Tumor Response Analysis
adrs_oncoA data frame with 79 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country
Domain Abbreviation
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of End of Participation
Screen Failure Date
Final Retrieval Visit Date
Date/Time of Death
Relative Day of Death
Subject Death Flag
Elapsed Days from Last Dose to Death
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Domain for Date of Death Collection
Death Within 30 Days of First Trt Flag
Analysis Sequence Number
Geographic Region 1
Date/Time of Collection
Study Day of Collection
Age
Age Units
Pooled Age Group 1
Sex
Race
Pooled Race Group 1
Ethnicity
Safety Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
End of Study Status
End of Study Date
Date/Time of Informed Consent
Date of Randomization
Date Last Known Alive
Total Treatment Duration (Days)
Date of Death
Cause of Death
Cause of Death Reason 1
Analysis Date
Analysis Date Imputation Flag
Analysis Visit
Parameter
Parameter Code
Parameter Category 1
Parameter Category 2
Parameter Category 3
Analysis Value
Analysis Value (C)
Analysis Flag 01
Analysis Flag 02
Visit Number
Visit Name
Assessment Short Name
Assessment Name
Result or Finding in Original Units
Character Result/Finding in Std Format
Evaluator
Evaluator Identifier
Accepted Record Flag
Date/Time of Assessment
Sequence Number
Date of Death Imputation Flag
Contains a set of 13 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| BCP | Best Overall Response of CR/PR by Investigator (confirmation not required) |
| BOR | Best Overall Response by Investigator (confirmation not required) |
| CB | Clinical Benefit by Investigator (confirmation for response not required) |
| CBCP | Best Confirmed Overall Response of CR/PR by Investigator |
| CBOR | Best Confirmed Overall Response by Investigator |
| CCB | Confirmed Clinical Benefit by Investigator |
| CRSP | Confirmed Response by Investigator |
| DEATH | Death |
| LSTA | Last Disease Assessment by Investigator |
| MDIS | Measurable Disease at Baseline by Investigator |
| OVR | Overall Response by Investigator |
| PD | Disease Progression by Investigator |
| RSP | Response by Investigator (confirmation not required) |
None