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 tp to represent the assessment of craving. Sponsors Applicants may represent findings data in a single FA dataset or split the FA domain into separate datasets, following the guidance in the section Use of Relative Timing Variables (Copy). 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 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.
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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 Visist visit 12. |
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DomainRow | STUDYID | DOMAIN | USUBJID | FASEQ | FATESTCD | FATEST | FAOBJ | FACAT | FAORRES | FAORRESU | FASTRESC | FASTRESN | FASTRESU | FAMETHOD |
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FALOBXFL | FAEVAL | VISITNUM | FADTC | FAEVLINT |
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FAANTXLO | FAANVLLO | FAANTXHIFAANVLHI | 1 | TGI400 | FA | 001 | 1 | SEV | SEVERITY/INTENSITY | CRAVING | SYMPTOM ASSESSMENT | 98 | mm | 98 | 98 | mm | VISUAL ANALOG SCALE (100 MM) | Y | STUDY SUBJECT | 1 | 2015-06-15 | -P24H |
NO CRAVING | 0 | STRONG CRAVING | 100 | 2 | | 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 |
NO CRAVING | 0 | STRONG CRAVING | 100 | | Nsvmeta |
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| FA | Variable | Label | Type | Role | Origin |
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FAANTXLO | Anchor Text Low | text | Non-standard Variable Qualifier of --TEST/--TESTCD | CRF | FAANVLLO | Anchor Value Low | integer | Non-standard Variable Qualifier of --TEST/--TESTCD | CRF | FAANTXHI | Anchor Text High | text | Non-standard Variable Qualifier of --TEST/--TESTCD | CRF | FAANVLHI | Anchor Value High | integer | Non-standard Variable Qualifier of --TEST/--TESTCD | CRF |
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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 its 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.
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVAL |
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1 | TGI400 | FA | 001 | FASEQ | 1 | FAANTXLOAnchor Text Low | ANCHOR TEXT LOW | NO CRAVING | ASSIGNED |
| 2 | TGI400 | FA | 001 | FASEQ | 1 | FAANVLLOAnchor Value Low | ANCHOR VALUE LOW | 0 | ASSIGNED |
| 3 | TGI400 | FA | 001 | FASEQ | 1 | FAANTXHIAnchor Text High | ANCHOR TEXT HIGH | STRONG CRAVING | ASSIGNED |
| 3 | TGI400 | FA | 001 | FASEQ | 1 | FAANTXHI | FAANVLHI | ANCHOR VALUE HIGHAnchor Text High | 100 | ASSIGNED |
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