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This is an example of a patient single-item visual analog scale ( VAS )- used to assess the level of craving based on response to the question “How (i.e., the question “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 for 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 SDTMIG. In this example, an 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
Rows Row 1:Shows the craving VAS for subject 001 at baseline 
Rows Row 2

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

Dataset2
RowSTUDYIDDOMAINUSUBJIDFASEQFATESTCDFATESTFAOBJFACATFAORRESFAORRESUFASTRESCFASTRESNFASTRESUFAMETHOD
FALOBXFL
FAEVALVISITNUMFADTCFAEVLINT
FAANTXLOFAANVLLOFAANTXHIFAANVLHI
1TGI400FA0011SEVSEVERITY/INTENSITYCRAVING
 SYMPTOM ASSESSMENTS

SYMPTOM ASSESSMENT

98mm9898mmVISUAL ANALOG SCALE (100 MM)
YPATIENT
STUDY SUBJECT1

2015-06-15

-P24H
NO CRAVING 0
STRONG CRAVING100
2
PS006

TGI400

FA0012SEVSEVERITY/INTENSITY
CRAVING 
CRAVING
 SYMPTOM ASSESSMENTS
SYMPTOM ASSESSMENT43mm4343mmVISUAL ANALOG SCALE (100 MM)
PATIENT
STUDY SUBJECT122016-07-15-P24H
NO CRAVING 0STRONG CRAVING100

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 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 LOWNO CRAVINGASSIGNED
2TGI400FA001FASEQ1FAANVLLOANCHOR VALUE LOW0ASSIGNED
3TGI400FA001FASEQ1FAANTXHIANCHOR TEXT HIGHSTRONG CRAVINGASSIGNED
3TGI400FA001FASEQ1FAANVLHIANCHOR VALUE HIGH100ASSIGNED
Nsvmeta
DomainFA
CRF
VariableLabelTypeRoleOrigin
FAANTXLOAnchor Text LowtextNon-standard Variable Qualifier of --TEST/--TESTCDCRF
FAANVLLO

Anchor Value Low

integerNon-standard Variable Qualifier of --TEST/--TESTCDCRF
FAANTXHIAnchor Text HightextNon-standard Variable Qualifier of --TEST/--TESTCDCRF
FAANVLHIAnchor Value HighintegerNon-standard Variable Qualifier of --TEST/--TESTCD