Versions Compared

Key

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

This is an example of a single-item VAS used to assess the level of craving (i.e., 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 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. In this example, a FACE dataset was used, indicating that data are findings about clinical events. The craving itself is considered a clinical event, whereas craving at specific time points is considered findings about the clinical event. A parent record in the Clinical Events (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 at visit 12. 

Dataset2
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

This example illustrates how information on the scale scoring may be represented as supplemental qualifier variables. A record in a SUPPFA dataset relates back to the parent record(s) via the key identified by the STUDYID, RDOMAIN, USUBJID, and IDVAR/IDVARVAL variables. Here the parent domain (RDOMAIN) is FA, and IDVAR is FASEQ. QNAM holds the name of the supplemental qualifier variable being defined. 

Dataset wrap
NameSUPPFA
Dataset2
RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGQEVAL
1TGI400FA001FASEQ1FAANTXLOANCHOR TEXT LOWNO CRAVINGASSIGNED
2TGI400FA001FASEQ1FAANVLLOANCHOR VALUE LOW0ASSIGNED
3TGI400FA001FASEQ1FAANTXHIANCHOR TEXT HIGHSTRONG CRAVINGASSIGNED
3TGI400FA001FASEQ1FAANVLHIANCHOR VALUE HIGH100ASSIGNED