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The following table lists the non-standard variables used in this document, and gives their parent domain and variable-level metadata.

Parent DomainVariableLabelSAS Data TypeDefine-XML Data TypeCodelist/Controlled TermsRoleDescriptionNotes

FA, LB

--COLSRT

Collected Summary Result Type

Chartext

Non-Standard Variable Qualifier NUT-119 - Getting issue details... STATUS

Variable qualifier of --TESTCD and --TEST. Used to indicate the type of collected summary result (e.g., MAXIMUM, MINIMUM, MEAN, MEDIAN, NADIR). This includes source summary results collected on a CRF or provided by an external vendor (e.g., central lab). If the summary result is derived using individual source data records, this summary result should be represented in ADaM. If a sponsor has both a collected summary result and a derived summary result, the collected summary result should be represented in SDTM and the derived summary result should be represented in ADaM.

FA, LB

--SOURCE NUT-103 - Getting issue details... STATUS Source of DataChartext
Non-Standard Record QualifierThe original source of the data such as RECALL, MEDICAL RECORD, CENTRAL LAB. This should not be confused with EVAL which describes the role of the person who provided the evaluation.
BE--SPEC

Specimen Material Type NUT-139 - Getting issue details... STATUS

ChartextSPECTYPE

Non-Standard Record Qualifier NUT-139 - Getting issue details... STATUS

Defines the type of specimen that undergoes the event. NUT-139 - Getting issue details... STATUS


EX--NADEVINumber of Administrations in Eval. Int.Numinteger
Non-Standard Record QualifierThe number of times the treatment was administered within a specific evaluation interval.
(Parenthesis indicates CDISC/NCI codelist)

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