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A This is an example of a patient visual analog scale (VAS)- craving assessment was used to assess assess  the level of craving based on response to the question “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.

This is an example of the representation of a patient VAS for evaluating the severity of itching and the impact of psoriasis symptoms on daily life. These are only examples and sponsors may use other assessments.

The Findings About Events or Interventions (FA) domain was used for the assessment of signs and symptomscraving.  Sponsors Sponsors 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 FACE dataset was used. The psoriasis condition (including symptoms) craving itself is considered a clinical event, whereas the evaluation of signs and symptoms craving at specific time points are considered findings about the clinical event.  A parent record in the CE domain is not required.

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Dataset wrap
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Rowcaps
Rows 1-2:Show 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.
Rows 3-4:Show the disease QOL VAS for subject 001 at baseline and visit 12.


Dataset2
FALOCSKINSKIN
RowSTUDYIDDOMAINUSUBJIDFASEQFATESTCDFATESTFAOBJFACATFAORRESFAORRESUFASTRESCFASTRESUFAMETHODFALOBXFLFAEVALVISITNUMFADTCFAEVLINT
FAANTXLOFAANVLLOFAANTXHIFAANVLHI
1PS006FA0011SEVSEVERITY/INTENSITYITCHINGCRAVING

PSORIASIS SYMPTOM  SYMPTOM ASSESSMENTS

988mm898mmNUMERIC RATING SCALE 11-POINTYPATIENT1

2015-06-15

-P24H
No ItchNO CRAVING 0Worst Itch ImaginableSTRONG CRAVING10010
2PS006FA0012SEVSEVERITY/INTENSITYITCHINGCRAVING PSORIASIS SYMPTOM  SYMPTOM ASSESSMENTS243mm243mmNUMERIC RATING SCALE 11-POINT
PATIENT122016-07-15-P24H
No ItchNO CRAVING 0Worst Itch Imaginable103PS006FA0013QOLIMPQOL IMPACTPSORIASISQOL ASSESSMENTS45mm45mmVISUAL ANALOG SCALE (50 MM)YPATIENT1

2015-06-15

-P7DNo Influence0A lot of Influence50STRONG CRAVING1004PS006FA0014QOLIMPQOL IMPACTPSORIASISQOL ASSESSMENTS20mm20mmVISUAL ANALOG SCALE (50 MM)PATIENT122016-07-15-P7DNo Influence0A lot of Influence50
Nsvmeta
DomainFA
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/--TESTCDCRF