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This is an example of a single-item visual analog scale ( VAS ) used to assess the level of craving based on response to (i.e., the question “ In “In the past 24 hours, how strong is your craving for cigarettes?”) on a scale from “no craving” to “strong craving” by measuring the number of millimeters (0–100 mm) from the “no craving” dot to the point at which the drawn line intersected the scale.

The Findings About Events or Interventions ( FA ) domain was used tp to represent the assessment of craving. Sponsors Applicants may represent findings data in a single FA dataset or split the FA domain into separate datasets, following the guidance in the section Use of Relative Timing Variables (Copy). In this example, a FACE dataset was used, indicating that data are findings about clinical events. The craving itself is considered a clinical event, whereas the evaluation of craving at specific time points are is considered findings about the clinical event.   A parent record in the Clinical Events (CE) domain is not required.

Dataset wrap
Nameface
Rowcaps
Row 1:Shows the craving VAS for subject 001 at baseline 
Row 2: 

Shows the craving VAS for subject 001 at Visist visit 12. 

DomainFAANTXHI
Dataset2
RowSTUDYIDDOMAINUSUBJIDFASEQFATESTCDFATESTFAOBJFACATFAORRESFAORRESUFASTRESCFASTRESNFASTRESUFAMETHOD
FALOBXFL
FAEVALVISITNUMFADTCFAEVLINT
FAANTXLOFAANVLLO
FAANVLHI
1TGI400FA0011SEVSEVERITY/INTENSITYCRAVING

SYMPTOM ASSESSMENT

98mm9898mmVISUAL ANALOG SCALE (100 MM)
Y
STUDY SUBJECT1

2015-06-15

-P24H
NO CRAVING0STRONG CRAVING100
2

TGI400

FA0012SEVSEVERITY/INTENSITYCRAVINGSYMPTOM ASSESSMENT43mm4343mmVISUAL ANALOG SCALE (100 MM)STUDY SUBJECT122016-07-15-P24H
NO CRAVING0STRONG CRAVING100
Nsvmeta
FAVariableLabelTypeRoleOriginFAANTXLOAnchor Text LowtextNon-standard Variable Qualifier of --TEST/--TESTCDCRFFAANVLLO

Anchor Value Low

integerNon-standard Variable Qualifier of --TEST/--TESTCDCRFFAANTXHIAnchor Text HightextNon-standard Variable Qualifier of --TEST/--TESTCDCRFFAANVLHIAnchor Value HighintegerNon-standard Variable Qualifier of --TEST/--TESTCDCRF

This example illustrates how information on the scale scoring may be represented as supplemental qualifier variables. A record in a SUPPFA dataset relates back to its the parent record(s) via the key identified by the STUDYID, RDOMAIN, USUBJID, and IDVAR/IDVARVAL variables. Here the parent domain (RDOMAIN) is FA, and IDVAR is FASEQ. QNAM holds the name of the supplemental qualifier variable being defined. 

Dataset wrap
NameSUPPFA
Dataset2
RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGQEVAL
1TGI400FA001FASEQ1FAANTXLOAnchor Text LowANCHOR TEXT LOWNO CRAVINGASSIGNED
2TGI400FA001FASEQ1FAANVLLOAnchor Value LowANCHOR VALUE LOW0ASSIGNED
3TGI400FA001FASEQ1FAANTXHIAnchor Text HighANCHOR TEXT HIGHSTRONG CRAVINGASSIGNED
3TGI400FA001FASEQ1FAANTXHIFAANVLHIANCHOR VALUE HIGHAnchor Text High100ASSIGNED

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