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A visual analog scale (VAS)-craving assessment was 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.

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 symptoms. 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) is considered a clinical event, whereas the evaluation of signs and symptoms at specific time points are considered findings about the clinical event. A parent record in the 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."

Rows 1-2:Show the Itching 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.

fa.xpt

face.xpt

RowSTUDYIDDOMAINUSUBJIDFASEQFATESTCDFATESTFAOBJFACATFAORRESFAORRESUFASTRESCFASTRESUFALOCFAMETHODFALOBXFLFAEVALVISITNUMFADTCFAEVLINT
FAANTXLOFAANVLLOFAANTXHIFAANVLHI
1PS006FA0011SEVSEVERITY/INTENSITYITCHING

PSORIASIS SYMPTOM ASSESSMENTS

8
8
SKINNUMERIC RATING SCALE 11-POINTYPATIENT1

2015-06-15

-P24H
No Itch0Worst Itch Imaginable10
2PS006FA0012SEVSEVERITY/INTENSITYITCHINGPSORIASIS SYMPTOM ASSESSMENTS2
2
SKINNUMERIC RATING SCALE 11-POINT
PATIENT122016-07-15-P24H
No Itch0Worst Itch Imaginable10
3PS006FA0013QOLIMPQOL IMPACTPSORIASISQOL ASSESSMENTS45mm45mm
VISUAL ANALOG SCALE (50 MM)YPATIENT1

2015-06-15

-P7D
No Influence0A lot of Influence50
4PS006FA0014QOLIMPQOL IMPACTPSORIASISQOL ASSESSMENTS20mm20mm
VISUAL ANALOG SCALE (50 MM)
PATIENT122016-07-15-P7D
No Influence0A lot of Influence50
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FA NSV Metadata

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