Page History

1. The TF domain captures the post-mortem tumor findings of the study. Records in this domain are a subset of records in the Microscopic Findings (MI) domain.
2. This domain is necessary if the SEND datasets are the basis for creation of the tumor.xpt dataset (as described in the FDA Study Data Technical Conformance Guide). See Appendix C, Mapping to Tumor xpt File.
3. One subject may have multiple records for any organ, if multiple tumors were found.
4. The TFDETECT variable is the number of days relative to the first day of treatment product exposure when the tumor was first detected. Depending on how the tumor was detected, this could be derived from CLDTC, PMDTC, or DSSTDTC.
   1. If the tumor was detected as a clinical sign, then TFDETECT is based on the Clinical Observations (CL) domain start date/time of observation variable (CLDTC). This is calculated as (CLDTC – EXSTDTC) + 1.
   2. If the tumor was detected as a palpable mass, then TFDETECT is based on the Palpable Masses (PM) domain start date/time of observation variable (PMDTC). This is calculated as (PMDTC – EXSTDTC) + 1.
   3. If the tumor was initially detected during necropsy (the MA domain), then TFDETECT is based on the Disposition (DS) domain start date/time of observation variable (DSSTDTC). This is calculated as (DSSTDTC – EXSTDTC) + 1.
   4. If the tumor was initially detected during histopathology examination (the MI domain), then TFDETECT is based off the DS domain variable DSSTDTC. This is calculated as (DSSTDTC – EXSTDTC) + 1.
5. The TFSPID variable is intended to reflect the mass identification. This variable should be used to link in-life findings with pathology findings. The mass identifier in --SPID should be consistent across domains (CL, PM, MA, MI, and TF).

...