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A visual analog scale (VAS)-craving assessment was This is an example of a single-item 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.

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The Findings About Events or Interventions ( FA ) domain was used for to represent the assessment of signs and symptomscraving.  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. The psoriasis condition (including symptoms) , indicating that data are findings about clinical events. The craving itself is considered a clinical event, whereas the evaluation of signs and symptoms 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.

  • The severity of itching is rated using an 11-point numerical scale of 0-10, with 0 = "No Itching" and 10 = "Worst Itch Imaginable." No descriptions were provided for the other numbers. Subjects circled the number which best described their itching in the last 24 hours. 
  • The impact of psoriasis symptoms on quality of life (QOL) is assessed using a VAS scale of 50 mm, where the subject rates the impact from "No Influence" to "A Lot of Influence."
FAANVLHI
Dataset wrap
Nameface
Rowcaps
Rows Row 1-2:Show Shows the Itching craving VAS for subject 001 at baseline and visit 12. Medical terminology was used to define the symptom of interest in FAOBJ. FACAT is populated with the CRF page name.baseline 
Row 2: 

Shows the craving

Rows 3-4:

Show the disease QOL VAS for subject 001 at baseline and visit 12. 

Dataset2
RowSTUDYIDDOMAINUSUBJIDFASEQFATESTCDFATESTFAOBJFACATFAORRESFAORRESUFASTRESCFASTRESNFASTRESU
FALOC
FAMETHOD
FALOBXFL
FAEVALVISITNUMFADTCFAEVLINT
FAANTXLOFAANVLLOFAANTXHI
1
PS006
TGI400FA0011SEVSEVERITY/INTENSITY
ITCHING
CRAVING
PSORIASIS

SYMPTOM

ASSESSMENTS88SKINNUMERIC RATING SCALE 11-POINTYPATIENT

ASSESSMENT

98mm9898mmVISUAL ANALOG SCALE (100 MM)STUDY SUBJECT1

2015-06-15

-P24H
No Itch0Worst Itch Imaginable10
2
PS006

TGI400

FA0012SEVSEVERITY/INTENSITY
ITCHING
CRAVING
PSORIASIS
SYMPTOM
ASSESSMENTS22SKINNUMERIC RATING SCALE 11-POINTPATIENT
ASSESSMENT43mm4343mmVISUAL ANALOG SCALE (100 MM)STUDY SUBJECT122016-07-15-P24H
No Itch0Worst Itch Imaginable103PS006FA0013QOLIMPQOL IMPACTPSORIASISQOL ASSESSMENTS45mm45mmVISUAL ANALOG SCALE (50 MM)YPATIENT1

2015-06-15

-P7DNo Influence0A lot of Influence504PS006FA0014QOLIMPQOL IMPACTPSORIASISQOL ASSESSMENTS20mm20mmVISUAL ANALOG SCALE (50 MM)PATIENT122016-07-15-P7DNo Influence0A lot of Influence50

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