the time recorded in PC.PCRFTDTC and to the analyzed profile. If dosing occurs over an interval, this should be populated. If populated, ADOSEDUR and DOSEDURU are required to be filled out.

PCRFEDTM

Ref. End Datetime of Dose for Analyte

Num

Cond

The end date and time of the reference exposure to treatment associated with PARAM and ANALYTE. Must be related to the time recorded in PC.PCRFTDTC and to the analyzed profile. If dosing occurs over an interval, this should be populated. If populated, ADOSEDUR and DOSEDURU are required to be filled out.

Nom. Rel. Time from Analyte First Dose

Num

Perm

This is the planned elapsed time (for sample point or start of sampling interval) from first exposure to treatment associated with PARAM and ANALYTE.  For studies with an extended duration infusion, use the define to document if this is from the start or end of the infusion.

AFRLT

Act. Rel. Time from Analyte First Dose

Num

Perm

This is the actual elapsed time (for sample point or start of sampling interval) from first exposure to treatment associated with PARAM and ANALYTE. Note that this is referring to the first dose available for a particular drug. It is useful in multiple-dosing situations. 

NEFRLT

Nom. Rel. End Time from First Dose

Num

Perm

This is the planned elapsed end time of sampling interval from first exposure to study treatment.

AEFRLT

Act. Rel. End Time from First Dose

Num

Perm

This is the actual elapsed end time of sampling interval from first exposure to study treatment.

FRLTU

Rel. Time from First Dose Unit

Char

(PKUNIT)

Perm

This is the unit for all elapsed times from first dose.

NRRLT

Nominal Rel. Time from Ref. Dose 

Num

Req

This is the planned elapsed time (for sample point or start of sampling interval) from reference exposure to study treatment. 

Actual Rel. Time from Ref. Dose

Num

Req

This is the actual elapsed time (for sample point or start of sampling interval) from reference exposure to study treatment. 

MRRLT

Modified Rel. Time from Ref. Dose

Num

Perm

This variable could be used to modify the ARRLT variable based on analysis needs (e.g., setting negative values to zero or having a mix of nominal and actual time based of TMPCTDF).

Nominal Rel. End Time from Ref. Dose 

Num

This is the planned elapsed end time of sampling interval from reference exposure to study treatment.

AERRLT

Actual Rel. End Time from Ref. Dose

Num

This is the actual elapsed end time of sampling interval from reference exposure to study treatment.

MERRLT

Modified Rel. End Time from Ref. Dose

Num

Perm

This variable could be used to modify the AERRLT variable based on analysis needs (e.g., setting negative values to zero or having a mix of nominal and actual time based on TMPCTDF).

RRLTU

Rel. Time from Ref. Dose Unit

Char

(PKUNIT)

Req

This is the unit for all elapsed times from reference dose.

TMPCTDF

Percent Diff. Nominal vs. Actual Time

Num

Perm

This is the percent difference between nominal and actual time. It is derived by using the standard percent difference formula: 100*( NRRLT - ARRLT)/( NRRLT).

ADOSEDUR

Actual Duration of Treatment Dose

Num

Cond

NDOSEDUR

Nominal duration of Treatment Dose

Num

Cond

Nominal treatment duration as specified in the protocol, as measured in units given in DOSEDURU. This record is generally considered to be associated with an infusion dose.

DOSEDURU

Duration of Treatment Dose Units

Char

(PKUNIT)

Perm

AVALU

Analysis Value Unit

Char

Req

Unit for AVAL.

PCSPEC

Specimen Material Type

Char

(SPECTYPE)

Perm

Defines the type of specimen used for a measurement (e.g., SERUM, PLASMA, URINE). This column must be a direct copy of PC.PCSPEC. 

PCSTRESC

Character Result/Finding in Std Format

Char

Cond

Character results/findings in a standard format. The purpose of this column is to capture which records are BLQ or LLOQ in the AVAL column. This column must be a direct copy of PC.PCSTRESC.

PCSTRESU

Standard Units

Char

(UNIT)

PCLLOQ

Lower Limit of Quantitation

Num

Cond

VOLUME

Volume Value

Num

Cond

VOLUMEU

Volume Value Unit

Char

(UNIT)

Cond

PC.PCSTRESU from a PC volume record. Conditionally required if VOLUME is present.

SPWEIGHT

Specimen Weight Value

Num

Cond

SPWEIGHU

Specimen Weight Value Unit

Char

(UNIT)

Cond

PC.PCSTRESU from a PC weight record. Conditionally required if SPWEIGHT is present.

PCGRPID

Group ID

Char

Perm

Used to tie together a block of related records in a single domain to support relationships within the domain and between domains. Must be a direct copy of PC.PCGRPID.

PCSEQ

Sequence Number

Num

Cond

PC.PCSEQ associated with AVAL.