In this example, a subject's weight was collected at various points in time to evaluate the presence of cachexia. An estimate of the weight of the subject approximately 3 months prior to the initial pancreatic cancer diagnosis date was collected for use at baseline.
The Vital Signs (VS) domain is used to represent the subject's weight. (For simplicity, only the weight for 1 subject is included.) When the date of the weight measurement was based on subject recall, VSDTC and VSDY were not populated. If the actual date of the weight measurement was available, VSDTC and VSDY should be populated. VSEVINTX was used to represent the timing of the baseline weight. VSEVINTX was used because the interval for evaluation cannot be represented in a standardized ISO character format (See Section 1.3, Known Issues, for additional information).
Shows the weight of the subject about 3 months prior to the initial pancreatic cancer diagnosis date. This weight was provided by the subject based on his/her recall, as a measurement was not available in the medical record.
Show the subject's weight at weeks 0, 2, and 4. The source of these weights was the subject's medical record.
|1||PACA010||VS||1000||1||WEIGHT||Weight||70.3||kg||70.3||70.3||kg||1||SCREENING||APPROXIMATELY 3 MONTHS BEFORE DX OF PANCREATIC CANCER||SUBJECT RECALL|
|2||PACA010||VS||1000||2||WEIGHT||Weight||54.4||kg||54.4||54.4||kg||2||WEEK 0||2020-06-20||1||MEDICAL RECORD|
|3||PACA010||VS||1000||3||WEIGHT||Weight||53.5||kg||53.5||53.5||kg||3||WEEK 2||2020-07-04||15||MEDICAL RECORD|
|4||PACA010||VS||1000||4||WEIGHT||Weight||50.8||kg||50.8||50.8||kg||4||WEEK 4||2020-07-18||29||MEDICAL RECORD|
VS NSV Metadata
|VSSOURCE||Source of Information||Text||Non-standard Record Qualifier||CRF|