Tumor Results Analysis for Oncology
Format
A data frame with 99 columns:
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- SUBJID
Subject Identifier for the Study
- SITEID
Study Site Identifier
- COUNTRY
Country
- DOMAIN
Domain Abbreviation
- RFSTDTC
Subject Reference Start Date/Time
- RFENDTC
Subject Reference End Date/Time
- RFXSTDTC
Date/Time of First Study Treatment
- RFXENDTC
Date/Time of Last Study Treatment
- RFPENDTC
Date/Time of End of Participation
- SCRFDT
Screen Failure Date
- FRVDT
Final Retrieval Visit Date
- DTHDTC
Date/Time of Death
- DTHADY
Relative Day of Death
- DTHFL
Subject Death Flag
- LDDTHELD
Elapsed Days from Last Dose to Death
- LDDTHGR1
Last Dose to Death - Days Elapsed Grp 1
- DTH30FL
Death Within 30 Days of Last Trt Flag
- DTHA30FL
Death After 30 Days from Last Trt Flag
- DTHDOM
Domain for Date of Death Collection
- DTHB30FL
Death Within 30 Days of First Trt Flag
- ASEQ
Analysis Sequence Number
- REGION1
Geographic Region 1
- DMDTC
Date/Time of Collection
- DMDY
Study Day of Collection
- AGE
Age
- AGEU
Age Units
- AGEGR1
Pooled Age Group 1
- SEX
Sex
- RACE
Race
- RACEGR1
Pooled Race Group 1
- ETHNIC
Ethnicity
- SAFFL
Safety Population Flag
- PDFL
Pharmacodynamic Analysis Set Flag
- ARM
Description of Planned Arm
- ARMCD
Planned Arm Code
- ACTARM
Description of Actual Arm
- ACTARMCD
Actual Arm Code
- TRT01P
Planned Treatment for Period 01
- TRT01A
Actual Treatment for Period 01
- TRTSDT
Date of First Exposure to Treatment
- TRTSDTM
Datetime of First Exposure to Treatment
- TRTSTMF
Time of First Exposure Imput. Flag
- TRTEDT
Date of Last Exposure to Treatment
- TRTEDTM
Datetime of Last Exposure to Treatment
- TRTETMF
Time of Last Exposure Imput. Flag
- EOSSTT
End of Study Status
- EOSDT
End of Study Date
- RFICDTC
Date/Time of Informed Consent
- RANDDT
Date of Randomization
- LSTALVDT
Date Last Known Alive
- TRTDURD
Total Treatment Duration (Days)
- DTHDT
Date of Death
- DTHCAUS
Cause of Death
- DTHCGR1
Cause of Death Reason 1
- ADT
Analysis Date
- ADY
Analysis Relative Day
- ADTF
Analysis Date Imputation Flag
- AVISIT
Analysis Visit
- AVISITN
Analysis Visit (N)
- PARAM
Parameter
- PARAMCD
Parameter Code
- PARCAT1
Parameter Category 1
- PARCAT2
Parameter Category 2
- PARCAT3
Parameter Category 3
- AVAL
Analysis Value
- BASE
Baseline Value
- CHG
Change from Baseline
- PCHG
Percent Change from Baseline
- NADIR
NADIR
- CHGNAD
Change from NADIR
- PCHGNAD
Percent Change from NADIR
- ABLFL
Baseline Record Flag
- ANL01FL
Analysis Flag 01
- ANL02FL
Analysis Flag 02
- ANL03FL
Analysis Flag 03
- ANL04FL
Analysis Flag 04
- TRSEQ
Sequence Number
- TRGRPID
Group ID
- TRLNKID
Link ID
- TRTESTCD
Tumor/Lesion Assessment Short Name
- TRTEST
Tumor/Lesion Assessment Test Name
- TRORRES
Result or Finding in Original Units
- TRORRESU
Original Units
- TRSTRESC
Character Result/Finding in Std Format
- TRSTRESN
Numeric Result/Finding in Standard Units
- TRSTRESU
Standard Units
- TREVAL
Evaluator
- TREVALID
Evaluator Identifier
- TRACPTFL
Accepted Record Flag
- VISITNUM
Visit Number
- VISIT
Visit Name
- TRDTC
Date/Time of Tumor/Lesion Measurement
- TULOC
Location of the Tumor/Lesion
- TULOCGR1
Tumor Site Group 1
- LSEXP
Lesion IDs Expected
- LSASS
Lesion IDs Assessed
- DTHDTF
Date of Death Imputation Flag
Details
Contains a set of 11 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| LDIAM1 | Target Lesion 1 Analysis Diameter |
| LDIAM2 | Target Lesion 2 Analysis Diameter |
| LDIAM3 | Target Lesion 3 Analysis Diameter |
| LDIAM4 | Target Lesion 4 Analysis Diameter |
| LDIAM5 | Target Lesion 5 Analysis Diameter |
| NLDIAM1 | Target Lesion 1 Analysis Perpendicular |
| NLDIAM2 | Target Lesion 2 Analysis Perpendicular |
| NLDIAM3 | Target Lesion 3 Analysis Perpendicular |
| NLDIAM4 | Target Lesion 4 Analysis Perpendicular |
| NLDIAM5 | Target Lesion 5 Analysis Perpendicular |
| SDIAM | Target Lesions Sum of Diameters by Investigator |
Examples
data("adtr_onco")