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If analysis timepoints are defined by relative day or hour windows, then the variables in the table below may be used along with ADY or ARELTM to clarify how the record representing each analysis timepoint was chosen from among the possible candidates. The record chosen is indicated by the analyzed record flag ANLzzFL (see Indicator Variables for BDS Datasets). Note that the variables in table below may not be applicable in all situations and are presented as an option.
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Variable Name | Variable Label | Type | Codelist/ Controlled Terms | Core | CDISC Notes |
AWRANGE | Analysis Window Valid Relative Range | Char | Perm | The range of values that are valid for a given analysis timepoint (a given value of AVISIT). For example, "5-9 DAYS". | |
AWTARGET | Analysis Window Target | Num | Perm | The target or most desired analysis relative day (ADY) value or analysis relative time (ARELTM) value for a given value of AVISIT. | |
AWTDIFF | Analysis Window Diff from Target | Num | Perm | Absolute difference between ADY or ARELTM and AWTARGET. It will be necessary to adjust for the fact that there is no Day 0 in the event that ADY and AWTARGET are not of the same sign. If the sign of the difference is important, then AWTDIFF might have to be used in conjunction with ADY or ARELTM and possibly AWTARGET when choosing among records. | |
AWLO | Analysis Window Beginning Timepoint | Num | Perm | The value of the beginning timepoint (inclusive) needs to be used in conjunction to AWRANGE. For example, if AWRANGE is "5-9 DAYS", then AWLO is "5". | |
AWHI | Analysis Window Ending Timepoint | Num | Perm | The value of the ending timepoint (inclusive) needs to be used in conjunction to AWRANGE. For example, if AWRANGE is "5-9 DAYS", then AWHI is "9". | |
AWU | Analysis Window Unit | Char | Perm | Unit used for AWTARGET, AWTDIFF, AWLO and AWHI. Examples: DAYS, HOURS. |
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