Page History

This is an example of a patient 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 for 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 SDTMIG. In this example, an 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.