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Tumor Response Analysis

Usage

adrs_onco

Format

A data frame with 79 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

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

ADTF

Analysis Date Imputation Flag

AVISIT

Analysis Visit

PARAM

Parameter

PARAMCD

Parameter Code

PARCAT1

Parameter Category 1

PARCAT2

Parameter Category 2

PARCAT3

Parameter Category 3

AVAL

Analysis Value

AVALC

Analysis Value (C)

ANL01FL

Analysis Flag 01

ANL02FL

Analysis Flag 02

VISITNUM

Visit Number

VISIT

Visit Name

RSTESTCD

Assessment Short Name

RSTEST

Assessment Name

RSORRES

Result or Finding in Original Units

RSSTRESC

Character Result/Finding in Std Format

RSEVAL

Evaluator

RSEVALID

Evaluator Identifier

RSACPTFL

Accepted Record Flag

RSDTC

Date/Time of Assessment

RSSEQ

Sequence Number

DTHDTF

Date of Death Imputation Flag

Source

Generated from admiralonco package (template ad_adrs.R).

Details

Contains a set of 13 unique Parameter Codes and Parameters:

PARAMCDPARAM
BCPBest Overall Response of CR/PR by Investigator (confirmation not required)
BORBest Overall Response by Investigator (confirmation not required)
CBClinical Benefit by Investigator (confirmation for response not required)
CBCPBest Confirmed Overall Response of CR/PR by Investigator
CBORBest Confirmed Overall Response by Investigator
CCBConfirmed Clinical Benefit by Investigator
CRSPConfirmed Response by Investigator
DEATHDeath
LSTALast Disease Assessment by Investigator
MDISMeasurable Disease at Baseline by Investigator
OVROverall Response by Investigator
PDDisease Progression by Investigator
RSPResponse by Investigator (confirmation not required)

References

None

Examples

data("adrs_onco")