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.
Row 1:
Shows the craving VAS for subject 001 at baseline
Row 2:
Shows the craving VAS for subject 001 at visit 12.
fa.xpt
face.xpt
Row
STUDYID
DOMAIN
USUBJID
FASEQ
FATESTCD
FATEST
FAOBJ
FACAT
FAORRES
FAORRESU
FASTRESC
FASTRESN
FASTRESU
FAMETHOD
FAEVAL
VISITNUM
FADTC
FAEVLINT
1
TGI400
FA
001
1
SEV
SEVERITY/INTENSITY
CRAVING
SYMPTOM ASSESSMENT
98
mm
98
98
mm
VISUAL ANALOG SCALE (100 MM)
STUDY SUBJECT
1
2015-06-15
-P24H
2
TGI400
FA
001
2
SEV
SEVERITY/INTENSITY
CRAVING
SYMPTOM ASSESSMENT
43
mm
43
43
mm
VISUAL ANALOG SCALE (100 MM)
STUDY SUBJECT
12
2016-07-15
-P24H
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Please add a row column to your dataset.
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.