| Type: | Package |
| Title: | ADaM Test Data for the 'Pharmaverse' Family of Packages |
| Version: | 1.1.0 |
| Description: | A set of Analysis Data Model (ADaM) datasets constructed using the Study Data Tabulation Model (SDTM) datasets contained in the 'pharmaversesdtm' package and the template scripts from the 'admiral' family of packages. ADaM dataset specifications are described in the CDISC ADaM implementation guide, accessible by creating a free account on https://www.cdisc.org/. |
| License: | Apache License (≥ 2) |
| URL: | https://pharmaverse.github.io/pharmaverseadam/, https://github.com/pharmaverse/pharmaverseadam/ |
| Encoding: | UTF-8 |
| Language: | en-US |
| LazyData: | true |
| LazyDataCompression: | bzip2 |
| RoxygenNote: | 7.3.2 |
| Depends: | R (≥ 3.5) |
| Suggests: | covr, devtools, diffdf, DT, knitr, lintr, methods, miniUI, pkgdown, rmarkdown, roxygen2, spelling, testthat (≥ 3.0.0), tibble, usethis, metacore, metatools |
| Config/testthat/edition: | 3 |
| NeedsCompilation: | no |
| Packaged: | 2024-10-25 07:50:14 UTC; mancinie |
| Author: | Edoardo Mancini 
[aut, cre],
Kangjie Zhang [aut],
Stefan Bundfuss
[aut],
Gayatri G [aut],
Daphne Grassely [aut],
Zelos Zhu [aut],
Sadchla Mascary [aut] |
| Maintainer: | Edoardo Mancini <edoardo.mancini@roche.com> |
| Repository: | CRAN |
| Date/Publication: | 2024-10-25 08:20:02 UTC |
pharmaverseadam: ADaM Test Data for the 'Pharmaverse' Family of Packages
Description
A set of Analysis Data Model (ADaM) datasets constructed using the Study Data Tabulation Model (SDTM) datasets contained in the 'pharmaversesdtm' package and the template scripts from the 'admiral' family of packages. ADaM dataset specifications are described in the CDISC ADaM implementation guide, accessible by creating a free account on https://www.cdisc.org/.
Author(s)
Maintainer: Edoardo Mancini edoardo.mancini@roche.com (ORCID)
Authors:
Kangjie Zhang
Stefan Bundfuss (ORCID)
Gayatri G
Daphne Grassely
Zelos Zhu
Sadchla Mascary
See Also
Useful links:
adae
Description
Adverse Events Analysis
Usage
adae
Format
A data frame with 105 columns:
- STUDYID
Study Identifier
- 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
- TRTSDT
Date of First Exposure to Treatment
- TRTEDT
Date of Last Exposure to Treatment
- DTHDT
Date of Death
- EOSDT
End of Study Date
- 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
- 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
- TRTDURD
Total Treatment Duration (Days)
- SCRFDT
Screen Failure Date
- EOSSTT
End of Study Status
- FRVDT
Final Retrievel Visit Date
- RANDDT
Date of Randomization
- DTHDTF
undocumented field
- DTHADY
Relative Day of Death
- LDDTHELD
Elapsed Days from Last Dose to Death
- DTHCAUS
undocumented field
- DTHDOM
undocumented field
- DTHCGR1
undocumented field
- 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
Source
Generated from admiral package (template ad_adae.R).
References
None
Examples
data("adae")
adbcva_ophtha
Description
Best Corrected Visual Acuity Analysis
Usage
adbcva_ophtha
Format
A data frame with 120 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- OESEQ
Sequence Number
- OECAT
Category for Ophthalmic Test or Exam
- OESCAT
Subcategory for Ophthalmic Test or Exam
- OEDTC
Date/Time of Collection
- VISIT
Visit Name
- VISITNUM
Visit Number
- VISITDY
Planned Study Day of Visit
- OESTRESN
Numeric Result/Finding in Standard Units
- OESTRESC
Character Result/Finding in Std Format
- OEORRES
Result or Finding in Original Units
- OETEST
Name of Ophthalmic Test or Exam
- OETESTCD
Short Name of Ophthalmic Test or Exam
- OETSTDTL
Ophthalmic Test or Exam Detail
- OELAT
Laterality
- OELOC
Location Used for the Measurement
- OEDY
Study Day of Visit/Collection/Exam
- OEMETHOD
Method of Test or Examination
- OEORRESU
Original Units
- OESTRESU
Standard Units
- OESTAT
Completion Status
- OETPT
Planned Time Point Name
- OETPTNUM
Planned Time Point Number
- 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
- STUDYEYE
Study Eye Location
- AVAL
Analysis Value
- AVALU
Analysis Value Unit
- DTYPE
Derivation Type
- AFEYE
Affected Eye
- PARAM
Parameter
- PARAMCD
Parameter Code
- AVALC
Analysis Value (C)
- ADT
Analysis Date
- ADY
Analysis Relative Day
- ATPTN
Analysis Timepoint (N)
- ATPT
Analysis Timepoint
- AVISIT
Analysis Visit
- AVISITN
Analysis Visit (N)
- BASETYPE
Baseline Type
- ONTRTFL
On Treatment Record Flag
- ABLFL
Baseline Record Flag
- ANL01FL
Analysis Flag 01
- ANL02FL
Analysis Flag 02
- WORS01FL
Worst Post Baseline Obs
- BASE
Baseline Value
- BASEC
Baseline Value (C)
- CHG
Change from Baseline
- PCHG
Percent Change from Baseline
- 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/Region
- 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
undocumented field
- DTHADY
Relative Day of Death
- LDDTHELD
Elapsed Days from Last Dose to Death
- DTHCAUS
undocumented field
- DTHDOM
undocumented field
- DTHCGR1
undocumented field
- 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
- 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
- CRIT8
Analysis Criterion 8
- CRIT8FL
Criterion 8 Evaluation Result Flag
- AVALCA1N
Analysis Value Category 1 (N)
- AVALCAT1
Analysis Value Category 1
Source
Generated from admiralophtha package (template ad_adbcva.R).
References
None
Examples
data("adbcva_ophtha")
adce_vaccine
Description
Clinical Events Analysis for Vaccine
Usage
adce_vaccine
Format
A data frame with 56 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- CESEQ
Sequence Number
- CELNKID
Link ID
- CELNKGRP
Link Group ID
- CETERM
Reported Term for the Clinical Event
- CEDECOD
Dictionary-Derived Term
- CELAT
Laterality
- CELOC
Location of Event
- CECAT
Category for the Clinical Event
- CESCAT
Subcategory for the Clinical Event
- CEPRESP
Clinical Event Pre-specified
- CEOCCUR
Clinical Event Occurrence
- CESEV
Severity/Intensity
- CEREL
Causality
- CEOUT
Outcome of Event
- EPOCH
Epoch
- CEDTC
Date/Time of Event Collection
- CESTDTC
Start Date/Time of Clinical Event
- CEENDTC
End Date/Time of Clinical Event
- CEDUR
Duration of Clinical Event
- CETPT
Planned Time Point Name
- CETPTNUM
Planned Time Point Number
- CETPTREF
Time Point Reference
- CERFTDTC
Date/Time of Reference Time Point
- CEEVINTX
Evaluation Interval Text
- CESTAT
Completion Status
- CEREASND
Reason Clinical Event Not Collected
- TRTSDT
Date of First Exposure to Treatment
- TRTEDT
Date of Last Exposure to Treatment
- ASTDT
Analysis Start Date
- AENDT
Analysis End Date
- ASTDY
Analysis Start Relative Day
- AENDY
Analysis End Relative Day
- APERIOD
Period
- APERSDT
Period Start Date
- APEREDT
Period End Date
- APERSTDY
Analysis Sub-period Start Relative Day
- AREL
Analysis Causality
- ASEV
Analysis Severity/Intensity
- ASEVN
Analysis Severity/Intensity (N)
- AOCC01FL
Event Occurrence Flag
- ASEQ
Analysis Sequence Number
- ADURN
Analysis Duration (N)
- ADURU
Analysis Duration Units
- TRT01A
Actual Treatment for Period 01
- TRT01P
Planned Treatment for Period 01
- AGE
Age
- AGEU
Age Units
- SEX
Sex
- RACE
Race
- COUNTRY
Country
- ETHNIC
Ethnicity
- SITEID
Study Site Identifier
- SUBJID
Subject Identifier for the Study
Source
Generated from admiralvaccine package (template ad_adce.R).
References
None
Examples
data("adce_vaccine")
adcm
Description
Concomitant Medications Analysis
Usage
adcm
Format
A data frame with 95 columns:
- STUDYID
Study Identifier
- 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
undocumented field
- TRTSDT
Date of First Exposure to Treatment
- TRTEDT
Date of Last Exposure to Treatment
- DTHDT
Date of Death
- EOSDT
End of Study Date
- TRT01P
Planned Treatment for Period 01
- TRT01A
Actual Treatment for Period 01
- 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
- 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
Treatment End Datetime Imput Flag
- TRTDURD
Total Treatment Duration (Days)
- SCRFDT
Screen Failure Date
- EOSSTT
End of Study Status
- FRVDT
Final Retrievel Visit Date
- RANDDT
Date of Randomization
- DTHDTF
undocumented field
- DTHADY
Relative Day of Death
- LDDTHELD
Elapsed Days from Last Dose to Death
- DTHCAUS
undocumented field
- DTHDOM
undocumented field
- DTHCGR1
undocumented field
- 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
Source
Generated from admiral package (template ad_adcm.R).
References
None
Examples
data("adcm")
adeg
Description
Electrocardiogram Tests Analysis
Usage
adeg
Format
A data frame with 108 columns:
- STUDYID
Study Identifier
- 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
- 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
- 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
- BASE
Baseline Value
- BASEC
Baseline Value (C)
- BNRIND
Baseline Reference Range Indicator
- 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)
- CHGCAT1
Change from Baseline Category 1
- CHGCAT1N
Change from Baseline Category 1 (N)
- PARAM
Parameter
- PARAMN
Parameter (N)
- 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
undocumented field
- DTHADY
Relative Day of Death
- LDDTHELD
Elapsed Days from Last Dose to Death
- DTHCAUS
undocumented field
- DTHDOM
undocumented field
- DTHCGR1
undocumented field
- 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
Source
Generated from admiral package (template ad_adeg.R).
References
None
Examples
data("adeg")
adex
Description
Exposure Analysis
Usage
adex
Format
A data frame with 92 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- EXSEQ
Sequence Number
- EXTRT
Name of Treatment
- EXDOSE
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
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
- 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
undocumented field
- DTHADY
Relative Day of Death
- LDDTHELD
Elapsed Days from Last Dose to Death
- DTHCAUS
undocumented field
- DTHDOM
undocumented field
- DTHCGR1
undocumented field
- 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
Source
Generated from admiral package (template ad_adex.R).
References
None
Examples
data("adex")
adface_vaccine
Description
Findings About Clinical Events Analysis
Usage
adface_vaccine
Format
A data frame with 61 columns:
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- SUBJID
Subject Identifier for the Study
- SITEID
Study Site Identifier
- AGE
Age
- AGEU
Age Units
- SEX
Sex
- RACE
Race
- SAFFL
Safety Population Flag
- ARM
Description of Planned Arm
- ARMCD
Planned Arm Code
- ACTARM
Description of Actual Arm
- ACTARMCD
Actual Arm Code
- 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
- FATEST
Findings About Test Name
- FALNKID
Link ID
- FALNKGRP
Link Group ID
- FATESTCD
Findings About Test Short Name
- PARAMCD
Parameter Code
- PARAM
Parameter
- PARAMN
Parameter (N)
- FAOBJ
Object of the Observation
- PARCAT1
Parameter Category 1
- PARCAT2
Parameter Category 2
- AVALC
Analysis Value (C)
- AVAL
Analysis Value
- FASTAT
Completion Status
- FAREASND
Reason Not Performed
- FAEVAL
Evaluator
- EPOCH
Epoch
- ADT
Analysis Date
- ADTM
Analysis Datetime
- FAEVINTX
Evaluation Interval Text
- ADY
Analysis Relative Day
- ATPT
Analysis Timepoint
- ATPTN
Analysis Timepoint (N)
- ATPTREF
Analysis Timepoint Reference
- EXDOSE
Dose
- EXTRT
Name of Treatment
- EXSTDTC
Start Date/Time of Treatment
- EXENDTC
End Date/Time of Treatment
- TRTA
Actual Treatment
- TRTP
Planned Treatment
- APERIOD
Period
- APERSDT
Period Start Date
- APEREDT
Period End Date
- FAORRES
Result or Finding in Original Units
- TRT01P
Planned Treatment for Period 01
- TRT02P
Planned Treatment for Period 02
- TRT01A
Actual Treatment for Period 01
- TRT02A
Actual Treatment for Period 02
- VAX01DT
Vaccination Date 01
- VAX02DT
Vaccination Date 02
- EVENTFL
Event Value Flag
- EVENTDFL
Day Event Value Flag
- ANL01FL
Analysis Flag 01
- ANL02FL
Analysis Flag 02
- ANL03FL
undocumented field
Source
Generated from admiralvaccine package (template ad_adface.R).
References
None
Examples
data("adface_vaccine")
adis_vaccine
Description
Immunogenicity Specimen Assessments
Usage
adis_vaccine
Format
A data frame with 102 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- ISSEQ
Sequence Number
- ISTESTCD
Immunogenicity Test/Exam Short Name
- ISTEST
Immunogenicity Test or Examination Name
- ISCAT
Category for Immunogenicity Test
- ISORRES
Results or Findings in Original Units
- ISORRESU
Original Units
- ISSTRESC
Character Result/Finding in Std Format
- ISSTRESN
Numeric Results/Findings in Std. Units
- ISSTRESU
Standard Units
- ISSTAT
Completion Status
- ISREASND
Reason Not Done
- ISNAM
Vendor Name
- ISSPEC
Specimen Type
- ISMETHOD
Method of Test or Examination
- ISBLFL
Baseline Flag
- ISLLOQ
Lower Limit of Quantitation
- VISITNUM
Visit Number
- EPOCH
Epoch
- ISDTC
Date/Time of Collection
- ISDY
Study Day of Visit/Collection/Exam
- ISULOQ
Upper Limit of Quantitation
- LOD
Limit of Detection
- AVISITN
Analysis Visit (N)
- AVISIT
Analysis Visit
- ATPTN
Analysis Timepoint (N)
- ATPT
Analysis Timepoint
- ATPTREF
Analysis Timepoint Reference
- ADT
Analysis Date
- RFSTDTC
Subject Reference Start Date/Time
- PPROTFL
Per-Protocol Population Flag
- ADY
Analysis Relative Day
- PARAMCD
Parameter Code
- PARAM
Parameter
- PARAMN
Parameter (N)
- PARCAT1
Parameter Category 1
- CUTOFF02
First Cutoff Value
- CUTOFF03
Second Cutoff Value
- AVAL
Analysis Value
- AVALU
Analysis Value Unit
- SERCAT1
Pre-vaccination seropositivity status
- SERCAT1N
Pre-vaccination sero status (n)
- DTYPE
Derivation Type
- BASETYPE
Baseline Type
- BASE
Baseline Value
- ABLFL
Baseline Record Flag
- BASECAT1
Baseline Category 1
- CHG
Change from Baseline
- R2BASE
Ratio to Baseline
- CRIT1FL
Criterion 1 Evaluation Result Flag
- CRIT1FN
Criterion 1 Evaluation Result Flag (N)
- CRIT1
Analysis Criterion 1
- APERIOD
Period
- APERSDT
Period Start Date
- APEREDT
Period End Date
- TRTA
Actual Treatment
- TRTP
Planned Treatment
- PPSRFL
Per-Protocol Record-Level Flag
- SUBJID
Subject Identifier for the Study
- 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
- INVID
Investigator Identifier
- INVNAM
Investigator Name
- BRTHDTC
Date/Time of Birth
- 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
- TRT02P
Planned Treatment for Period 02
- TRT01A
Actual Treatment for Period 01
- TRT02A
Actual Treatment for Period 02
- TRTSDTM
Datetime of First Exposure to Treatment
- TRTEDTM
Datetime of Last Exposure to Treatment
- TRTSDT
Date of First Exposure to Treatment
- TRTEDT
Date of Last Exposure to Treatment
- SAFFL
Safety Population Flag
- RACEGR1
Pooled Race Group 1
- AGEGR1
Pooled Age Group 1
- REGION1
Geographic Region 1
- VAX01DT
Vaccination Date 01
- VAX02DT
Vaccination Date 02
- AP01SDT
Period 01 Start Date
- AP01EDT
Period 01 End Date
- AP02SDT
Period 02 Start Date
- AP02EDT
Period 02 End Date
Source
Generated from admiralvaccine package (template ad_adis.R).
References
None
Examples
data("adis_vaccine")
adlb
Description
Laboratory Analysis
Usage
adlb
Format
A data frame with 115 columns:
- 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
undocumented field
- DTHADY
Relative Day of Death
- LDDTHELD
Elapsed Days from Last Dose to Death
- DTHCAUS
undocumented field
- DTHDOM
undocumented field
- DTHCGR1
undocumented field
- 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
Source
Generated from admiral package (template ad_adlb.R).
References
None
Examples
data("adlb")
adlbhy
Description
Analysis of Lab Hy's Law
Usage
adlbhy
Format
A data frame with 14 columns:
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- TRT01A
Actual Treatment for Period 01
- PARAMCD
Parameter Code
- LBSEQ
Sequence Number
- ADT
Analysis Date
- AVISIT
Analysis Visit
- ADY
Analysis Relative Day
- AVAL
Analysis Value
- ANRHI
Analysis Normal Range Upper Limit
- CRIT1
Analysis Criterion 1
- CRIT1FL
Criterion 1 Evaluation Result Flag
- AVALC
Analysis Value (C)
- PARAM
Parameter
Source
Generated from admiral package (template ad_adlbhy.R).
References
None
Examples
data("adlbhy")
admh
Description
Medical History Analysis
Usage
admh
Format
A data frame with 114 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- MHSEQ
Sequence Number
- MHSPID
Sponsor-Defined Identifier
- MHTERM
Reported Term for the Medical History
- MHLLT
Lowest Level Term
- MHDECOD
Dictionary-Derived Term
- MHHLT
High Level Term
- MHHLGT
High Level Group Term
- MHCAT
Category for Medical History
- MHBODSYS
Body System or Organ Class
- MHSEV
Severity/Intensity
- VISITNUM
Visit Number
- VISIT
Visit Name
- VISITDY
Planned Study Day of Visit
- MHDTC
Date/Time of History Collection
- MHSTDTC
Start Date/Time of Medical History Event
- MHDY
Study Day of History Collection
- MHENDTC
End Date/Time of Medical History Event
- MHPRESP
Medical History Event Pre-Specified
- MHOCCUR
Medical History Occurrence
- MHSTRTPT
Start Relative to Reference Time Point
- MHENRTPT
End Relative to Reference Time Point
- MHSTTPT
Start Reference Time Point
- MHENTPT
End Reference Time Point
- MHENRF
End Relative to Reference Period
- MHSTAT
Completion Status
- 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
- DTHDT
Date of Death
- EOSDT
End of Study Date
- ASTDT
Analysis Start Date
- AENDT
Analysis End Date
- ASTDY
Analysis Start Relative Day
- AENDY
Analysis End Relative Day
- ADT
Analysis Date
- ADY
Analysis Relative Day
- SMQ02NAM
SMQ 02 Name
- SMQ02CD
SMQ 02 Code
- SMQ02SC
SMQ 02 Scope
- SMQ02SCN
SMQ 02 Scope (N)
- SMQ03NAM
SMQ 03 Name
- SMQ03CD
SMQ 03 Code
- SMQ03SC
SMQ 03 Scope
- SMQ03SCN
SMQ 03 Scope (N)
- SMQ05NAM
SMQ 05 Name
- SMQ05CD
SMQ 05 Code
- SMQ05SC
SMQ 05 Scope
- SMQ05SCN
SMQ 05 Scope (N)
- CQ01NAM
Customized Query 01 Name
- CQ04NAM
Customized Query 04 Name
- CQ04CD
Customized Query 04 Code
- AHIST
Response of Med Hx (past or current)
- AOCCFL
1st Occurrence within Subject Flag
- AOCCSFL
1st Occurrence of SOC Flag
- AOCCPFL
1st Occurrence of Preferred Term Flag
- AOCPFL
1st Occur w/in Trt Prd FL
- AOCPSFL
1st Occur of SOC w/in Trt Prd FL
- AOCPPFL
1st Occur of PT w/in Trt Prd FL
- ANL01FL
Analysis Flag 01
- TRTP
Planned Treatment
- TRTA
Actual Treatment
- APHASE
Phase
- APHASEN
Description of Phase N
- MHTERMN
Medical History Term (N)
- 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
Treatment End Datetime Imput Flag
- TRTDURD
Total Treatment Duration (Days)
- SCRFDT
Screen Failure Date
- EOSSTT
End of Study Status
- FRVDT
Final Retrievel Visit Date
- RANDDT
Date of Randomization
- DTHDTF
undocumented field
- DTHADY
Relative Day of Death
- LDDTHELD
Elapsed Days from Last Dose to Death
- DTHCAUS
undocumented field
- DTHDOM
undocumented field
- DTHCGR1
undocumented field
- 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
Source
Generated from admiral package (template ad_admh.R).
References
None
Examples
data("admh")
adoe_ophtha
Description
Exam Analysis for Ophthalmology
Usage
adoe_ophtha
Format
A data frame with 102 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- OESEQ
Sequence Number
- OECAT
Category for Ophthalmic Test or Exam
- OESCAT
Subcategory for Ophthalmic Test or Exam
- OEDTC
Date/Time of Collection
- VISIT
Visit Name
- VISITNUM
Visit Number
- VISITDY
Planned Study Day of Visit
- OESTRESN
Numeric Result/Finding in Standard Units
- OESTRESC
Character Result/Finding in Std Format
- OEORRES
Result or Finding in Original Units
- OETEST
Name of Ophthalmic Test or Exam
- OETESTCD
Short Name of Ophthalmic Test or Exam
- OETSTDTL
Ophthalmic Test or Exam Detail
- OELAT
Laterality
- OELOC
Location Used for the Measurement
- OEDY
Study Day of Visit/Collection/Exam
- OEMETHOD
Method of Test or Examination
- OEORRESU
Original Units
- OESTRESU
Standard Units
- OESTAT
Completion Status
- OETPT
Planned Time Point Name
- OETPTNUM
Planned Time Point Number
- 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
- STUDYEYE
Study Eye Location
- AVAL
Analysis Value
- AVALC
Analysis Value (C)
- AVALU
Analysis Value Unit
- DTYPE
Derivation Type
- AFEYE
Affected Eye
- PARAM
Parameter
- PARAMCD
Parameter Code
- ADT
Analysis Date
- ADY
Analysis Relative Day
- ATPTN
Analysis Timepoint (N)
- ATPT
Analysis Timepoint
- AVISIT
Analysis Visit
- AVISITN
Analysis Visit (N)
- BASETYPE
Baseline Type
- ONTRTFL
On Treatment Record Flag
- ABLFL
Baseline Record Flag
- ANL01FL
Analysis Flag 01
- ANL02FL
Analysis Flag 02
- WORS01FL
Worst Post Baseline Obs
- BASE
Baseline Value
- BASEC
Baseline Value (C)
- CHG
Change from Baseline
- PCHG
Percent Change from Baseline
- 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
undocumented field
- DTHADY
Relative Day of Death
- LDDTHELD
Elapsed Days from Last Dose to Death
- DTHCAUS
undocumented field
- DTHDOM
undocumented field
- DTHCGR1
undocumented field
- 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
Source
Generated from admiralophtha package (template ad_adoe.R).
References
None
Examples
data("adoe_ophtha")
adpc
Description
Pharmacokinetic Concentrations
Usage
adpc
Format
A data frame with 127 columns:
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- 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
- PCDTC
Date/Time of Specimen Collection
- PCDY
Actual Study Day of Specimen Collection
- PCTPT
Planned Time Point Name
- PCTPTNUM
Planned Time Point Number
- TRTSDT
Date of First Exposure to Treatment
- TRTSDTM
Datetime of First Exposure to Treatment
- TRT01P
Planned Treatment for Period 01
- TRT01A
Actual Treatment for Period 01
- ADTM
Analysis Datetime
- ATMF
Analysis Time Imputation Flag
- ADT
Analysis Date
- ATM
Analysis Time
- ADY
Analysis Relative Day
- FANLDTM
First Datetime of Dose for Analyte
- AVISITN
Analysis Visit (N)
- AVISIT
Analysis Visit
- ASTDT
Analysis Start Date
- ASTDTM
Analysis Start Datetime
- AENDT
Analysis End Date
- AENDTM
Analysis End Datetime
- ASTTM
Analysis Start Time
- AENTM
Analysis End Time
- 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
- PARCAT1
Parameter Category 1
- ATPTN
Analysis Timepoint (N)
- ATPT
Analysis Timepoint
- ATPTREF
Analysis Timepoint Reference
- ABLFL
Baseline Record Flag
- BASETYPE
Baseline Type
- DOSEA
Actual Treatment Dose
- DOSEP
Planned Treatment Dose
- DOSEU
Treatment Dose Units
- FRLTU
Rel. Time from First Dose Unit
- RRLTU
Rel. Time from Ref. Dose Unit
- PARAMCD
Parameter Code
- ALLOQ
Analysis Lower Limit of Quantitation
- AVAL
Analysis Value
- AVALU
Analysis Value Unit
- AVALCAT1
Analysis Value Category 1
- SRCDOM
Source Data
- SRCVAR
Source Variable
- SRCSEQ
Source Sequence Number
- DTYPE
Derivation Type
- MRRLT
Modified Rel. Time from Ref. Dose
- ANL01FL
Analysis Flag 01
- ANL02FL
Analysis Flag 02
- BASE
Baseline Value
- CHG
Change from Baseline
- ASEQ
Analysis Sequence Number
- PARAM
Parameter
- PARAMN
Parameter (N)
- 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)
- 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
- TRTSTMF
Time of First Exposure Imput. Flag
- TRTEDTM
Datetime of Last Exposure to Treatment
- 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
undocumented field
- DTHADY
Relative Day of Death
- LDDTHELD
Elapsed Days from Last Dose to Death
- DTHCAUS
undocumented field
- DTHDOM
undocumented field
- DTHCGR1
undocumented field
- 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
Under 30 Group
- DTHA30FL
Over 30 Group
- DTHB30FL
Over 30 plus 30 days Group
Source
Generated from admiral package (template ad_adpc.R).
References
None
Examples
data("adpc")
adpp
Description
Pharmacokinetic Parameters
Usage
adpp
Format
A data frame with 79 columns:
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- PPTESTCD
Parameter Short Name
- PPTEST
Parameter Name
- PPCAT
Parameter Category
- PPORRES
Result or Finding in Original Units
- PPORRESU
Original Units
- PPSTRESU
Standard Units
- PPSPEC
Specimen Material Type
- PPRFDTC
Date/Time of Reference Point
- TRTSDT
Date of First Exposure to Treatment
- TRTEDT
Date of Last Exposure to Treatment
- DTHDT
Date of Death
- EOSDT
End of Study Date
- TRT01P
Planned Treatment for Period 01
- TRT01A
Actual Treatment for Period 01
- ADT
Analysis Date
- ADY
Analysis Relative Day
- PARAMCD
Parameter Code
- PARCAT1
Parameter Category
- AVAL
Numeric Result/Finding in Standard Units
- AVALU
Standard Units
- SRCDOM
Domain Abbreviation
- SRCVAR
Source Variable
- SRCSEQ
Sequence Number
- AVISITN
Analysis Visit (N)
- AVISIT
Analysis Visit
- VISITNUM
Visit Number
- VISIT
Visit Name
- TRTP
Planned Treatment
- TRTA
Actual Treatment
- AVALCAT1
Analysis Value Category 1
- AVALCA1N
Analysis Value Category 1 (N)
- 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
- EOSSTT
End of Study Status
- FRVDT
Final Retrievel Visit Date
- RANDDT
Date of Randomization
- DTHDTF
undocumented field
- DTHADY
Relative Day of Death
- LDDTHELD
Elapsed Days from Last Dose to Death
- DTHCAUS
undocumented field
- DTHDOM
undocumented field
- DTHCGR1
undocumented field
- 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
Source
Generated from admiral package (template ad_adpp.R).
References
None
Examples
data("adpp")
adppk
Description
Population Pharmacokinetic
Usage
adppk
Format
A data frame with 61 columns:
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- EVID
Event ID
- NFRLT
Nom. Rel. Time from Analyte First Dose
- AFRLT
Act. Rel. Time from Analyte First Dose
- APRLT
Actual Rel Time from Previous Dose
- NPRLT
Nominal Rel Time from Previous Dose
- DOSEA
Actual Treatment Dose
- DOSEP
Planned Treatment Dose
- PARAMCD
Parameter Code
- ALLOQ
Analysis Lower Limit of Quantitation
- CMT
Compartment
- BLQFL
Below Lower Limit of Quant Flag
- BLQFN
Below Lower Limit of Quant Flag (N)
- AMT
Actual Amount of Dose Received (unit)
- DV
Dependent Variable Result
- AVAL
Analysis Value
- DVL
Log DV
- MDV
Missing Dependent Variable Result
- AVALU
Analysis Value Unit
- UDTC
Date/Time
- II
Dosing Interval (unit)
- SS
Steady State
- ASEQ
Analysis Sequence Number
- PARAM
Parameter
- PARAMN
Parameter (N)
- PROJID
Project Identifier
- PROJIDN
Project Identifier (N)
- STUDYIDN
Study Identifier (N)
- SITEID
Study Site Identifier
- SITEIDN
Study Site Identifier (N)
- USUBJIDN
Unique Subject Identifier (N)
- SUBJID
Subject Identifier for the Study
- SUBJIDN
Subject Identifier for the Study (N)
- AGE
Age
- SEX
Sex
- SEXN
Sex (N)
- COHORT
Cohort Subject Enrolled Into
- COHORTC
Description of Planned Arm
- ROUTE
Route of Administration
- ROUTEN
Route of Administration (N)
- RACE
Race
- RACEN
Race (N)
- ETHNIC
Ethnicity
- ETHNICN
Ethnicity (N)
- FORM
Drug Formulation
- FORMN
Drug Formulation (N)
- COUNTRY
Country
- COUNTRYN
Country (N)
- COUNTRYL
Country Name
- HTBL
Numeric Result/Finding in Standard Units
- WTBL
Numeric Result/Finding in Standard Units
- ALTBL
Numeric Result/Finding in Standard Units
- ASTBL
Numeric Result/Finding in Standard Units
- TBILBL
Numeric Result/Finding in Standard Units
- CREATBL
Numeric Result/Finding in Standard Units
- BMIBL
Baseline Body Mass Index (kg/m2)
- BSABL
Numeric Result/Finding in Standard Units
- CRCLBL
Baseline Creatinine Clearance
- EGFRBL
Age
- RECSEQ
Record Sequence
Source
Generated from admiral package (template ad_adppk.R).
References
None
Examples
data("adppk")
adrs_onco
Description
Tumor Response Analysis
Usage
adrs_onco
Format
A data frame with 79 columns:
- DOMAIN
Domain Abbreviation
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- 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
- RANDDT
Date of Randomization
- PARAMCD
Parameter Code
- PARAM
Parameter
- PARCAT1
Parameter Category 1
- PARCAT2
Parameter Category 2
- PARCAT3
Parameter Category 3
- ADT
Analysis Date
- ADTF
Analysis Date Imputation Flag
- AVISIT
Analysis Visit
- AVALC
Analysis Value (C)
- AVAL
Analysis Value
- ANL01FL
Analysis Flag 01
- ANL02FL
Analysis Flag 02
- 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
- 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
- DTHDT
Date of Death
- DTHDTF
Date of Death Imputation Flag
- DTHADY
Relative Day of Death
- LDDTHELD
Elapsed Days from Last Dose to Death
- DTHCAUS
Cause of Death
- DTHDOM
Domain for Date of Death Collection
- DTHCGR1
Cause of Death Reason 1
- 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
Source
Generated from admiralonco package (template ad_adrs.R).
References
None
Examples
data("adrs_onco")
adsl
Description
Subject Level Analysis
Usage
adsl
Format
A data frame with 54 columns:
- 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
undocumented field
- DTHDOM
undocumented field
- DTHCGR1
undocumented field
- 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
Source
Generated from admiral package (template ad_adsl.R).
References
None
Examples
data("adsl")
adsl_vaccine
Description
Subject Level Analysis for Vaccine
Usage
adsl_vaccine
Format
A data frame with 46 columns:
- 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
- INVID
Investigator Identifier
- INVNAM
Investigator Name
- BRTHDTC
Date/Time of Birth
- 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/Region
- DMDTC
Date/Time of Collection
- DMDY
Study Day of Collection
- TRT01P
Planned Treatment for Period 01
- TRT02P
Planned Treatment for Period 02
- TRT01A
Actual Treatment for Period 01
- TRT02A
Actual Treatment for Period 02
- TRTSDTM
Datetime of First Exposure to Treatment
- TRTEDTM
Datetime of Last Exposure to Treatment
- TRTSDT
Date of First Exposure to Treatment
- TRTEDT
Date of Last Exposure to Treatment
- SAFFL
Safety Population Flag
- PPROTFL
Per-Protocol Population Flag
- RACEGR1
Pooled Race Group 1
- AGEGR1
Pooled Age Group 1
- REGION1
Geographic Region 1
- VAX01DT
Vaccination Date 01
- VAX02DT
Vaccination Date 02
- AP01SDT
Period 01 Start Date
- AP01EDT
Period 01 End Date
- AP02SDT
Period 02 Start Date
- AP02EDT
Period 02 End Date
Source
Generated from admiralvaccine package (template ad_adsl.R).
References
None
Examples
data("adsl_vaccine")
adtr_onco
Description
Tumor Results Analysis for Oncology
Usage
adtr_onco
Format
A data frame with 99 columns:
- DOMAIN
Domain Abbreviation
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- 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
- VISITNUM
Visit Number
- VISIT
Visit Name
- TREVAL
Evaluator
- TREVALID
Evaluator Identifier
- TRACPTFL
Accepted Record Flag
- TRDTC
Date/Time of Tumor/Lesion Measurement
- TRSEQ
Sequence Number
- RANDDT
Date of Randomization
- TULOC
Location of the Tumor/Lesion
- TULOCGR1
Tumor Site Group 1
- LSEXP
Lesion IDs Expected
- LSASS
Lesion IDs Assessed
- ADT
Analysis Date
- ADTF
Analysis Date Imputation Flag
- ADY
Analysis Relative Day
- AVISIT
Analysis Visit
- AVISITN
Analysis Visit (N)
- PARAMCD
Parameter Code
- PARAM
Parameter
- PARCAT1
Parameter Category 1
- PARCAT2
Parameter Category 2
- PARCAT3
Parameter Category 3
- AVAL
Analysis Value
- ANL01FL
Analysis Flag 01
- ABLFL
Baseline Record Flag
- BASE
Baseline Value
- NADIR
NADIR
- CHG
Change from Baseline
- PCHG
Percent Change from Baseline
- CHGNAD
Change from NADIR
- PCHGNAD
Percent Change from NADIR
- PDFL
Pharmacodynamic Analysis Set Flag
- ANL02FL
Analysis Flag 02
- ANL03FL
Analysis Flag 03
- ANL04FL
Analysis Flag 04
- 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
- 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
- DTHDT
Date of Death
- DTHDTF
Date of Death Imputation Flag
- DTHADY
Relative Day of Death
- LDDTHELD
Elapsed Days from Last Dose to Death
- DTHCAUS
Cause of Death
- DTHDOM
Domain for Date of Death Collection
- DTHCGR1
Cause of Death Reason 1
- 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
Source
Generated from admiralonco package (template ad_adtr.R).
References
None
Examples
data("adtr_onco")
adtte_onco
Description
Time to Event Analysis for Oncology
Usage
adtte_onco
Format
A data frame with 20 columns:
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- ADT
Analysis Date
- EVNTDESC
Event or Censoring Description
- SRCDOM
Source Data
- SRCVAR
Source Variable
- SRCSEQ
Source Sequence Number
- CNSR
Censor
- CNSDTDSC
Censor Date Description
- STARTDT
Time-to-Event Origin Date for Subject
- PARAMCD
Parameter Code
- PARAM
Parameter
- AVAL
Analysis Value
- ASEQ
Analysis Sequence Number
- ARMCD
Planned Arm Code
- ARM
Description of Planned Arm
- ACTARMCD
Actual Arm Code
- ACTARM
Description of Actual Arm
- AGE
Age
- SEX
Sex
Source
Generated from admiralonco package (template ad_adtte.R).
References
None
Examples
data("adtte_onco")
advfq_ophtha
Description
Visual Function Questionnaire Analysis
Usage
advfq_ophtha
Format
A data frame with 89 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- QSSEQ
Sequence Number
- QSTESTCD
Question Short Name
- QSTEST
Question Name
- QSCAT
Category of Question
- QSSCAT
Subcategory for Question
- QSORRES
Finding in Original Units
- QSORRESU
Original Units
- QSSTRESC
Character Result/Finding in Std Format
- QSSTRESN
Numeric Finding in Standard Units
- QSSTRESU
Standard Units
- QSBLFL
Baseline Flag
- QSDRVFL
Derived Flag
- VISITNUM
Visit Number
- VISIT
Visit Name
- VISITDY
Planned Study Day of Visit
- QSDTC
Date/Time of Finding
- QSDY
Study Day of Finding
- 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
- AVAL
Analysis Value
- AVALC
Analysis Value (C)
- AVISIT
Analysis Visit
- AVISITN
Analysis Visit (N)
- ONTRTFL
On Treatment Record Flag
- ABLFL
Baseline Record Flag
- BASE
Baseline Value
- CHG
Change from Baseline
- PCHG
Percent Change from Baseline
- ANL01FL
Analysis Flag 01
- ASEQ
Analysis Sequence Number
- PARAM
Parameter
- PARCAT1
Parameter Category 1
- PARCAT2
Parameter Category 2
- 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
undocumented field
- DTHADY
Relative Day of Death
- LDDTHELD
Elapsed Days from Last Dose to Death
- DTHCAUS
undocumented field
- DTHDOM
undocumented field
- DTHCGR1
undocumented field
- 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
Source
Generated from admiralophtha package (template ad_advfq.R).
References
None
Examples
data("advfq_ophtha")
advs
Description
Vital Signs Analysis
Usage
advs
Format
A data frame with 105 columns:
- STUDYID
Study Identifier
- 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
- 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
- AVAL
Analysis Value
- 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
- A1LO
Analysis Range 1 Lower Limit
- A1HI
Analysis Range 1 Upper Limit
- ANRIND
Analysis Reference Range Indicator
- BASETYPE
Baseline Type
- ABLFL
Baseline Record Flag
- BASE
Baseline Value
- BNRIND
Baseline Reference Range Indicator
- 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)
- 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
undocumented field
- DTHADY
Relative Day of Death
- LDDTHELD
Elapsed Days from Last Dose to Death
- DTHCAUS
undocumented field
- DTHDOM
undocumented field
- DTHCGR1
undocumented field
- 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
Source
Generated from admiral package (template ad_advs.R).
References
None
Examples
data("advs")
advs_peds
Description
Vital Signs Analysis for Pediatrics
Usage
advs_peds
Format
A data frame with 80 columns:
- STUDYID
Study Identifier
- 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
- VSEVAL
Evaluator
- EPOCH
Epoch
- SEX
Sex
- BRTHDTC
Date/Time of Birth (Character)
- 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
- BRTHDT
Date/Time of Birth
- ADT
Analysis Date
- ADY
Analysis Relative Day
- AAGECUR
Current Analysis Age (Days)
- AAGECURU
Current Analysis Age Units
- PARAMCD
Parameter Code
- AVAL
Analysis Value
- ATPTN
Analysis Timepoint (N)
- ATPT
Analysis Timepoint
- AVISIT
Analysis Visit
- AVISITN
Analysis Visit (N)
- HGTTMP
Temporary Height at Timepoint
- HGTTMPU
Temporary Height at Timepoint Units
- PARAM
Parameter
- PARAMN
Parameter (N)
- ABLFL
Baseline Record Flag
- BASE
Baseline Value
- CHG
Change from Baseline
- PCHG
Percent Change from Baseline
- ONTRTFL
On Treatment Record Flag
- ANL01FL
Analysis Flag 01
- 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
- 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)
- ASEQ
Analysis Sequence Number
Source
Generated from admiralpeds package (template ad_advs.R).
References
None
Examples
data("advs_peds")