A This is an example of a patient visual analog scale (VAS)- craving assessment was used to assess assess the level of craving based on response to the question “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.
This is an example of the representation of a patient VAS for evaluating the severity of itching and the impact of psoriasis symptoms on daily life. These are only examples and sponsors may use other assessments.
The Findings About Events or Interventions (FA) domain was used for the assessment of signs and symptomscraving. Sponsors 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 psoriasis condition (including symptoms) craving itself is considered a clinical event, whereas the evaluation of signs and symptoms craving at specific time points are considered findings about the clinical event. A parent record in the CE domain is not required.
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Rows 1-2: | Show 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. | 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 | FASTRESU | FALOC | FAMETHOD | FALOBXFL | FAEVAL | VISITNUM | FADTC | FAEVLINT |
| FAANTXLO | FAANVLLO | FAANTXHI | FAANVLHI |
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1 | PS006 | FA | 001 | 1 | SEV | SEVERITY/INTENSITY | ITCHINGCRAVING | PSORIASIS SYMPTOM SYMPTOM ASSESSMENTS | 988 | mm | 898 | SKINmm | NUMERIC RATING SCALE 11-POINT | Y | PATIENT | 1 | 2015-06-15 | -P24H |
| No ItchNO CRAVING | 0 | Worst Itch Imaginable | STRONG CRAVING | 10010 | 2 | PS006 | FA | 001 | 2 | SEV | SEVERITY/INTENSITY | ITCHINGCRAVING | PSORIASIS SYMPTOM SYMPTOM ASSESSMENTS2 | 43 | mm | 243 | SKINmm | NUMERIC RATING SCALE 11-POINT |
| PATIENT | 12 | 2016-07-15 | -P24H |
| No ItchNO CRAVING | 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 | STRONG CRAVING | 100 | 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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| 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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