| Title: | J&J Innovative Medicine ADaM Test Data |
| Version: | 0.0.1 |
| Description: | A set of Analysis Data Model (ADaM) datasets constructed by modifying the ADaM datasets in the 'pharmaverseadam' package to meet J&J Innovative Medicine's standard data structure for Clinical and Statistical Programming. |
| License: | Apache License (≥ 2) |
| Encoding: | UTF-8 |
| LazyData: | true |
| RoxygenNote: | 7.3.2 |
| Language: | en-US |
| Depends: | R (≥ 3.5), pharmaverseadam |
| NeedsCompilation: | no |
| Packaged: | 2025-07-10 16:20:07 UTC; DTord |
| Author: | David Munoz Tord [aut, cre], Nicholas Masel [aut], Joe Kovach [aut], Mahesh Divakaran [ctb], J&J Innovative Medicine [cph, fnd] |
| Maintainer: | David Munoz Tord <david.munoztord@mailbox.org> |
| Repository: | CRAN |
| Date/Publication: | 2025-07-15 11:40:08 UTC |
pharmaverseadamjnj: J&J Innovative Medicine ADaM Test Data
Description
A set of Analysis Data Model (ADaM) datasets constructed by modifying the ADaM datasets in the 'pharmaverseadam' package to meet J&J Innovative Medicine's standard data structure for Clinical and Statistical Programming.
Author(s)
Maintainer: David Munoz Tord david.munoztord@mailbox.org
Authors:
Nicholas Masel nmasel@its.jnj.com
Joe Kovach jkovach2@its.jnj.com
Other contributors:
Mahesh Divakaran mdivaka2@its.jnj.com [contributor]
J&J Innovative Medicine [copyright holder, funder]
adae
Description
adae modified from pharmaverseadam
Usage
adae
Format
A data frame with 1191 rows and 78 variables:
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- AESEQ
Sequence Number
- AESPID
Sponsor-Defined Identifier
- AETERM
Reported Term for the Adverse Event
- AELLT
Lowest Level Term
- AELLTCD
Lowest Level Term Code
- AEDECOD
Dictionary-Derived Term
- AEPTCD
Preferred Term Code
- AEHLT
High Level Term
- AEHLTCD
High Level Term Code
- AEHLGT
High Level Group Term
- AEHLGTCD
High Level Group Term Code
- AEBODSYS
Body System or Organ Class
- AEBDSYCD
Body System or Organ Class Code
- AESOC
Primary System Organ Class
- AESOCCD
Primary System Organ Class Code
- AESEV
Severity/Intensity
- AESER
Serious Event
- AEACN
Action Taken with Study Treatment
- AEREL
Causality
- AEOUT
Outcome of Adverse Event
- AESCAN
Involves Cancer
- AESCONG
Congenital Anomaly or Birth Defect
- AESDISAB
Persist or Signif Disability/Incapacity
- AESDTH
Results in Death
- AESHOSP
Requires or Prolongs Hospitalization
- AESLIFE
Is Life Threatening
- AESOD
Occurred with Overdose
- AEDTC
Date/Time of Collection
- AESTDTC
Start Date/Time of Adverse Event
- AEENDTC
End Date/Time of Adverse Event
- AESTDY
Study Day of Start of Adverse Event
- AEENDY
Study Day of End of Adverse Event
- ASTDTM
Analysis Start Date/Time
- ASTDTF
Analysis Start Date Imputation Flag
- ASTTMF
Analysis Start Time Imputation Flag
- AENDTM
Analysis End Date/Time
- AENDTF
Analysis End Date Imputation Flag
- AENTMF
Analysis End Time Imputation Flag
- ASTDT
Analysis Start Date
- AENDT
Analysis End Date
- ASTDY
Analysis Start Relative Day
- AENDY
Analysis End Relative Day
- ADURN
Analysis Duration (N)
- ADURU
Analysis Duration Units
- LDOSEDTM
End Date/Time of Last Dose
- ASEV
Analysis Severity/Intensity
- AREL
Analysis Causality
- TRTEMFL
Treatment Emergent Analysis Flag
- ASEVN
Analysis Severity/Intensity (N)
- AOCCIFL
1st Max Sev./Int. Occurrence Flag
- AETOXGR
Standard Toxicity Grade
- AETOXGRN
Standard Toxicity Grade (N)
- AEACN_DECODE
Action Taken with Study Treatment
- DOSEDY
Day of Study Drug
- DOSEU
Treatment Dose Units
- DOSEON
Treatment Dose at Record Start
- AECONTRT
Concomitant or Additional Trtmnt Given
- CQ01NAM
Customized Query 01 Name
- CQ02NAM
Customized Query 02 Name
- CQ03NAM
Customized Query 03 Name
- AESMIE
Other Medically Important Serious Event
- ACAT1
Analysis Category 1
- AESER_DECODE
Serious Event
- AEREL_DECODE
Causality
- AEOUT_DECODE
Outcome of Adverse Event
- AOCCFL
1st Occurance within Subject Flag
- AOCCPFL
1st Occurance within Preferred Term Flag
- AOCCSFL
1st Occurrence of SOC Flag
- TRT01A
Actual Treatment for Period 01
- SAFFL
Safety Population Flag
- AGE
Age
- SEX
Sex
- RACE
Race
- RACE_DECODE
Race
- STUDYID
Study Identifier
- AGEGR1
Pooled Age Group 1
Source
data from pharmaverseadam.
See Also
adae adaefmq adcm adeg adex adexsum adlb adsl adttesaf advs# nolint
Examples
head(data("adae"))
adaefmq
Description
adae modified from pharmaverseadam to include FDA Medical Query information
Usage
adaefmq
Format
A data frame with 1979 rows and 81 variables:
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- AESEQ
Sequence Number
- AESPID
Sponsor-Defined Identifier
- AETERM
Reported Term for the Adverse Event
- AELLT
Lowest Level Term
- AELLTCD
Lowest Level Term Code
- AEDECOD
AEDECOD
- AEPTCD
Preferred Term Code
- AEHLT
High Level Term
- AEHLTCD
High Level Term Code
- AEHLGT
High Level Group Term
- AEHLGTCD
High Level Group Term Code
- AEBODSYS
Body System or Organ Class
- AEBDSYCD
Body System or Organ Class Code
- AESOC
Primary System Organ Class
- AESOCCD
Primary System Organ Class Code
- AESEV
Severity/Intensity
- AESER
Serious Event
- AEACN
Action Taken with Study Treatment
- AEREL
Causality
- AEOUT
Outcome of Adverse Event
- AESCAN
Involves Cancer
- AESCONG
Congenital Anomaly or Birth Defect
- AESDISAB
Persist or Signif Disability/Incapacity
- AESDTH
Results in Death
- AESHOSP
Requires or Prolongs Hospitalization
- AESLIFE
Is Life Threatening
- AESOD
Occurred with Overdose
- AEDTC
Date/Time of Collection
- AESTDTC
Start Date/Time of Adverse Event
- AEENDTC
End Date/Time of Adverse Event
- AESTDY
Study Day of Start of Adverse Event
- AEENDY
Study Day of End of Adverse Event
- ASTDTM
Analysis Start Date/Time
- ASTDTF
Analysis Start Date Imputation Flag
- ASTTMF
Analysis Start Time Imputation Flag
- AENDTM
Analysis End Date/Time
- AENDTF
Analysis End Date Imputation Flag
- AENTMF
Analysis End Time Imputation Flag
- ASTDT
Analysis Start Date
- AENDT
Analysis End Date
- ASTDY
Analysis Start Relative Day
- AENDY
Analysis End Relative Day
- ADURN
Analysis Duration (N)
- ADURU
Analysis Duration Units
- LDOSEDTM
End Date/Time of Last Dose
- ASEV
Analysis Severity/Intensity
- AREL
Analysis Causality
- TRTEMFL
Treatment Emergent Analysis Flag
- ASEVN
Analysis Severity/Intensity (N)
- AOCCIFL
1st Max Sev./Int. Occurrence Flag
- AETOXGR
Standard Toxicity Grade
- AETOXGRN
Standard Toxicity Grade (N)
- AEACN_DECODE
Action Taken with Study Treatment
- DOSEDY
Day of Study Drug
- DOSEU
Treatment Dose Units
- DOSEON
Treatment Dose at Record Start
- AECONTRT
Concomitant or Additional Trtmnt Given
- CQ01NAM
Customized Query 01 Name
- CQ02NAM
Customized Query 02 Name
- CQ03NAM
Customized Query 03 Name
- AESMIE
Other Medically Important Serious Event
- ACAT1
Analysis Category 1
- AESER_DECODE
Serious Event
- AEREL_DECODE
Causality
- AEOUT_DECODE
Outcome of Adverse Event
- AOCCFL
1st Occurance within Subject Flag
- AOCCPFL
1st Occurance within Preferred Term Flag
- AOCCSFL
1st Occurrence of SOC Flag
- TRT01A
Actual Treatment for Period 01
- SAFFL
Safety Population Flag
- AGE
Age
- SEX
Sex
- RACE
Race
- RACE_DECODE
Race
- STUDYID
Study Identifier
- AGEGR1
Pooled Age Group 1
- FMQNAM
FMQNAM
- FMQSOC
FMQSOC
- FMQCLASS
FMQCLASS
Source
data from adae from pharmaverseadam and, FDA_FMW_Consolidated_List.rds and FDA_FMQ_References.rds
See Also
adae adaefmq adcm adeg adex adexsum adlb adsl adttesaf advs# nolint
Examples
head(data("adaefmq"))
adcm
Description
adcm modified from pharmaverseadam
Usage
adcm
Format
A data frame with 7276 rows and 62 variables:
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- CMSEQ
Sequence Number
- CMSPID
Sponsor-Defined Identifier
- CMTRT
Reported Name of Drug, Med, or Therapy
- CMDECOD
Standardized Medication Name
- CMINDC
Indication
- CMCLAS
Medication Class
- CMDOSE
Dose per Administration
- CMDOSU
Dose Units
- CMDOSFRQ
Dosing Frequency per Interval
- CMROUTE
Route of Administration
- VISITNUM
Visit Number
- VISIT
Visit Name
- VISITDY
Planned Study Day of Visit
- CMDTC
Date/Time of Collection
- CMSTDTC
Start Date/Time of Medication
- CMENDTC
End Date/Time of Medication
- CMSTDY
Study Day of Start of Medication
- CMENDY
Study Day of End of Medication
- CMENRTPT
End Relative to Reference Time Point
- ASTDTM
Analysis Start Date/Time
- ASTDTF
Analysis Start Date Imputation Flag
- ASTTMF
Analysis Start Time Imputation Flag
- AENDTM
Analysis End Date/Time
- AENDTF
Analysis End Date Imputation Flag
- AENTMF
Analysis End Time Imputation Flag
- ASTDT
Analysis Start Date
- AENDT
Analysis End Date
- ASTDY
Analysis Start Relative Day
- AENDY
Analysis End Relative Day
- ADURN
Analysis Duration (N)
- ADURU
Analysis Duration Units
- ONTRTFL
On Treatment Record Flag
- PREFL
Pre-treatment Flag
- FUPFL
Follow-up Flag
- ANL01FL
Analysis Flag 01
- AOCCPFL
1st Occurrence of Preferred Term Flag
- APHASE
Phase
- APHASEN
Description of Phase N
- TRTP
Planned Treatment
- TRTA
Actual Treatment
- CMLVL1
Preferred ATC Text for ATC Level 1
- CMLVL2
Preferred ATC Text for ATC Level 2
- CMLVL3
Preferred ATC Text for ATC Level 3
- CMLVL4
Preferred ATC Text for ATC Level 4
- CMBASPRF
Base Preferred Term
- CMPRESP
CM Pre-specified
- CMOCCUR
CM Occurrence
- CMINDCSP
Indication Specification
- CMDOSTXT
Dose Description
- CMENRF
End Relative to Reference Period
- CQ01NAM
Customized Query 01 Name
- CQ02NAM
Customized Query 02 Name
- CQ03NAM
Customized Query 03 Name
- CQ04NAM
Customized Query 04 Name
- CQ05NAM
Customized Query 05 Name
- CQ06NAM
Customized Query 06 Name
- CQ07NAM
Customized Query 07 Name
- TRT01A
Actual Treatment for Period 01
- SAFFL
Safety Population Flag
- TRTSDT
Date of First Exposure to Treatment
Source
data from pharmaverseadam.
See Also
adae adaefmq adcm adeg adex adexsum adlb adsl adttesaf advs# nolint
Examples
head(data("adcm"))
adeg
Description
adeg modified from pharmaverseadam
Usage
adeg
Format
A data frame with 11844 rows and 70 variables:
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- EGSEQ
Sequence Number
- EGTESTCD
ECG Test or Examination Short Name
- EGTEST
ECG Test or Examination Name
- EGORRES
Result or Finding in Original Units
- EGORRESU
Original Units
- EGSTRESC
Character Result/Finding in Std Format
- EGSTRESN
Numeric Result/Finding in Standard Units
- EGSTRESU
Standard Units
- EGSTAT
Completion Status
- EGLOC
Lead Location Used for Measurement
- EGBLFL
Baseline Flag
- VISITNUM
Visit Number
- VISIT
Visit Name
- VISITDY
Planned Study Day of Visit
- EGDTC
Date/Time of ECG
- EGDY
Study Day of ECG
- EGTPT
Planned Time Point Name
- EGTPTNUM
Planned Time Point Number
- EGELTM
Planned Elapsed Time from Time Point Ref
- EGTPTREF
Time Point Reference
- ADTM
Analysis Datetime
- ATMF
Analysis Time Imputation Flag
- ADY
Analysis Relative Day
- PARAMCD
Parameter Code
- AVAL
Analysis Value
- AVALC
Analysis Value (C)
- ADT
Analysis Date
- ATPTN
Analysis Timepoint (N)
- ATPT
Analysis Timepoint
- AVISIT
Analysis Visit
- AVISITN
Analysis Visit (N)
- DTYPE
Derivation Type
- ONTRTFL
On Treatment Record Flag
- ANRLO
Analysis Normal Range Lower Limit
- ANRHI
Analysis Normal Range Upper Limit
- ANRIND
Analysis Reference Range Indicator
- BASETYPE
Baseline Type
- ABLFL
Baseline Record Flag
- BASEC
Baseline Value (C)
- CHG
Change from Baseline
- PCHG
Percent Change from Baseline
- ANL01FL
Analysis Flag 01-Analysis Value
- TRTP
Planned Treatment
- TRTA
Actual Treatment
- ASEQ
Analysis Sequence Number
- AVALCAT1
Analysis Value Category 1
- AVALCA1N
Analysis Value Category 1 (N)
- CHGCAT1
Change from Baseline Category 1
- CHGCAT1N
Change from Baseline Category 1 (N)
- PARAM
Parameter
- PARAMN
Parameter (N)
- TRTEMFL
Treatment Emergent Analysis Flag
- ANL02FL
Analysis Flag 02-By Visit Value
- ANL03FL
Analysis Flag 03-Maximum Value
- APOBLFL
Post-Baseline Record Flag
- CRIT1
Analysis Criterion 1
- CRIT1FL
Criterion 1 Evaluation Result Flag
- CRIT2
Analysis Criterion 2
- CRIT2FL
Criterion 2 Evaluation Result Flag
- BASE
Baseline Value
- BNRIND
Baseline Reference Range Indicator
- BASECAT1
Baseline Category 1
- TRT01A
Actual Treatment for Period 01
- SAFFL
Safety Population Flag
- STUDYID
Study Identifier
- AGE
Age
- SEX
Sex
- RACE_DECODE
Race
Source
data from pharmaverseadam.
See Also
adae adaefmq adcm adeg adex adexsum adlb adsl adttesaf advs# nolint
Examples
head(data("adeg"))
adex
Description
adex modified from pharmaverseadam
Usage
adex
Format
A data frame with 591 rows and 128 variables:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- EXSEQ
Sequence Number
- EXTRT
Planned Treatment
- EXDOSE
Adjusted Dose
- EXDOSU
Dose Units
- EXDOSFRM
Dose Form
- EXDOSFRQ
Dosing Frequency per Interval
- EXROUTE
Route of Administration
- VISITNUM
Visit Number
- VISIT
Visit Name
- VISITDY
Planned Study Day of Visit
- EXSTDTC
Start Date/Time of Treatment
- EXENDTC
End Date/Time of Treatment
- EXSTDY
Study Day of Start of Treatment
- EXENDY
Study Day of End of Treatment
- EXADJ
Reason for Dose Adjustment
- EXPLDOS
Planned Dose
- TRTSDT
Date of First Exposure to Treatment
- TRTSDTM
Datetime of First Exposure to Treatment
- TRTEDTM
Datetime of Last Exposure to Treatment
- ASTDTM
Analysis Start Datetime
- ASTDTF
Analysis Start Date Imputation Flag
- ASTTMF
Analysis Start Time Imputation Flag
- AENDTM
Analysis End Datetime
- AENDTF
Analysis End Date Imputation Flag
- AENTMF
Analysis End Time Imputation Flag
- ASTDY
Analysis Start Relative Day
- AENDY
Analysis End Relative Day
- EXDURD
Duration of Treatment (Days)
- ASTDT
Analysis Start Date
- AENDT
Analysis End Date
- DOSEO
Dose O
- PDOSEO
PDose O
- PARAMCD
Parameter Code
- AVAL
Analysis Value
- AVALC
Analysis Value (C)
- PARCAT1
Parameter Category 1
- PARAM
Parameter
- PARAMN
Parameter (N)
- AVALCAT1
Analysis Value Category 1
- ASEQ
Analysis Sequence Number
- SUBJID
Subject Identifier for the Study
- 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
- RFICDTC
Date/Time of Informed Consent
- RFPENDTC
Date/Time of End of Participation
- DTHDTC
Date/Time of Death
- DTHFL
Subject Death Flag
- SITEID
Study Site Identifier
- AGE
Age
- AGEU
Age Units
- SEX
Sex
- RACE
Race
- ETHNIC
Ethnicity
- ARMCD
Treatment Category Code
- ARM
Treatment Group
- ACTARMCD
Actual Arm Code
- ACTARM
Actual Treatment Group
- COUNTRY
Country
- DMDTC
Date/Time of Collection
- DMDY
Study Day of Collection
- TRT01P
Planned Treatment for Period 01
- TRT01A
Actual Treatment for Period 01
- TRTSTMF
Time of First Exposure Imput. Flag
- TRTETMF
Time of Last Exposure Imput. Flag
- TRTEDT
Date of Last Exposure to Treatment
- TRTDURD
Total Treatment Duration (Days)
- SCRFDT
Screen Failure Date
- EOSDT
End of Study Date
- EOSSTT
End of Study Status
- FRVDT
Final Retrievel Visit Date
- RANDDT
Date of Randomization
- DTHDT
Date of Death
- DTHDTF
DTHDTF
- DTHADY
Relative Day of Death
- LDDTHELD
Elapsed Days from Last Dose to Death
- DTHCAUS
DTHCAUS
- DTHDOM
DTHDOM
- DTHCGR1
DTHCGR1
- LSTALVDT
Date Last Known Alive
- SAFFL
Safety Population Flag
- RACEGR1
Pooled Race Group 1
- AGEGR1
Age Group
- REGION1
Geographic Region 1
- 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
- DTHB30FL
Death Within 30 Days of First Trt Flag
- ATRT
Analysis name of Treatment
- DAEXPDTC
Date of Exposure
- EXLOT
Lot Number
- ADOSE
Analysis Dose
- TRT01PN
Planned Treatment for Period 01 (N)
- AVISITN
Visit Number
- AVISIT
Visit Label
- TRT01AN
Actual Treatment for Period 01 (N)
- AOCCUR
Analysis Occurrence
- RACE_DECODE
Race
- ACAT1
Analysis Category 1
- AREASOC
Analysis Reason for Occur Value
- AREASOO
Other Analysis Reason for Occur Value
- AADJ
Analysis Reason for Dose Adjustment
- AADJPOTH
Other Anal Reason for Dose Adjust Prior
- AADJP
Analysis Reason for Dose Adjustment Prior
- AACTDU
Analysis Action Taken During Study Trt
- AACTDU1
Act Takn Dur Infus-Full Dose Admined
- AACTDU2
Act Takn Dur Infus-Infusion Aborted
- AACTDU3
Act Takn Dur Infus-Infusion Interrupted
- AACTDU4
Act Takn Dur Infus-Infusion Rate Decrsed
- AACTDU5
Act Takn Dur Infus-Infusion Rate Incrsed
- AADJOTH
Other Anal Reason for Dose Adjustment
- ACAT2
Analysis Category 2
- AACTPR
Action Taken Prior to Infudion Start
- AACTPR_DECODE
Action Taken Prior to Infusion Start
- ASCHDOSE
Analysis Scheduled Dose
- ASCHDOSU
Analysis Scheduled Dose Units
- ADOSFRM
Analysis Dose Form
- ADOSU
Analysis Dose Units
- ADOSFRQ
Analysis Dosing Frequency per Interval
- AROUTE
Analysis Route of Administration
- ATVINF
Analysis Total Volume Infused
- ATVINFU
Analysis Total Volume Infused Units
- AINFRAT
Analysis Infusion Rate
- AINFRAU
Analysis Infusion Rate Unit
Source
data from pharmaverseadam.
See Also
adae adaefmq adcm adeg adex adexsum adlb adsl adttesaf advs# nolint
Examples
head(data("adex"))
adexsum
Description
adex modified from pharmaverseadam
Usage
adexsum
Format
A data frame with 2794 rows and 25 variables:
- USUBJID
Unique Subject Identifier
- PARAMCD
Parameter Code
- PARAM
Parameter
- AVAL
Analysis Value
- AVALCAT1
Analysis Value Category 1
- AVALCA1N
Analysis Value Category 1 (N)
- CRIT1
Analysis Criterion 1
- CRIT1FL
Criterion 1 Evaluation Result Flag
- CRIT2
Analysis Criterion 2
- CRIT2FL
Criterion 2 Evaluation Result Flag
- CRIT3
Analysis Criterion 3
- CRIT3FL
Criterion 3 Evaluation Result Flag
- CRIT4
Analysis Criterion 4
- CRIT4FL
Criterion 4 Evaluation Result Flag
- CRIT5
Analysis Criterion 5
- CRIT5FL
Criterion 5 Evaluation Result Flag
- CRIT6
Analysis Criterion 6
- CRIT6FL
Criterion 6 Evaluation Result Flag
- CRIT7
Analysis Criterion 7
- CRIT7FL
Criterion 7 Evaluation Result Flag
- AVISIT
Analysis Visit
- AVISITN
Analysis Visit (N)
- TRT01A
Actual Treatment for Period 01
- SAFFL
Safety Population Flag
- STUDYID
Study Identifier
Source
data from adex from pharmaverseadam
See Also
adae adaefmq adcm adeg adex adexsum adlb adsl adttesaf advs# nolint
Examples
head(data("adexsum"))
adlb
Description
adlb modified from pharmaverseadam
Usage
adlb
Format
A data frame with 83640 rows and 152 variables:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- LBSEQ
Sequence Number
- LBTESTCD
Lab Test or Examination Short Name
- LBTEST
Lab Test or Examination Name
- LBCAT
Category for Lab Test
- LBORRES
Result or Finding in Original Units
- LBORRESU
Original Units
- LBORNRLO
Reference Range Lower Limit in Orig Unit
- LBORNRHI
Reference Range Upper Limit in Orig Unit
- LBSTRESC
Character Result/Finding in Std Format
- LBSTRESN
Numeric Result/Finding in Standard Units
- LBSTRESU
Standard Units
- LBSTNRLO
Reference Range Lower Limit-Std Units
- LBSTNRHI
Reference Range Upper Limit-Std Units
- LBNRIND
Reference Range Indicator
- LBBLFL
Baseline Flag
- VISITNUM
Visit Number
- VISIT
Visit Name
- VISITDY
Planned Study Day of Visit
- LBDTC
Date/Time of Specimen Collection
- LBDY
Study Day of Specimen Collection
- TRTSDT
Date of First Exposure to Treatment
- TRTEDT
Date of Last Exposure to Treatment
- TRT01A
Actual Treatment for Period 01
- TRT01P
Planned Treatment for Period 01
- ADT
Analysis Date
- ADY
Analysis Relative Day
- PARAMCD
Parameter Code
- PARAM
Parameter
- PARAMN
Parameter (N)
- PARCAT1
Parameter Category 1
- AVAL
Analysis Value
- AVALC
Analysis Value (C)
- ANRLO
Analysis Normal Range Lower Limit
- ANRHI
Analysis Normal Range Upper Limit
- DTYPE
Derivation Type
- AVISIT
Analysis Visit
- AVISITN
Analysis Visit (N)
- ONTRTFL
On Treatment Record Flag
- ANRIND
Analysis Reference Range Indicator
- BASETYPE
Baseline Type
- ABLFL
Baseline Record Flag
- BASE
Baseline Value
- BASEC
Baseline Value (C)
- BNRIND
Baseline Reference Range Indicator
- CHG
Change from Baseline
- PCHG
Percent Change from Baseline
- ATOXDSCL
Analysis Toxicity Description Low
- ATOXDSCH
Analysis Toxicity Description High
- ATOXGRL
Analysis Toxicity Grade Low
- ATOXGRH
Analysis Toxicity Grade High
- ATOXGR
Analysis Toxicity Grade
- BTOXGRL
Baseline Toxicity Grade Low
- BTOXGRH
Baseline Toxicity Grade High
- BTOXGR
Baseline Toxicity Grade
- R2BASE
Ratio to Baseline
- R2ANRLO
Ratio of Analysis Val compared to ANRLO
- R2ANRHI
Ratio of Analysis Val compared to ANRHI
- SHIFT1
Shift from Baseline to Analysis Value
- SHIFT2
Shift from Baseline to Overall Grade
- ANL01FL
Analysis Flag 01
- LVOTFL
Last Value On Treatment Record Flag
- TRTP
Planned Treatment
- TRTA
Actual Treatment
- ASEQ
Analysis Sequence Number
- SUBJID
Subject Identifier for the Study
- 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
- RFICDTC
Date/Time of Informed Consent
- RFPENDTC
Date/Time of End of Participation
- DTHDTC
Date/Time of Death
- DTHFL
Subject Death Flag
- SITEID
Study Site Identifier
- AGE
Age
- AGEU
Age Units
- SEX
Sex
- RACE
Race
- ETHNIC
Ethnicity
- ARMCD
Planned Arm Code
- ARM
Description of Planned Arm
- ACTARMCD
Actual Arm Code
- ACTARM
Description of Actual Arm
- COUNTRY
Country
- DMDTC
Date/Time of Collection
- DMDY
Study Day of Collection
- TRTSDTM
Datetime of First Exposure to Treatment
- TRTSTMF
Time of First Exposure Imput. Flag
- TRTEDTM
Datetime of Last Exposure to Treatment
- TRTETMF
Time of Last Exposure Imput. Flag
- TRTDURD
Total Treatment Duration (Days)
- SCRFDT
Screen Failure Date
- EOSDT
End of Study Date
- EOSSTT
End of Study Status
- FRVDT
Final Retrievel Visit Date
- RANDDT
Date of Randomization
- DTHDT
Date of Death
- DTHDTF
DTHDTF
- DTHADY
Relative Day of Death
- LDDTHELD
Elapsed Days from Last Dose to Death
- DTHCAUS
DTHCAUS
- DTHDOM
DTHDOM
- DTHCGR1
DTHCGR1
- LSTALVDT
Date Last Known Alive
- SAFFL
Safety Population Flag
- RACEGR1
Pooled Race Group 1
- REGION1
Geographic Region 1
- 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
- DTHB30FL
Death Within 30 Days of First Trt Flag
- TRT01PN
Planned Treatment for Period 01 (N)
- TRT01AN
Actual Treatment for Period 01 (N)
- AVALU
Analysis Value - Units
- ANL02FL
Analysis Record Flag 02-Analysis Value
- TRTEMFL
Treatment Emergent Analysis Flag
- COUNTRY_DECODE
Country
- RACE_DECODE
Race Description
- ETHNIC_DECODE
Ethnicity Description
- PARCAT2
Parameter Category 2
- PARCAT3
Parameter Category 3
- PARCAT4
Parameter Category 4
- PARCAT5
Parameter Category 5
- PARCAT6
Parameter Category 6
- MCRIT2ML
Multi-Response Criterion 2 Evaluation
- MCRIT1ML
Multi-Response Criterion 1 Evaluation
- MCRIT1MN
Multi-Response Criterion 1 Eval (N)
- MCRIT2MN
Multi-Response Criterion 2 Eval (N)
- MCRIT1
Analysis Multi-Response Criterion 1
- MCRIT2
Analysis Multi-Response Criterion 2
- APOBLFL
Post-Baseline Record Flag
- LBSTNRHQ
Reference Limit Higher
- LBSTNRLQ
Reference Limit Lower
- ATOXGRN
Analysis Toxicity Grade (Numeric)
- ADTM
Analysis Date/Time
- ATPT
Analysis Timepoint
- TR01SDT
Start Date of Treatment for Period 01
- TR01EDT
End Date of Treatment for Period 01
- ANL03FL
Analysis Record Flag 03 - Protocol Visit
- ANL04FL
Analysis Flag 04
- ANL05FL
Analysis Flag 05
- ANL06FL
Analysis Flag 06
- ANL07FL
Analysis Flag 07
- ANL08FL
Analysis Flag 08
- ANL09FL
Analysis Flag 09
- ANL10FL
Analysis Flag 10
- ANL14FL
Analysis Flag 14
- ANL15FL
Analysis Flag 15
- ANL16FL
Analysis Flag 16
Source
data from pharmaverseadam.
See Also
adae adaefmq adcm adeg adex adexsum adlb adsl adttesaf advs# nolint
Examples
head(data("adlb"))
adsl
Description
adsl modified from pharmaverseadam
Usage
adsl
Format
A data frame with 306 rows and 106 variables:
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- SUBJID
Subject Identifier for the Study
- 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
- RFICDTC
Date/Time of Informed Consent
- RFPENDTC
Date/Time of End of Participation
- DTHDTC
Date/Time of Death
- DTHFL
Subject Death Flag
- SITEID
Study Site Identifier
- AGE
Age
- AGEU
Age Units
- SEX
Sex
- RACE
Race
- ETHNIC
Ethnicity
- ARMCD
Planned Arm Code
- ARM
Description of Planned Arm
- ACTARMCD
Actual Arm Code
- ACTARM
Description of Actual Arm
- COUNTRY
Country
- DMDTC
Date/Time of Collection
- DMDY
Study Day of Collection
- TRT01P
Planned Treatment for Period 01
- TRT01A
Actual Treatment for Period 01
- TRTSDTM
Datetime of First Exposure to Treatment
- TRTSTMF
Time of First Exposure Imput. Flag
- TRTEDTM
Datetime of Last Exposure to Treatment
- TRTETMF
Time of Last Exposure Imput. Flag
- TRTSDT
Date of First Exposure to Treatment
- TRTEDT
Date of Last Exposure to Treatment
- TRTDURD
Total Treatment Duration (Days)
- SCRFDT
Screen Failure Date
- EOSDT
End of Study Date
- EOSSTT
End of Study Status
- FRVDT
Final Retrievel Visit Date
- RANDDT
Date of Randomization
- DTHDT
Date of Death
- DTHDTF
Date of Death Imputation Flag
- DTHADY
Relative Day of Death
- LDDTHELD
Elapsed Days from Last Dose to Death
- DTHCAUS
DTHCAUS
- DTHDOM
DTHDOM
- DTHCGR1
DTHCGR1
- LSTALVDT
Date Last Known Alive
- SAFFL
Safety Population Flag
- RACEGR1
Pooled Race Group 1
- AGEGR1
Pooled Age Group 1
- REGION1
Geographic Region 1
- 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
- DTHB30FL
Death Within 30 Days of First Trt Flag
- TRT01PN
Planned Treatment for Period 01 (N)
- TRT01AN
Actual Treatment for Period 01 (N)
- AGEGR1N
Pooled Age Group 1 (N)
- SEX_DECODE
Sex
- WEIGHTBL
Weight (kg)
- WGTGR1N
Weight Group 1 (N)
- WGTGR1
Weight Group 1
- HEIGHTBL
Height (cm)
- BSABL
Body surface area (m2)
- BMIBL
Body mass index (kg/m2)
- BMIBLG1N
BMI at Baseline Group 1 (N)
- BMIBLG1
BMI at Baseline Group 1
- COUNTRY_DECODE
Country
- RACE_DECODE
Race
- RFICDT
Date of Informed Consent
- ETHNIC_DECODE
Ethnicity
- STRAT1R
Strat Factor 1 Value Used for Rand
- STRAT2R
Strat Factor 2 Value Used for Rand
- RANUM
Randomization Number
- RANDDTM
Datetime of Randomization
- EOTSTT
End of Treatment Status
- DCTREAS
Reason for Discontinuation of Treatment
- LTVISIT
Last Treatment Visit
- DCTREASP
Reason Specify for Discont of Treatment
- DCTDT
End of Study Date
- DCSREAS
Reason for Discontinuation from Study
- DCSREASP
Reason Spec for Discont from Study
- LSVISIT
Last Study Visit
- TRTEDY
Treatment Relative End Day
- SCRNFL
Screened Population Flag
- SCRFFL
Screen Failure Flag
- DCSCREEN
Reason for Discont During Screening
- ENRLFL
Enrolled Population Flag
- RANDFL
Randomized Flag
- ITTFL
Intent-To-Treat Population Flag
- FASFL
Full Analysis Set Population Flag
- PPROTFL
Per-Protocol Population Flag
- LSTSVDT
Last Subject Visit (SV) Date
- EOSDY
Study Day of Study Termination
- UNBLNDFL
Subject Blind Broken
- RESCRNFL
Re-screened Flag
- DTHTRTFL
Death on Treatment Flag
- DTHCAUSP
Cause Spec for Death
- DTHAFTFL
Death After 30 Days of Last Treatment
- DTH60TFL
Death Within 60 Days of First Treatment
- UNBLNDDY
Study Day of Unblinding
- UNBREAS
Reason For Unblinding
- LDOSE
Last Dose
- LDOSU
Last Dose Unit
- DTHTERM
Reported Cause of Death
- LDSTODTH
Days from Last Dose to Death
- DTHDY
Study Day of Death
Source
data from pharmaverseadam.
See Also
adae adaefmq adcm adeg adex adexsum adlb adsl adttesaf advs# nolint
Examples
head(data("adsl"))
adttesaf
Description
adtte_onc modified from pharmaverseadam
Usage
adttesaf
Format
A data frame with 2032 rows and 9 variables:
- USUBJID
Unique Subject Identifier
- PARAMCD
Parameter Code
- PARAM
Parameter
- AVAL
Analysis Value
- CNSR
Censor
- STARTDT
Start Date
- ADT
Analysis Date
- TRT01A
Actual Treatment for Period 01
- SAFFL
Safety Population Flag
Source
data from adtte_onc from pharmaverseadam
See Also
adae adaefmq adcm adeg adex adexsum adlb adsl adttesaf advs# nolint
Examples
head(data("adttesaf"))
advs
Description
advs modified from pharmaverseadam
Usage
advs
Format
A data frame with 40702 rows and 78 variables:
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- VSSEQ
Sequence Number
- VSTESTCD
Vital Signs Test Short Name
- VSTEST
Vital Signs Test Name
- VSPOS
Vital Signs Position of Subject
- VSORRES
Result or Finding in Original Units
- VSORRESU
Original Units
- VSSTRESC
Character Result/Finding in Std Format
- VSSTRESN
Numeric Result/Finding in Standard Units
- VSSTRESU
Standard Units
- VSSTAT
Completion Status
- VSLOC
Location of Vital Signs Measurement
- VSBLFL
Baseline Flag
- VISITNUM
Visit Number
- VISIT
Visit Name
- VISITDY
Planned Study Day of Visit
- VSDTC
Date/Time of Measurements
- VSDY
Study Day of Vital Signs
- VSTPT
Planned Time Point Name
- VSTPTNUM
Planned Time Point Number
- VSELTM
Planned Elapsed Time from Time Point Ref
- VSTPTREF
Time Point Reference
- ADT
Analysis Date
- ADY
Analysis Relative Day
- PARAMCD
Parameter Code
- AVAL
Analysis Value
- ATPTN
Analysis Timepoint (N)
- ATPT
Analysis Time Point
- AVISIT
Analysis Visit
- AVISITN
Analysis Visit (N)
- DTYPE
Derivation Type
- ONTRTFL
On Treatment Record Flag
- ANRLO
Analysis Normal Range Lower Limit
- ANRHI
Analysis Normal Range Upper Limit
- A1LO
Analysis Range 1 Lower Limit
- A1HI
Analysis Range 1 Upper Limit
- ANRIND
Analysis Reference Range Indicator
- BASETYPE
Baseline Type
- ABLFL
Baseline Record Flag
- CHG
Change from Baseline
- PCHG
Percent Change from Baseline
- ANL01FL
Analysis Flag 01
- TRTP
Planned Treatment
- TRTA
Actual Treatment
- ASEQ
Analysis Sequence Number
- AVALCAT1
Analysis Value Category 1
- AVALCA1N
Analysis Value Category 1 (N)
- PARAM
Parameter
- PARAMN
Parameter (N)
- AVALC
Analysis Value (C)
- ANL02FL
Analysis Flag 02-By Visit Value
- APOBLFL
Post-Baseline Record Flag
- BASE
Baseline Value
- BNRIND
Baseline Reference Range Indicator
- ADTM
Analysis Date/Time
- CRIT1
Analysis Criterion 1
- CRIT1FL
Criterion 1 Evaluation Result Flag
- CRIT2
Analysis Criterion 2
- CRIT2FL
Criterion 2 Evaluation Result Flag
- CRIT3
Analysis Criterion 3
- CRIT3FL
Criterion 3 Evaluation Result Flag
- ATOXDSCL
Analysis Toxicity Description Low
- ATOXDSCH
Analysis Toxicity Description High
- ATOXGRL
Analysis Toxicity Grade Low
- ATOXGRH
Analysis Toxicity Grade High
- ATOXGR
Analysis Toxicity Grade
- ANL06FL
Analysis Flag 06-Minimum Value
- ANL05FL
Analysis Flag 05-Worst Tox Grade High
- ANL04FL
Analysis Flag 04-Worst Value
- ANL03FL
Analysis Flag 03-Maximum Value
- TRTEMFL
Treatment Emergent Analysis Flag
- TRT01A
Actual Treatment for Period 01
- SAFFL
Safety Population Flag
- STUDYID
Study Identifier
- AGE
Age
- SEX
Sex
- RACE_DECODE
Race
Source
data from pharmaverseadam.
See Also
adae adaefmq adcm adeg adex adexsum adlb adsl adttesaf advs# nolint
Examples
head(data("advs"))