A visual analog scale (VAS)-craving assessment was This is an example of a single-item VAS used to assess the level of craving based on response to the question “How (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.
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The Findings About Events or Interventions ( FA ) domain was used for to represent the assessment of signs and symptomscraving. Sponsors Applicants 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 a FACE dataset was used. The psoriasis condition (including symptoms) , indicating that data are findings about clinical events. The craving itself is considered a clinical event, whereas the evaluation of signs and symptoms 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.
- 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."
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Rows Row 1-2: | Show Shows the Itching craving 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.baseline | Row 2: | | Rows 3-4: | Show the disease QOL VAS for subject 001 at baseline and visit 12. |
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Row | STUDYID | DOMAIN | USUBJID | FASEQ | FATESTCD | FATEST | FAOBJ | FACAT | FAORRES | FAORRESU | FASTRESC | FASTRESN | FASTRESU |
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FALOCFALOBXFL | FAEVAL | VISITNUM | FADTC | FAEVLINT |
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FAANTXLO | FAANVLLO | FAANTXHI | FAANVLHIPS006TGI400 | FA | 001 | 1 | SEV | SEVERITY/INTENSITY | ITCHINGPSORIASIS ASSESSMENTS8 | 8 | SKIN | NUMERIC RATING SCALE 11-POINT | Y | PATIENTASSESSMENT | 98 | mm | 98 | 98 | mm | VISUAL ANALOG SCALE (100 MM) | STUDY SUBJECT | 1 | 2015-06-15 | -P24H |
No Itch | 0 | Worst Itch Imaginable | 10 | PS006 | FA | 001 | 2 | SEV | SEVERITY/INTENSITY | ITCHINGPSORIASIS ASSESSMENTS2 | 2 | SKIN | NUMERIC RATING SCALE 11-POINT | PATIENTASSESSMENT | 43 | mm | 43 | 43 | mm | VISUAL ANALOG SCALE (100 MM) | STUDY SUBJECT | 12 | 2016-07-15 | -P24H |
No Itch | 0 | Worst Itch Imaginable | 10 | 3 | PS006 | FA | 001 | 3 | QOLIMP | QOL IMPACT | PSORIASIS | QOL ASSESSMENTS | 45 | mm | 45 | mm | VISUAL ANALOG SCALE (50 MM) | Y | PATIENT | 1 | | -P7D | No Influence | 0 | A lot of Influence | 50 | 4 | PS006 | FA | 001 | 4 | QOLIMP | QOL IMPACT | PSORIASIS | QOL ASSESSMENTS | 20 | mm | 20 | mm | VISUAL ANALOG SCALE (50 MM) | PATIENT | 12 | 2016-07-15 | -P7D | No Influence | 0 | A lot of Influence | 50 | |
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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 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 | FAANTXLO | ANCHOR TEXT LOW | NO CRAVING | ASSIGNED |
| 2 | TGI400 | FA | 001 | FASEQ | 1 | FAANVLLO | ANCHOR VALUE LOW | 0 | ASSIGNED |
| 3 | TGI400 | FA | 001 | FASEQ | 1 | FAANTXHI | ANCHOR TEXT HIGH | STRONG CRAVING | ASSIGNED |
| 3 | TGI400 | FA | 001 | FASEQ | 1 | FAANVLHI | ANCHOR VALUE HIGH | 100 | ASSIGNED |
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| 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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