Variable Name,Variable Label,Type,"Codelist/ Controlled
Terms",Core,CDISC Notes
ADT,Analysis Date,Num,,Perm,The date associated with AVAL and/or AVALC in numeric format.
ATM,Analysis Time,Num,,Perm,The time associated with AVAL and/or AVALC in numeric format.
ADTM,Analysis Datetime,Num,,Perm,The datetime associated with AVAL and/or AVALC in numeric format.
ADY,"Analysis Relative
Day",Num,,Perm,"The relative day of AVAL and/or AVALC. The number of days from an anchor date (not
necessarily DM.RFSTDTC) to ADT. See Section 3.1.2."
ADTF,"Analysis Date
Imputation Flag",Char,(DATEFL),Cond,"The level of imputation of analysis date. If ADT (or the date part of ADTM) was imputed, ADTF
must be populated and is required. See Section 3.1.3."
ATMF,"Analysis Time
Imputation Flag",Char,(TIMEFL),Cond,"The level of imputation of analysis time. If ATM (or the time part of ADTM) was imputed, ATMF
must be populated and is required. See Section 3.1.3."
ASTDT,Analysis Start Date,Num,,Perm,"The start date associated with AVAL and/or AVALC. ASTDT and AENDT may be useful for traceability when AVAL summarizes data collected over an interval of time, or when AVAL is a
duration."
ASTTM,Analysis Start Time,Num,,Perm,"The start time associated with AVAL and/or AVALC. ASTTM and AENTM may be useful for traceability when AVAL summarizes data collected over an interval of time, or when AVAL is a
duration."
ASTDTM,Analysis Start Datetime,Num,,Perm,"The start datetime associated with AVAL and/or AVALC. ASTDTM and AENDTM may be useful
for traceability when AVAL summarizes data collected over an interval of time, or when AVAL is a duration."
ASTDY,"Analysis Start
Relative Day",Num,,Perm,"The number of days from an anchor date (not necessarily DM.RFSTDTC) to ASTDT. See Section
3.1.2."
ASTDTF,"Analysis Start Date
Imputation Flag",Char,(DATEFL),Cond,"The level of imputation of analysis start date. If ASTDT (or the date part of ASTDTM) was
imputed, ASTDTF must be populated and is required. See Section 3.1.3."
ASTTMF,Analysis Start Time Imputation Flag,Char,(TIMEFL),Cond,"The level of imputation of analysis start time. If ASTTM (or the time part of ASTDTM) was imputed, ASTTMF must be populated and is required. See Section 3.1.3."
AENDT,Analysis End Date,Num,,Perm,The end date associated with AVAL and/or AVALC. See also ASTDT.
AENTM,Analysis End Time,Num,,Perm,The end time associated with AVAL and/or AVALC. See also ASTTM.
AENDTM,"Analysis End
Datetime",Num,,Perm,The end datetime associated with AVAL and/or AVALC. See also ASTDTM.
AENDY,Analysis End Relative Day,Num,,Perm,"The number of days from an anchor date (not necessarily DM.RFSTDTC) to AENDT. See Section
3.1.2."
AENDTF,"Analysis End Date
Imputation Flag",Char,(DATEFL),Cond,"The level of imputation of analysis end date. If AENDT (or the date part of AENDTM) was
imputed, AENDTF must be populated and is required. See Section 3.1.3."
AENTMF,Analysis End Time Imputation Flag,Char,(TIMEFL),Cond,"The level of imputation of analysis end time. If AENTM (or the time part of AENDTM) was imputed, AENTMF must be populated and is required. See Section 3.1.3."
AVISIT,Analysis Visit,Char,,Cond,"The analysis visit description; required if an analysis is done by nominal, assigned or analysis visit. AVISIT may contain the visit names as observed (i.e., from SDTM VISIT), derived visit names, time window names, conceptual descriptions (such as Average, Endpoint, etc.), or a combination of any of these. AVISIT is a derived field and does not have to map to VISIT from the SDTM. AVISIT represents the analysis visit of the record, but it does not mean that the record was analyzed. There are often multiple records for the same subject and parameter that have the same value of AVISIT. ANLzzFL and other variables may be needed to identify the records selected for any given analysis. See Section 3.3.8 for information about flag variables. AVISIT should be unique for a given analysis visit window. In the event that a record does not fall within any predefined analysis timepoint window, AVISIT can be populated in any way that the producer chooses to indicate this fact (i.e., blank or “Not Windowed”). The way that AVISIT is calculated, including the variables used in its derivation, should be indicated in the variable metadata for AVISIT. The values and the rules for deriving AVISIT may be different for different parameters within the same dataset. Values of AVISIT are producer-defined, and are often directly usable in
Clinical Study Report displays."
AVISITN,Analysis Visit (N),Num,,Perm,"A numeric representation of AVISIT. Since study visits are usually defined by certain timepoints, defining AVISITN so that it represents the timepoint associated with the visit can facilitate plotting and interpretation of the values. Alternatively, AVISITN may be a protocol visit number, a cycle number, an analysis visit number, or any other number logically related to AVISIT or useful for sorting that is needed for analysis.
Within a parameter, there is a one-to-one mapping between AVISITN and AVISIT so that AVISITN has the same value for each distinct AVISIT. (Best practice would dictate that the mapping would be one-to-one within a study, but that is not an ADaM requirement.) In the event that a record does not fall within any predefined analysis timepoint window, AVISITN can be
populated in any way that the producer chooses to indicate this fact (e.g., may be null). Values of AVISITN are producer-defined."
ATPT,Analysis Timepoint,Char,,Cond,"The analysis timepoint description; required if an analysis is done by nominal, assigned or analysis timepoint (instead of or in addition to by-visit). Timepoints are relative to ATPTREF. ATPT may contain the timepoint names as observed (i.e., from SDTM --TPT), derived timepoint names, time window names, conceptual descriptions (such as Average, Endpoint, etc.), or a combination of any of these. This variable is often used in conjunction with AVISIT. ATPT represents the analysis timepoint of the record.
ATPT can be within an analysis visit (e.g., blood pressure assessments at 10 min, 20 min, and 30 min post-dose at AVISIT=Week 1) or can be unrelated to AVISIT (e.g., migraine symptoms 30 min, 60 min, and 120 min post-dose for attack 1).
The way that ATPT is calculated, including the variables used in its derivation, should be indicated in the variable metadata for ATPT. The values and the rules for deriving ATPT may be different for different parameters within the same dataset. Values of ATPT are producer-defined, and are often
directly usable in Clinical Study Report displays."
ATPTN,Analysis Timepoint (N),Num,,Perm,"ATPTN provides a numeric representation of ATPT. Defining ATPTN so that its values represent the planned timepoints (e.g., minutes or hours after dosing) is not required but can facilitate plotting and interpretation of the values. Within the same parameter, there is a one-to-one mapping between ATPT and ATPTN. (Best practice would dictate that the mapping would be one-to-one within a
study, but that is not an ADaM requirement.)"
ATPTREF,"Analysis Timepoint
Reference",Char,,Perm,"Description of the fixed reference point referred to by ATPT/ATPTN (e.g., time of dose)."
APHASE,Phase,Char,,Perm,"APHASE is a categorization of timing within a study, for example a higher-level categorization of
APERIOD or an analysis epoch. For example, APHASE could describe spans of time for SCREENING, ON TREATMENT, and FOLLOW-UP."
APHASEN,Phase (N),Num,,Perm,"APHASEN provides a numeric representation of APHASE. Within a study, there is a one-to-one
mapping between APHASE and APHASEN."
APERIOD,Period,Num,,Perm,APERIOD is a record-level timing variable that represents the analysis period within the study associated with the record for analysis purposes. The value of APERIOD (if populated) must be one of the xx values found in the ADSL TRTxxP variables.
APERIODC,Period (C),Char,,Perm,"Text characterizing to which analysis period the record belongs. One-to-one mapping within a
dataset to APERIOD."
ASPER,"Subperiod within
Period",Num,,Perm,"The numeric value characterizing a sublevel within APERIOD to which the record belongs. Within
each APERIOD, the first ASPER is 1 (i.e., it resets to 1 when the APERIOD value changes)."
ASPERC,Subperiod within Period (C),Char,,Perm,Text characterizing to which subperiod the record belongs. One-to-one mapping within a period to ASPER.
ARELTM,Analysis Relative Time,Num,,Perm,"The time relative to an anchor time. The amount of time from an anchor time to ATM. When
ARELTM is present, the anchor time variable and ARELTMU must also be included in the dataset, and the anchor time variable must be identified in the metadata for ARELTM."
ARELTMU,"Analysis Relative
Time Unit",Char,,Perm,"The units of ARELTM. For example, “HOURS” or “MINUTES.” ARELTMU is required if
ARELTM is present."
