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This is an example of a patient visual analog scale (VAS)- used to 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.

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


Rows 1-2:Show the 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: 

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RowSTUDYIDDOMAINUSUBJIDFASEQFATESTCDFATESTFAOBJFACATFAORRESFAORRESUFASTRESCFASTRESUFAMETHODFALOBXFLFAEVALVISITNUMFADTCFAEVLINT
FAANTXLOFAANVLLOFAANTXHIFAANVLHI
1PS006FA0011SEVSEVERITY/INTENSITYCRAVING

 SYMPTOM ASSESSMENTS

98mm98mmNUMERIC RATING SCALE 11-POINTYPATIENT1

2015-06-15

-P24H
NO CRAVING 0STRONG CRAVING100
2PS006FA0012SEVSEVERITY/INTENSITYCRAVING  SYMPTOM ASSESSMENTS43mm43mmNUMERIC RATING SCALE 11-POINT
PATIENT122016-07-15-P24H
NO CRAVING 0STRONG CRAVING100

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FA NSV Metadata

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