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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 to represent the assessment of craving. Applicants may represent findings data in a single FA dataset or split the FA domain into separate datasets, following the guidance in the guide. In this example, a FACE dataset was used, indicating these 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
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Row 1:Shows the craving VAS for subject 001 at baseline 
Row 2: 

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

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RowSTUDYIDDOMAINUSUBJIDFASEQFATESTCDFATESTFAOBJFACATFAORRESFAORRESUFASTRESCFASTRESNFASTRESUFAMETHODFAEVALVISITNUMFADTCFAEVLINT
1TGI400FA0011SEVSEVERITY/INTENSITYCRAVING

SYMPTOM ASSESSMENT

98mm9898mmVISUAL ANALOG SCALE (100 MM)STUDY SUBJECT1

2015-06-15

-P24H
2

TGI400

FA0012SEVSEVERITY/INTENSITYCRAVINGSYMPTOM ASSESSMENT43mm4343mmVISUAL ANALOG SCALE (100 MM)STUDY SUBJECT122016-07-15-P24H



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