Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Panel

This  needs to be discussed with QRS team. This is following the rules developed for single item VAS in Psoriasis 

This is an example of a patient single item visual analog scale (VAS)- used to assess the level of craving based on response to 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.

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.


Dataset wrap
Nameface
Rowcaps
Row 1:Shows the craving VAS for subject 001 at baseline 
Row 2: 

Shows the craving VAS for subject 001 atVisist 12. 

Dataset2
RowSTUDYIDDOMAINUSUBJIDFASEQFATESTCDFATESTFAOBJFACATFAORRESFAORRESUFASTRESCFASTRESUFAMETHODFALOBXFLFAEVALVISITNUMFADTCFAEVLINT
FAANTXLOFAANVLLOFAANTXHIFAANVLHI
1TGI400FA0011SEVSEVERITY/INTENSITYCRAVING

SYMPTOM ASSESSMENT

98mm98mmVISUAL ANALOG SCALE (100 MM)YPATIENT1

2015-06-15

-P24H
NO CRAVING0STRONG CRAVING100
2

TGI400

FA0012SEVSEVERITY/INTENSITYCRAVINGSYMPTOM ASSESSMENT43mm43mmVISUAL ANALOG SCALE (100 MM)
PATIENT122016-07-15-P24H
NO CRAVING0STRONG CRAVING100
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