| Title: | J&J Innovative Medicine ADaM Test Data |
| Version: | 0.0.4 |
| 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 |
| LazyDataCompression: | xz |
| RoxygenNote: | 7.3.3 |
| Language: | en-US |
| Depends: | R (≥ 3.5), pharmaverseadam (≥ 1.3.0) |
| NeedsCompilation: | no |
| Packaged: | 2026-05-07 14:48:06 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: | 2026-05-07 16:41:13 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 83 variables:
- USUBJID
Unique Subject Identifier
- DOMAIN
Domain Abbreviation
- AESEQ
Sequence Number
- AETERM
Reported Term for the Adverse Event
- AEDECOD
Dictionary-Derived Term
- AEBODSYS
Body System or Organ Class
- AEBDSYCD
Body System or Organ Class Code
- AELLT
Lowest Level Term
- AELLTCD
Lowest Level Term Code
- AEPTCD
Preferred Term Code
- AEHLT
High Level Term
- AEHLTCD
High Level Term Code
- AEHLGT
High Level Group Term
- AEHLGTCD
High Level Group Term Code
- AESOC
Primary System Organ Class
- AESOCCD
Primary System Organ Class Code
- AESTDTC
Start Date/Time of Adverse Event
- ASTDT
Analysis Start Date
- ASTDTM
Analysis Start Date/Time
- ASTDTF
Analysis Start Date Imputation Flag
- ASTTMF
Analysis Start Time Imputation Flag
- AEENDTC
End Date/Time of Adverse Event
- AENDT
Analysis End Date
- AENDTM
Analysis End Date/Time
- AENDTF
Analysis End Date Imputation Flag
- AENTMF
Analysis End Time Imputation Flag
- ASTDY
Analysis Start Relative Day
- AESTDY
Study Day of Start of Adverse Event
- AENDY
Analysis End Relative Day
- AEENDY
Study Day of End of Adverse Event
- ADURN
Analysis Duration (N)
- ADURU
Analysis Duration Units
- TRTEMFL
Treatment Emergent Analysis Flag
- AOCCIFL
1st Max Sev./Int. Occurrence Flag
- AESER
Serious Event
- AESDTH
Results in Death
- AESLIFE
Is Life Threatening
- AESHOSP
Requires or Prolongs Hospitalization
- AESDISAB
Persist or Signif Disability/Incapacity
- AESCONG
Congenital Anomaly or Birth Defect
- AESEV
Severity/Intensity
- ASEV
Analysis Severity/Intensity
- ASEVN
Analysis Severity/Intensity (N)
- AEREL
Causality
- AREL
Analysis Causality
- AEACN
Action Taken with Study Treatment
- AESPID
Sponsor-Defined Identifier
- AEOUT
Outcome of Adverse Event
- AESCAN
Involves Cancer
- AESOD
Occurred with Overdose
- AEDTC
Date/Time of Collection
- LDOSEDTM
End Date/Time of Last Dose
- DOSEON
Treatment Dose at Record Start
- DOSEU
Treatment Dose Units
- AETOXGR
Standard Toxicity Grade
- AETOXGRN
Standard Toxicity Grade (N)
- DOSEDY
Day of Study Drug
- 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
- AOCCFL
1st Occurrence within Subject Flag
- AOCCPFL
1st Occurrence within Pref Term Flag
- AOCCSFL
1st Occurrence of SOC Flag
- AOCTIFL
1st TE Max Toxicity Grade Flag
- TRT01A
Actual Treatment for Period 01
- SAFFL
Safety Population Flag
- AGE
Age
- SEX
Sex
- RACE
Race
- STUDYID
Study Identifier
- AGEGR1
Pooled Age Group 1
- TRTEDY
Treatment Relative End Day
- TRT01P
Planned Treatment for Period 01
- TRDISCFL
Treatment Discontinued Flag
- AESHOSPP
Prolongs Hospitalization
- AESHOSPR
Requires Hospitalization
- AESCAT
AESCAT
- SMQ01NAM
Standardized MedDRA Query 01 Name
- SMQ02NAM
Standardized MedDRA Query 02 Name
- SMQ03NAM
Standardized MedDRA Query 03 Name
Source
data from pharmaverseadam.
See Also
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
Examples
head(data("adae"))
adaeocmq
Description
adae modified from pharmaverseadam to include Office of New Drugs (OND) Custom Medical Queries
Usage
adaeocmq
Format
A data frame with 1972 rows and 88 variables:
- USUBJID
Unique Subject Identifier
- DOMAIN
Domain Abbreviation
- AESEQ
Sequence Number
- AETERM
Reported Term for the Adverse Event
- AEDECOD
AEDECOD
- AEBODSYS
Body System or Organ Class
- AEBDSYCD
Body System or Organ Class Code
- AELLT
Lowest Level Term
- AELLTCD
Lowest Level Term Code
- AEPTCD
Preferred Term Code
- AEHLT
High Level Term
- AEHLTCD
High Level Term Code
- AEHLGT
High Level Group Term
- AEHLGTCD
High Level Group Term Code
- AESOC
Primary System Organ Class
- AESOCCD
Primary System Organ Class Code
- AESTDTC
Start Date/Time of Adverse Event
- ASTDT
Analysis Start Date
- ASTDTM
Analysis Start Date/Time
- ASTDTF
Analysis Start Date Imputation Flag
- ASTTMF
Analysis Start Time Imputation Flag
- AEENDTC
End Date/Time of Adverse Event
- AENDT
Analysis End Date
- AENDTM
Analysis End Date/Time
- AENDTF
Analysis End Date Imputation Flag
- AENTMF
Analysis End Time Imputation Flag
- ASTDY
Analysis Start Relative Day
- AESTDY
Study Day of Start of Adverse Event
- AENDY
Analysis End Relative Day
- AEENDY
Study Day of End of Adverse Event
- ADURN
Analysis Duration (N)
- ADURU
Analysis Duration Units
- TRTEMFL
Treatment Emergent Analysis Flag
- AOCCIFL
1st Max Sev./Int. Occurrence Flag
- AESER
Serious Event
- AESDTH
Results in Death
- AESLIFE
Is Life Threatening
- AESHOSP
Requires or Prolongs Hospitalization
- AESDISAB
Persist or Signif Disability/Incapacity
- AESCONG
Congenital Anomaly or Birth Defect
- AESEV
Severity/Intensity
- ASEV
Analysis Severity/Intensity
- ASEVN
Analysis Severity/Intensity (N)
- AEREL
Causality
- AREL
Analysis Causality
- AEACN
Action Taken with Study Treatment
- AESPID
Sponsor-Defined Identifier
- AEOUT
Outcome of Adverse Event
- AESCAN
Involves Cancer
- AESOD
Occurred with Overdose
- AEDTC
Date/Time of Collection
- LDOSEDTM
End Date/Time of Last Dose
- DOSEON
Treatment Dose at Record Start
- DOSEU
Treatment Dose Units
- AETOXGR
Standard Toxicity Grade
- AETOXGRN
Standard Toxicity Grade (N)
- DOSEDY
Day of Study Drug
- 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
- AOCCFL
1st Occurrence within Subject Flag
- AOCCPFL
1st Occurrence within Pref Term Flag
- AOCCSFL
1st Occurrence of SOC Flag
- AOCTIFL
1st TE Max Toxicity Grade Flag
- TRT01A
Actual Treatment for Period 01
- SAFFL
Safety Population Flag
- AGE
Age
- SEX
Sex
- RACE
Race
- STUDYID
Study Identifier
- AGEGR1
Pooled Age Group 1
- TRTEDY
Treatment Relative End Day
- TRT01P
Planned Treatment for Period 01
- TRDISCFL
Treatment Discontinued Flag
- AESHOSPP
Prolongs Hospitalization
- AESHOSPR
Requires Hospitalization
- AESCAT
AESCAT
- SMQ01NAM
Standardized MedDRA Query 01 Name
- SMQ02NAM
Standardized MedDRA Query 02 Name
- SMQ03NAM
Standardized MedDRA Query 03 Name
- OCMQNAM
Custom Medical Query Name
- OCMQSOC
Custom Medical Query System Organ Class
- OCMQCLSS
Custom Medical Query Scope
- GENSPMFL
Gender Specific OCMQ Male Flag
- GENSPFFL
Gender Specific OCMQ Female Flag
Source
data from adae from pharmaverseadam and, FDA_OCMQ_Consolidated_List.rds and FDA_OCMQ_References.rds
See Also
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
Examples
head(data("adaeocmq"))
adagocmq
Description
adagocmq modified from pharmaverseadam
Usage
adagocmq
Format
A data frame with 1301 rows and 27 variables:
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- ASTDT
Analysis Start Date
- ASTDY
Analysis Start Relative Day
- TRT01P
Planned Treatment for Period 01
- TRT01PN
Planned Treatment for Period 01 (N)
- TRT01A
Actual Treatment for Period 01
- TRT01AN
Actual Treatment for Period 01 (N)
- ACAT1
Analysis Category 1
- ACAT1N
Analysis Category 1 (N)
- ATERM
Analysis Term (N)
- ATERMN
Analysis Term
- HYPSCAT
Hypersensitivity Category
- SRCVALUE
Source Value
- SRCVAR
Source Variable
- SRCDOM
Source Data
- SRCSEQ
Source Sequence Number
- ANL01FL
Analysis Flag 01
- AGE
Age
- AGEU
Age Units
- SEX
Sex
- RACE
Race
- COUNTRY
Country
- RANDFL
Randomized Flag
- SAFFL
Safety Population Flag
- SITEID
Study Site Identifier
- SUBJID
Subject Identifier for the Study
Source
data from pharmaverseadam.
See Also
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
Examples
head(data("adagocmq"))
adcm
Description
adcm modified from pharmaverseadam
Usage
adcm
Format
A data frame with 7276 rows and 63 variables:
- USUBJID
Unique Subject Identifier
- DOMAIN
Domain Abbreviation
- TRTP
Planned Treatment
- TRTA
Actual Treatment
- APHASE
Phase
- APHASEN
Description of Phase N
- CMSEQ
Sequence Number
- CMDECOD
Standardized Medication Name
- CMTRT
Reported Name of Drug, Med, or Therapy
- CMCLAS
Medication Class
- CMSTDTC
Start Date/Time of Medication
- ASTDT
Analysis Start Date
- ASTDTM
Analysis Start Date/Time
- ASTDTF
Analysis Start Date Imputation Flag
- ASTTMF
Analysis Start Time Imputation Flag
- CMENDTC
End Date/Time of Medication
- AENDT
Analysis End Date
- AENDTM
Analysis End Date/Time
- AENDTF
Analysis End Date Imputation Flag
- AENTMF
Analysis End Time Imputation Flag
- ASTDY
Analysis Start Relative Day
- CMSTDY
Study Day of Start of Medication
- AENDY
Analysis End Relative Day
- CMENDY
Study Day of End of Medication
- ADURN
Analysis Duration (N)
- ADURU
Analysis Duration Units
- ANL01FL
Analysis Flag 01
- ONTRTFL
On Treatment Record Flag
- PREFL
Pre-treatment Flag
- FUPFL
Follow-up Flag
- AOCCPFL
1st Occurrence of Preferred Term Flag
- CMINDC
Indication
- CMDOSE
Dose per Administration
- CMDOSU
Dose Units
- CMDOSFRQ
Dosing Frequency per Interval
- CMROUTE
Route of Administration
- CMSPID
Sponsor-Defined Identifier
- CMENRTPT
End Relative to Reference Time Point
- VISITNUM
Visit Number
- VISIT
Visit Name
- VISITDY
Planned Study Day of Visit
- CMDTC
Date/Time of Collection
- 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
- STUDYID
Study Identifier
Source
data from pharmaverseadam.
See Also
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
Examples
head(data("adcm"))
addili
Description
addili modified from pharmaverseadam
Usage
addili
Format
A data frame with 10476 rows and 71 variables:
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- PARAMCD
Parameter Code
- PARAM
Parameter
- ADT
Analysis Date
- ADTM
Analysis Date/Time
- ADY
Analysis Relative Day
- AVISIT
Analysis Visit
- AVISITN
Analysis Visit (N)
- ATPT
Analysis Timepoint
- TRTP
Planned Treatment
- TRTA
Actual Treatment
- AVAL
Analysis Value
- BASE
Baseline Value
- ANRIND
Analysis Reference Range Indicator
- BNRIND
Baseline Reference Range Indicator
- ANRLO
Analysis Normal Range Lower Limit
- ANRHI
Analysis Normal Range Upper Limit
- ABLFL
Baseline Record Flag
- APOBLFL
Post-Baseline Record Flag
- ONTRTFL
On Treatment Record Flag
- LBSEQ
Sequence Number
- VISIT
Visit Name
- VISITNUM
Visit Number
- LBNAM
Laboratory Name
- DTYPE
Derivation Type
- TRT01P
Planned Treatment for Period 01
- TRT01PN
Planned Treatment for Period 01 (N)
- TRT01A
Actual Treatment for Period 01
- TRT01AN
Actual Treatment for Period 01 (N)
- TRTSDT
Date of First Exposure to Treatment
- TRTSDTM
Datetime of First Exposure to Treatment
- TRTEDT
Date of Last Exposure to Treatment
- TRTEDTM
Datetime of Last Exposure to Treatment
- AGE
Age
- AGEU
Age Units
- AGEGR1
Pooled Age Group 1
- AGEGR1N
Pooled Age Group 1 (N)
- SEX
Sex
- RACE
Race
- COUNTRY
Country
- SAFFL
Safety Population Flag
- FASFL
Full Analysis Set Population Flag
- RANDFL
Randomized Population Flag
- DTHFL
Subject Death Flag
- SITEID
Study Site Identifier
- SUBJID
Subject Identifier for the Study
- PARCAT1
Parameter Category 1
- R2ANRHI
Ratio to ANR Upper Limit
- 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
- ANL04FL
Analysis 04 Record Flag
- ANL06FL
Analysis 06 Record Flag
- ANL05FL
Analysis 05 Record Flag
- ANL07FL
Analysis 07 Record Flag
- ANL02FL
Analysis 02 Record Flag
- ANL03FL
Analysis 03 Record Flag
- AVALC
Analysis Value (C)
- AVALCAT1
Analysis Value Category 1
- AVALCA1N
Analysis Value Category 1 (N)
- AVALCAT2
Analysis Value Category 2
- AVALCA2N
Analysis Value Category 2 (N)
- ASEQ
Analysis Sequence Number
Source
data from pharmaverseadam.
See Also
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
Examples
head(data("addili"))
adeg
Description
adeg modified from pharmaverseadam
Usage
adeg
Format
A data frame with 13536 rows and 70 variables:
- USUBJID
Unique Subject Identifier
- DOMAIN
Domain Abbreviation
- ASEQ
Analysis Sequence Number
- TRTP
Planned Treatment
- TRTA
Actual Treatment
- ADT
Analysis Date
- ADTM
Analysis Datetime
- ADY
Analysis Relative Day
- ATMF
Analysis Time Imputation Flag
- AVISIT
Analysis Visit
- AVISITN
Analysis Visit (N)
- ATPT
Analysis Timepoint
- ATPTN
Analysis Timepoint (N)
- PARAM
Parameter
- PARAMCD
Parameter Code
- PARAMN
Parameter (N)
- AVAL
Analysis Value
- AVALC
Analysis Value (C)
- AVALCAT1
Analysis Value Category 1
- AVALCA1N
Analysis Value Category 1 (N)
- BASEC
Baseline Value (C)
- BASETYPE
Baseline Type
- CHG
Change from Baseline
- CHGCAT1
Change from Baseline Category 1
- CHGCAT1N
Change from Baseline Category 1 (N)
- PCHG
Percent Change from Baseline
- DTYPE
Derivation Type
- ANRIND
Analysis Reference Range Indicator
- ANRLO
Analysis Normal Range Lower Limit
- ANRHI
Analysis Normal Range Upper Limit
- ABLFL
Baseline Record Flag
- ANL01FL
Analysis Flag 01-Analysis Value
- ONTRTFL
On Treatment Record Flag
- 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
- 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
- EGCLSIG
Clinically Significant
- 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
Source
data from pharmaverseadam.
See Also
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
Examples
head(data("adeg"))
adex
Description
adex modified from pharmaverseadam
Usage
adex
Format
A data frame with 591 rows and 130 variables:
- 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
Age Group
- SEX
Sex
- RACE
Race
- RACEGR1
Pooled Race Group 1
- ETHNIC
Ethnicity
- SAFFL
Safety Population Flag
- ARM
Treatment Group
- ARMCD
Treatment Category Code
- ACTARM
Actual Treatment Group
- 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
- DTHDTF
Date of Death Imputation Flag
- DTHCAUS
Cause of Death
- DTHCGR1
Cause of Death Reason 1
- EXTRT
Planned Treatment
- EXDOSE
Adjusted Dose
- EXDOSFRM
Dose Form
- EXDOSFRQ
Dosing Frequency per Interval
- EXROUTE
Route of Administration
- EXADJ
Reason for Dose Adjustment
- 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
- EXSEQ
Sequence Number
- ASTDT
Analysis Start Date
- AENDT
Analysis End Date
- EXDURD
Duration of Treatment (Days)
- EXDOSU
Dose Units
- VISITNUM
Visit Number
- VISIT
Visit Name
- VISITDY
Planned Study Day of Visit
- EXPLDOS
Planned Dose
- 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
- 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
- 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
- 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 Prior Dose Adjust
- 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 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
- ABODSYS1
AE SOC Driving Study Drug Action (1)
- ABODSYS2
AE SOC Driving Study Drug Action (2)
- ADECOD1
AE PT Driving Study Drug Action (1)
- ADECOD2
AE PT Driving Study Drug Action (2)
Source
data from pharmaverseadam.
See Also
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc 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 adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
Examples
head(data("adexsum"))
adlb
Description
adlb modified from pharmaverseadam
Usage
adlb
Format
A data frame with 83640 rows and 153 variables:
- 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
- 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
- TRTP
Planned Treatment
- TRTA
Actual Treatment
- 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
- DTHDTF
Date of Death Imputation Flag
- DTHCAUS
Cause of Death
- DTHCGR1
Cause of Death Reason 1
- ADT
Analysis Date
- ADY
Analysis Relative Day
- AVISIT
Analysis Visit
- AVISITN
Analysis Visit (N)
- PARAM
Parameter
- PARAMCD
Parameter Code
- PARAMN
Parameter (N)
- PARCAT1
Parameter Category 1
- AVAL
Analysis Value
- AVALC
Analysis Value (C)
- BASE
Baseline Value
- BASEC
Baseline Value (C)
- BASETYPE
Baseline Type
- CHG
Change from Baseline
- PCHG
Percent Change from Baseline
- 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
- DTYPE
Derivation Type
- ATOXGR
Analysis Toxicity Grade
- BTOXGR
Baseline Toxicity Grade
- ANRIND
Analysis Reference Range Indicator
- BNRIND
Baseline Reference Range Indicator
- ANRLO
Analysis Normal Range Lower Limit
- ANRHI
Analysis Normal Range Upper Limit
- ATOXGRL
Analysis Toxicity Grade Low
- ATOXGRH
Analysis Toxicity Grade High
- BTOXGRL
Baseline Toxicity Grade Low
- BTOXGRH
Baseline Toxicity Grade High
- ATOXDSCL
Analysis Toxicity Description Low
- ATOXDSCH
Analysis Toxicity Description High
- ABLFL
Baseline Record Flag
- ANL01FL
Analysis Flag 01
- ONTRTFL
On Treatment Record Flag
- LVOTFL
Last Value On Treatment Record Flag
- 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
- 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
- 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
- LBCLSIG
Clinically Significant
- TR01SDT
Start Date of Treatment for Period 01
- TR01EDT
End Date of Treatment for Period 01
- LBSPEC
Specimen Type
- LBFAST
Fasting Status
- LBNAM
Laboratory Name
- 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 adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
Examples
head(data("adlb"))
adpc
Description
adpc modified from pharmaverseadam
Usage
adpc
Format
A data frame with 4479 rows and 130 variables:
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- SUBJID
Subject Identifier for the Study
- SITEID
Study Site Identifier
- COUNTRY
Country
- 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
Under 30 Group
- DTHA30FL
Over 30 Group
- DTHDOM
Domain for Date of Death Collection
- DTHB30FL
Over 30 plus 30 days Group
- 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
- DTHDTF
Date of Death Imputation Flag
- DTHCAUS
Cause of Death
- DTHCGR1
Cause of Death Reason 1
- DOSEP
Planned Treatment Dose
- DOSEA
Actual Treatment Dose
- DOSEU
Treatment Dose Units
- ADT
Analysis Date
- ATM
Analysis Time
- ADTM
Analysis Datetime
- ADY
Analysis Relative Day
- ATMF
Analysis Time Imputation Flag
- ASTDT
Analysis Start Date
- ASTTM
Analysis Start Time
- ASTDTM
Analysis Start Datetime
- AENDT
Analysis End Date
- AENTM
Analysis End Time
- AENDTM
Analysis End Datetime
- AVISIT
Analysis Visit
- AVISITN
Analysis Visit (N)
- ATPT
Analysis Timepoint
- ATPTN
Analysis Timepoint (N)
- ATPTREF
Analysis Timepoint Reference
- PARAM
Parameter
- PARAMCD
Parameter Code
- PARAMN
Parameter (N)
- PARCAT1
Parameter Category 1
- AVAL
Analysis Value
- AVALU
Analysis Value Unit
- AVALCAT1
Analysis Value Category 1
- BASE
Baseline Value
- BASETYPE
Baseline Type
- CHG
Change from Baseline
- DTYPE
Derivation Type
- ABLFL
Baseline Record Flag
- ANL01FL
Analysis Flag 01
- ANL02FL
Analysis Flag 02
- SRCDOM
Source Data
- SRCVAR
Source Variable
- SRCSEQ
Source Sequence Number
- NFRLT
Nom. Rel. Time from Analyte First Dose
- PCTESTCD
Pharmacokinetic Test Short Name
- PCTEST
Pharmacokinetic Test Name
- PCORRES
Result or Finding in Original Units
- PCORRESU
Original Units
- PCSTRESC
Character Result/Finding in Std Format
- PCSTRESN
Numeric Result/Finding in Standard Units
- PCSTRESU
Standard Units
- PCNAM
Vendor Name
- PCSPEC
Specimen Material Type
- PCLLOQ
Lower Limit of Quantitation
- VISIT
Visit Name
- VISITNUM
Visit Number
- VISITDY
Planned Study Day of Visit
- PCDTC
Date/Time of Specimen Collection
- PCDY
Actual Study Day of Specimen Collection
- PCTPT
Planned Time Point Name
- PCTPTNUM
Planned Time Point Number
- FANLDTM
First Datetime of Dose for Analyte
- AFRLT
Act. Rel. Time from Analyte First Dose
- ARRLT
Actual Rel. Time from Ref. Dose
- PCRFTDTM
Reference Datetime of Dose for Analyte
- FANLDT
First Date of Dose for Analyte
- FANLTM
First Time of Dose for Analyte
- PCRFTDT
Reference Date of Dose for Analyte
- PCRFTTM
Reference Time of Dose for Analyte
- NRRLT
Nominal Rel. Time from Ref. Dose
- FRLTU
Rel. Time from First Dose Unit
- RRLTU
Rel. Time from Ref. Dose Unit
- ALLOQ
Analysis Lower Limit of Quantitation
- MRRLT
Modified Rel. Time from Ref. Dose
- HTBL
Numeric Result/Finding in Standard Units
- HTBLU
Standard Units
- WTBL
Numeric Result/Finding in Standard Units
- WTBLU
Standard Units
- BMIBL
Baseline Body Mass Index (kg/m2)
- BMIBLU
BMI at Baseline (Unit)
- CRIT1
Lowest Quantification Level Criterion
- CRIT1FL
Lowest Quantification Level Flag
Source
data from pharmaverseadam.
See Also
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
Examples
head(data("adpc"))
adsl
Description
adsl modified from pharmaverseadam
Usage
adsl
Format
A data frame with 306 rows and 116 variables:
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- SUBJID
Subject Identifier for the Study
- SITEID
Study Site Identifier
- COUNTRY
Country
- 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
- 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
- DTHDTF
Date of Death Imputation Flag
- DTHCAUS
Cause of Death
- DTHCGR1
Cause of Death Reason 1
- BRTHDTC
Date/Time of Birth
- TRT01PN
Planned Treatment for Period 01 (N)
- TRT01AN
Actual Treatment for Period 01 (N)
- AGEGR1N
Pooled Age Group 1 (N)
- 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
- RFICDT
Date of Informed Consent
- STRAT1D
Description of Stratification Factor 1
- STRAT2D
Description of Stratification Factor 2
- 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
- LASTCTDT
Last Contact 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
- DTHB60FL
Death Within 60 Days of First Treatment
- UNBLNDDT
Date of Unblinding
- 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
- PKFL
Pharmacokinetic Population Flag
- DIABETFL
History of Diabetes
- IMFL
Immunogenicity Population Flag
- DCTADY
Study Day of Treatment Discontinuation
- SAFEXRS
Reason for Excl from Safety Population
- FASEXRS
Reason for Excl from Full Analysis Set
- PPREXRS
Reason for Excl from Per-Prot Population
- PKEXRES
Reason for Excl from Pharmacokin Pop
- IMEXRES
Reason for Excl from Immunogen Pop
Source
data from pharmaverseadam.
See Also
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc 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 adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
Examples
head(data("adttesaf"))
advs
Description
advs modified from pharmaverseadam
Usage
advs
Format
A data frame with 50080 rows and 90 variables:
- USUBJID
Unique Subject Identifier
- DOMAIN
Domain Abbreviation
- ASEQ
Analysis Sequence Number
- TRTP
Planned Treatment
- TRTA
Actual Treatment
- ADT
Analysis Date
- ADY
Analysis Relative Day
- AVISIT
Analysis Visit
- AVISITN
Analysis Visit (N)
- ATPT
Analysis Time Point
- ATPTN
Analysis Timepoint (N)
- PARAM
Parameter
- PARAMCD
Parameter Code
- PARAMN
Parameter (N)
- AVAL
Analysis Value
- AVALCAT1
Analysis Value Category 1
- AVALCA1N
Analysis Value Category 1 (N)
- BASETYPE
Baseline Type
- CHG
Change from Baseline
- PCHG
Percent Change from Baseline
- DTYPE
Derivation Type
- ANRIND
Analysis Reference Range Indicator
- ANRLO
Analysis Normal Range Lower Limit
- ANRHI
Analysis Normal Range Upper Limit
- A1LO
Analysis Range 1 Lower Limit
- A1HI
Analysis Range 1 Upper Limit
- ABLFL
Baseline Record Flag
- ANL01FL
Analysis Flag 01
- ONTRTFL
On Treatment Record Flag
- 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
- AVALC
Analysis Value (C)
- ASTDT
ASTDT
- 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
- CRIT4
CRIT4
- CRIT4FL
CRIT4FL
- CRIT5
CRIT5
- CRIT5FL
CRIT5FL
- CRIT6
CRIT6
- CRIT6FL
CRIT6FL
- CRIT7
CRIT7
- CRIT7FL
CRIT7FL
- CRIT8
CRIT8
- CRIT8FL
CRIT8FL
- VSCLSIG
VSCLSIG
- 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
Race
Source
data from pharmaverseadam.
See Also
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
Examples
head(data("advs"))