Illustrates Domains
PR
Illustrates Variables
PRINDC
PRLOC
PRPLDUIC
PRTRTSTT
Content
| Row 1: | Shows that Subject 010 received brachytherapy. The sponsor did not collect details about each treatment session/fraction or the dose. Because radiation was targeted to the liver and body of the panaceas, PRLOC is assigned "MULTIPLE" and the NSVs PRLOC1 and PRLOC2 are used to report each location. |
|---|---|
| Row 2: | Shows that Subject 011 was to receive stereotactic body radiation therapy once a week with a planned intervention course of 5 weeks. PRSTDTC and PRENDTC show that the actual therapy was given over 6 weeks. (Alternatively, a sponsor may include a row for the treatment given on each of the 5 days of treatment). |
| Row 3: | Shows that Subject 012 received stereotactic body radiation therapy daily, with a planned intervention course of 5 days. |
| Row 4: | Shows that Subject 013 received intraoperative radiation therapy during the surgery to resect the tumor in the pancreas. |
| Row 5: | Shows that Subject 014 had intensity-modulated radiation therapy administered 5 times a week, with a planned intervention course of 5 weeks. |
pr.xpt
Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRTRT | PRDECOD | PRCAT | PRINDC | PRDOSE | PRDOSU | PRDOSFRQ | PRLOC | PRSTDTC | PRENDTC | PRPLDUIC | PRTRTSTT | PRLOC1 | PRLOC2 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | PACA004 | PR | 010 | 1 | Brachytherapy | Radiotherapy | PANCREATIC CANCER RELATED RADIATION | PANCREATIC CANCER | MULTIPLE | 2014-06 | 2014-09 | METASTATIC | LIVER | PANCREAS, BODY | |||||
2 | PACA004 | PR | 011 | 1 | Stereotactic Body Radiation Therapy | Radiotherapy | PANCREATIC CANCER RELATED RADIATION | PANCREATIC CANCER | 600 | cGy | 1 TIME PER WEEK | PANCREAS, TAIL | 2013-06-10 | 2013-07-17 | P5W | LOCALLY ADVANCED | |||
3 | PACA004 | PR | 012 | 1 | Stereotactic Body Radiation Therapy | Radiotherapy | PANCREATIC CANCER RELATED RADIATION | PANCREATIC CANCER | 600 | cGy | QD | PANCREAS, TAIL | 2015-06-10 | 2015-06-14 | P5D | LOCALLY ADVANCED | |||
4 | PACA004 | PR | 013 | 1 | Intraoperative Radiation Therapy | Radiotherapy | PANCREATIC CANCER RELATED RADIATION | PANCREATIC CANCER | 1200 | cGy | ONCE | PANCREAS, HEAD | 2013-07-18 | 2013-07-18 | ADJUVANT | ||||
5 | PACA004 | PR | 014 | 1 | Intensity Modulated Radiation Therapy | Radiotherapy | PANCREATIC CANCER RELATED RADIATION | PANCREATIC CANCER | 1.8 | cGy | 5 TIMES PER WEEK | PANCREAS, BODY | 2014-06-10 | 2014-07-15 | P5W | NEO-ADJUVANT |
PR NSV Metadata
| Variable | Label | Type | Codelist | Role | Origin |
|---|---|---|---|---|---|
| PRPLDUIC | Planned Duration of Intervention Course | text | Non-standard Record Qualifier | CRF | |
PRTRTSTT | Treatment Setting | text | (TRTSET) | Non-standard Record Qualifier | CRF |
| PRLOC1 | Location of Procedure 1 | text | Non-standard Record Qualifier | CRF | |
| PRLOC2 | Location of Procedure 2 | text | Non-standard Record Qualifier | CRF |