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, Timing Variable�Conventions."
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, Date마nd Time�Imputation�Flag�Variables."
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, Date마nd Time�Imputation�Flag�Variables."
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, Timing Variable�Conventions."
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, Date마nd�Time�Imputation�Flag�Variables."
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, Date마nd�Time�Imputation�Flag�Variables."
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, Timing Variable�Conventions."
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, Date마nd�Time�Imputation�Flag�Variables."
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, Date마nd�Time�Imputation�Flag�Variables."
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, Indicator�Variables맍or�BDS�Datasets, 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 (e.g., 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,"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.
There must be a one-to-one relationship between AVISITN and AVISIT (i.e., AVISITN has the same value for each distinct AVISIT) within a parameter. A best practice is to extend the one-to-one relationship to within a study, but this 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.
AVISITN cannot be present unless AVISIT is also present. On a given record, AVISITN cannot be populated if AVISIT is null. AVISITN can be null when AVISIT is populated, as long as the one-to-one relationship is maintained within a parameter on all rows on which both variables are populated."
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,"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. There must be a one-to-one relationship between ATPTN and ATPT within a parameter. (Best practice would dictate that the mapping would be one-to-one within a study, but that is not an ADaM requirement.)
ATPTN cannot be present unless ATPT is also present. When ATPT and ATPTN are present, then on a given record, either both must be populated or both must be null."
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. APHASE may be used alone or in addition to APERIOD. APHASE is independent of TRTxxP within ADSL. APHASE may be populated for spans of time where a subject is not on treatment. The value of APHASE (if populated) must be one of the values found in the ADSL APHASEw variables."
APHASEN,Phase (N),Num,,Perm,"Numeric representation of APHASE. The value of APHASEN (if populated) must be one of the w values found in the ADSL APHASEw variable names. There must be a one-to-one relationship between APHASEN and APHASE within a study, which must be the same as the one-to-one mapping between w and APHASEw in ADSL.
APHASEN cannot be present unless APHASE is also present. When APHASE and APHASEN are present, then on a given record, either both must be populated or both must be null."
APERIOD,Period,Num,,Cond,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 variable names. APERIOD is required if ASPER is present. APERIOD must be populated on all records where ASPER is populated.
APERIODC,Period (C),Char,,Perm,"Text characterizing to which analysis period the record belongs. There must be a one-to-one relationship between APERIODC and APERIOD within a study. APERIODC cannot be present unless APERIOD is also present. When APERIOD and APERIODC are present, then on a given record, either both must be populated or both must be null."
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). The value of ASPER (if populated) must be one of the w values found in the ADSL PxxSw variable names."
ASPERC,Subperiod within Period (C),Char,,Perm,"Text characterizing to which subperiod the record belongs. There must be a one-to-one relationship between ASPERC and ASPER within a value of APERIOD, which must be the same as the one-to-one mapping between PxxSw and w in ADSL, where xx is equal to the value of APERIOD. The value of ASPERC (if populated) must be one of the values found in the ADSL PxxSw variables.
ASPERC cannot be present unless ASPER is also present. When ASPER and ASPERC are present, then on a given record, either both must be populated or both must be null."
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."
