Help for package pharmaverseadam

Type:

Package

Title:

ADaM Test Data for the 'Pharmaverse' Family of Packages

Version:

1.2.0

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/

Depends:

R (≥ 3.5)

Imports:

tibble

Suggests:

cli, covr, devtools, diffdf, DT, jsonlite, knitr, lintr, metacore, metatools, methods, miniUI, pkgdown, readxl, rmarkdown, roxygen2, spelling, testthat (≥ 3.0.0), usethis

Config/testthat/edition:

Encoding:

UTF-8

Language:

en-US

LazyData:

true

LazyDataCompression:

bzip2

RoxygenNote:

7.3.2

NeedsCompilation:

Packaged:

2025-09-05 09:47:58 UTC; fanny.gautier

Author:

Fanny Gautier

[aut, cre], Stefan Bundfuss

[aut], Edoardo Mancini

[aut], Lina Patil [aut], Vladyslav Shuliar

[aut], Cytel Inc. [cph, fnd], F. Hoffmann-La Roche AG [cph, fnd], GlaxoSmithKline LLC [cph, fnd]

Maintainer:

Fanny Gautier <fanny.gautier@cytel.com>

Repository:

CRAN

Date/Publication:

2025-09-06 05:11:18 UTC

pharmaverseadam: ADaM Test Data for the 'Pharmaverse' Family of Packages

Description

Author(s)

Maintainer: Fanny Gautier fanny.gautier@cytel.com (ORCID)

Authors:

Stefan Bundfuss (ORCID)
Edoardo Mancini edoardo.mancini@roche.com (ORCID)
Lina Patil lina.patil@cytel.com
Vladyslav Shuliar (ORCID)

Other contributors:

Cytel Inc. [copyright holder, funder]
F. Hoffmann-La Roche AG [copyright holder, funder]
GlaxoSmithKline LLC [copyright holder, funder]

Adverse Events Analysis

Description

Adverse Events Analysis

Usage

adae

Format

A data frame with 107 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
DOSEON: Treatment Dose
DOSEU: Treatment Dose Unit
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 Retrieval Visit Date
RANDDT: Date of Randomization
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 admiral package (template ad_adae.R).

References

None

Examples

data("adae")

Best Corrected Visual Acuity Analysis

Description

Best Corrected Visual Acuity Analysis

Usage

adbcva_ophtha

Format

A data frame with 71 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
CRIT1FL: Criterion 1 Evaluation Result Flag
CRIT1: Analysis Criterion 1
CRIT2FL: Criterion 2 Evaluation Result Flag
CRIT2: Analysis Criterion 2
CRIT3FL: Criterion 3 Evaluation Result Flag
CRIT3: Analysis Criterion 3
CRIT4FL: Criterion 4 Evaluation Result Flag
CRIT4: Analysis Criterion 4
CRIT5FL: Criterion 5 Evaluation Result Flag
CRIT5: Analysis Criterion 5
CRIT6FL: Criterion 6 Evaluation Result Flag
CRIT6: Analysis Criterion 6
CRIT7FL: Criterion 7 Evaluation Result Flag
CRIT7: Analysis Criterion 7
CRIT8FL: Criterion 8 Evaluation Result Flag
CRIT8: Analysis Criterion 8
AVALCA1N: Analysis Value Category 1 (N)
AVALCAT1: Analysis Value Category 1

Details

Contains a set of 4 unique Parameter Codes and Parameters:

PARAMCD	PARAM
FBCVA	Fellow Eye Visual Acuity Score (letters)
FBCVALOG	Fellow Eye Visual Acuity LogMAR Score
SBCVA	Study Eye Visual Acuity Score (letters)
SBCVALOG	Study Eye Visual Acuity LogMAR Score

Source

Generated from admiralophtha package (template ad_adbcva.R).

References

None

Examples

data("adbcva_ophtha")

Clinical Events Analysis for 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")

Concomitant Medications Analysis

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: End Relative to Reference Time 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
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 Retrieval Visit Date
RANDDT: Date of Randomization
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 admiral package (template ad_adcm.R).

References

None

Examples

data("adcm")

Questionnaires Analysis for Metabolic

Description

Questionnaires Analysis for Metabolic

Usage

adcoeq_metabolic

Format

A data frame with 85 columns:

STUDYID: Study Identifier
USUBJID: Unique Subject Identifier
DOMAIN: Domain Abbreviation
VISIT: Visit Name
VISITNUM: Visit Number
VISITDY: Planned Study Day of Visit
QSBLFL: Baseline Flag
QSDTC: Date/Time of Finding
QSDY: Study Day of Finding
QSCAT: Category for Questionnaire
QSTEST: Questionnaire Test Name
QSTESTCD: Questionnaire Test Short Name
QSORRES: Result or Finding in Original Units
QSORRESU: Original Units
QSSTRESC: Character Result/Finding in Std Format
QSSTRESN: Numeric Result/Finding in Standard Units
QSSTRESU: Standard Units
QSSEQ: Sequence Number
TRTSDT: Date of First Exposure to Treatment
TRTEDT: Date of Last Exposure to Treatment
TRT01P: Planned Treatment for Period 01
TRT01A: Actual Treatment for Period 01
PARAMCD: Parameter Code
PARAM: Parameter
PARAMN: Parameter (N)
PARCAT1: Parameter Category 1
ADT: Analysis Date
ADY: Analysis Relative Day
AVISIT: Analysis Visit
AVISITN: Analysis Visit (N)
AVAL: Analysis Value
AVALC: Analysis Value (C)
ABLFL: Baseline Record Flag
BASE: Baseline Value
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 Retrieval 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: 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

Details

Contains a set of 25 unique Parameter Codes and Parameters:

PARAMCD	PARAM
COEQ01	How hungry have you felt?
COEQ02	How full have you felt?
COEQ03	How strong was your desire to eat sweet foods?
COEQ04	How strong was your desire to eat savoury foods?
COEQ05	How happy have you felt?
COEQ06	How anxious have you felt?
COEQ07	How alert have you felt?
COEQ08	How contented have you felt?
COEQ09	During the last 7 days how often have you had food cravings?
COEQ10	How strong have any food cravings been?
COEQ11	How difficult has it been to resist any food cravings?
COEQ12	How often have you eaten in response to food cravings?
COEQ13	Chocolate or chocolate flavoured foods
COEQ14	Other sweet foods (cakes, pastries, biscuits, etc)
COEQ15	Fruit or fruit juice
COEQ16	Dairy foods (cheese, yoghurts, milk, etc)
COEQ17	Starchy foods (bread, rice, pasta, etc)
COEQ18	Savoury foods (french fries, crisps, burgers, pizza, etc)
COEQ19	Generally, how difficult has it been to control your eating?
COEQ20	Which one food makes it most difficult for you to control eating?
COEQ21	How difficult has it been to resist eating this food during the last 7 days?
COEQCRCO	COEQ - Craving Control
COEQCRSA	COEQ - Craving for Savoury
COEQCRSW	COEQ - Craving for Sweet
COEQPOMO	COEQ - Positive Mood

Source

Generated from admiralmetabolic package (template ad_adcoeq.R).

References

None

Examples

data("adcoeq_metabolic")

Electrocardiogram Tests Analysis

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 Retrieval 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: 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

Details

Contains a set of 8 unique Parameter Codes and Parameters:

PARAMCD	PARAM
EGINTP	ECG Interpretation
HR	Heart Rate (beats/min)
QT	QT Duration (ms)
QTCBR	QTcB - Bazett's Correction Formula Rederived (ms)
QTCFR	QTcF - Fridericia's Correction Formula Rederived (ms)
QTLCR	QTlc - Sagie's Correction Formula Rederived (ms)
RR	RR Duration (ms)
RRR	RR Duration Rederived (ms)

Source

Generated from admiral package (template ad_adeg.R).

References

None

Examples

data("adeg")

Exposure Analysis

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 Retrieval 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: 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

Details

Contains a set of 19 unique Parameter Codes and Parameters:

PARAMCD	PARAM
ADJ	Dose adjusted during constant dosing interval
ADJAE	Dose adjusted due to AE during constant dosing interval
AVDDSE	Average daily dose administered (mg/mg)
DOSE	Dose administered during constant dosing interval (mg)
DURD	Study drug duration during constant dosing interval (days)
PADJ	Dose adjusted during W2-W24
PADJAE	Dose adjusted in W2-W24 due to AE
PAVDDSE	Average daily dose administered in W2-W24 (mg)
PDOSE	Total dose administered in W2-W2 (mg)4
PDOSINT	W2-24 dose intensity (%)
PDURD	Overall duration in W2-W24 (days)
PLDOSE	Planned dose during constant dosing interval (mg)
PPDOSE	Total planned dose in W2-W24 (mg)
TADJ	Dose adjusted during study
TADJAE	Dose adjusted during study due to AE
TDOSE	Total dose administered (mg)
TDOSINT	Overall dose intensity (%)
TDURD	Overall duration (days)
TPDOSE	Total planned dose (mg)

Source

Generated from admiral package (template ad_adex.R).

References

None

Examples

data("adex")

Findings About Clinical Events Analysis

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: Analysis Flag 03

Details

Contains a set of 30 unique Parameter Codes and Parameters:

PARAMCD	PARAM
DIARE	Redness diameter deltoid muscle left
DIASWEL	Swelling diameter deltoid muscle left
MAXREDN	Redness maximum severity deltoid muscle left
MAXSFAT	Fatigue maximum severity
MAXSHEA	Headache maximum severity
MAXSPIS	Pain at injection site maximum severity deltoid muscle left
MAXSWEL	Swelling maximum severity deltoid muscle left
MAXTEMP	Fever maximum temperature
MDIRE	Redness maximum diameter deltoid muscle left
MDISW	Swelling maximum diameter deltoid muscle left
MSEVNWJP	New or worsened joint pain maximum severity
MSEVNWMP	New or worsened muscle pain maximum severity
OCCHILLS	Chills occurrence indicator
OCCNWJP	New or worsened joint pain occurrence indicator
OCCNWMP	New or worsened muscle pain occurrence indicator
OCCVOM	Vomiting occurrence indicator
OCDIAR	Diarrhea occurrence indicator
OCFATIG	Fatigue occurrence indicator
OCFEVER	Fever occurrence indicator
OCHEAD	Headache occurrence indicator
OCINS	Swelling occurrence indicator deltoid muscle left
OCISR	Redness occurrence indicator deltoid muscle left
OCPIS	Pain at injection site occurrence indicator deltoid muscle left
SEVFAT	Fatigue severity/intensity
SEVHEAD	Headache severity/intensity
SEVNWJP	New or worsened joint pain severity/intensity
SEVNWMP	New or worsened muscle pain severity/intensity
SEVPIS	Pain at injection site severity/intensity deltoid muscle left
SEVREDN	Redness severity/intensity deltoid muscle left
SEVSWEL	Swelling severity/intensity deltoid muscle left

Source

Generated from admiralvaccine package (template ad_adface.R).

References

None

Examples

data("adface_vaccine")

Immunogenicity Specimen Assessments

Description

Immunogenicity Specimen Assessments

Usage

adis_vaccine

Format

A data frame with 104 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
IDVARVAL: Identifying Variable Value
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
DERIVED: Derivation Method
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
ABLFL: Baseline Record Flag
BASE: Baseline Value
BASETYPE: Baseline Type
BASECAT1: Baseline Category 1
CHG: Change from Baseline
R2BASE: Ratio to Baseline
CRIT1FL: Criterion 1 Evaluation Result Flag
CRIT1: Analysis Criterion 1
CRIT1FN: Criterion 1 Evaluation Result Flag (N)
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

Details

Contains a set of 16 unique Parameter Codes and Parameters:

PARAMCD	PARAM
I0019NLF	LOG10 4FOLD (I0019NT Antibody)
I0019NT	I0019NT Antibody
I0019NTF	4FOLD (I0019NT Antibody)
I0019NTL	LOG10 (I0019NT Antibody)
J0033VLF	LOG10 4FOLD (J0033VN Antibody)
J0033VN	J0033VN Antibody
J0033VNF	4FOLD (J0033VN Antibody)
J0033VNL	LOG10 (J0033VN Antibody)
M0019LLF	LOG10 4FOLD (M0019LN Antibody)
M0019LN	M0019LN Antibody
M0019LNF	4FOLD (M0019LN Antibody)
M0019LNL	LOG10 (M0019LN Antibody)
R0003MA	R0003MA Antibody
R0003MAF	4FOLD (R0003MA Antibody)
R0003MAL	LOG10 (R0003MA Antibody)
R0003MLF	LOG10 4FOLD (R0003MA Antibody)

Source

Generated from admiralvaccine package (template ad_adis.R).

References

None

Examples

data("adis_vaccine")

Laboratory Analysis

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 Retrieval 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: 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

Details

Contains a set of 47 unique Parameter Codes and Parameters:

PARAMCD	PARAM
ALB	Albumin (g/L)
ALKPH	Alkaline Phosphatase (U/L)
ALT	Alanine Aminotransferase (U/L)
ANISO	Anisocytes
AST	Aspartate Aminotransferase (U/L)
BASO	Basophils Abs (10^9/L)
BASOLE	Basophils/Leukocytes (FRACTION)
BILI	Bilirubin (umol/L)
BUN	Blood Urea Nitrogen (mmol/L)
CA	Calcium (mmol/L)
CHOLES	Cholesterol (mmol/L)
CK	Creatinine Kinase (U/L)
CL	Chloride (mmol/L)
COLOR	Color
CREAT	Creatinine (umol/L)
EOS	Eosinophils (10^9/L)
EOSLE	Eosinophils/Leukocytes (FRACTION)
GGT	Gamma Glutamyl Transferase (U/L)
GLUC	Glucose (mmol/L)
HBA1C	Hemoglobin A1C (1)
HCT	Hematocrit (1)
HGB	Hemoglobin (mmol/L)
KETON	Ketones
LYMPH	Lymphocytes Abs (10^9/L)
LYMPHLE	Lymphocytes/Leukocytes (FRACTION)
MACROC	Macrocytes
MCH	Ery. Mean Corpuscular Hemoglobin (fmol(Fe))
MCHC	Ery. Mean Corpuscular HGB Concentration (mmol/L)
MCV	Ery. Mean Corpuscular Volume (f/L)
MICROC	Microcytes
MONO	Monocytes (10^9/L)
MONOLE	Monocytes/Leukocytes (FRACTION)
PH	pH
PHOS	Phosphate (mmol/L)
PLAT	Platelet (10^9/L)
POIKIL	Poikilocytes
POLYCH	Polychromasia
POTAS	Potassium (mmol/L)
PROT	Protein (g/L)
RBC	Erythrocytes (TI/L)
SODIUM	Sodium (mmol/L)
SPGRAV	Specific Gravity
TSH	Thyrotropin (mU/L)
URATE	Urate (umol/L)
UROBIL	Urobilinogen
VITB12	Vitamin B12 (pmol/L)
WBC	Leukocytes (10^9/L)

Source

Generated from admiral package (template ad_adlb.R).

References

None

Examples

data("adlb")

Laboratory Analysis for Metabolic

Description

Laboratory Analysis for Metabolic

Usage

adlb_metabolic

Format

A data frame with 43 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
LBFAST: Fasting Status
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
PARAMCD: Parameter Code
PARAM: Parameter
PARAMN: Parameter (N)
ADT: Analysis Date
ADY: Analysis Relative Day
AVISIT: Analysis Visit
AVISITN: Analysis Visit (N)
PARCAT1: Parameter Category 1
AVAL: Analysis Value
AVALC: Analysis Value (C)
ANRLO: Analysis Normal Range Lower Limit
ANRHI: Analysis Normal Range Upper Limit
PARCAT2: Parameter Category 2
BMI: Body Mass Index (kg/m2)
WSTCIR: Waist Circumference (cm)

Details

Contains a set of 11 unique Parameter Codes and Parameters:

PARAMCD	PARAM
ALB	Albumin (g/L)
ALKPH	Alkaline Phosphatase (U/L)
AST	Aspartate Aminotransferase (U/L)
CHOLES	Cholesterol (mmol/L)
FLI	Fatty Liver Index
GGT	Gamma Glutamyl Transferase (U/L)
GLUC	Glucose (mmol/L)
HBA1CHGB	Hemoglobin A1C/Hemoglobin (mmol/mol)
HOMAIR	Homeostasis Model Assessment - Insulin Resistance
INSULIN	Insulin (mIU/L)
TRIG	Triglycerides (mg/dL)

Source

Generated from admiralmetabolic package (template ad_adlb.R).

References

None

Examples

data("adlb_metabolic")

Analysis of Lab Hy's Law

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
PARAM: Parameter
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)

Details

Contains a set of 4 unique Parameter Codes and Parameters:

PARAMCD	PARAM
ALT	Alanine Aminotransferase (U/L)
AST	Aspartate Aminotransferase (U/L)
BILI	Bilirubin (umol/L)
HYSLAW	ALT/AST >= 3xULN and BILI >= 2xULN

Source

Generated from admiral package (template ad_adlbhy.R).

References

None

Examples

data("adlbhy")

Medical History Analysis

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 Retrieval Visit Date
RANDDT: Date of Randomization
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 admiral package (template ad_admh.R).

References

None

Examples

data("admh")

Exam Analysis for Ophthalmology

Description

Exam Analysis for Ophthalmology

Usage

adoe_ophtha

Format

A data frame with 103 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
PARAMN: Parameter (N)
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 Retrieval 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: 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

Details

Contains a set of 8 unique Parameter Codes and Parameters:

PARAMCD	PARAM
FCSUBTH	Fellow Eye Center Subfield Thickness (um)
FDRSSR	Fellow Eye Diabetic Retinopathy Severity
FIOP	Fellow Eye IOP (mmHg)
FIOPCHG	Fellow Eye IOP Pre to Post Dose Diff (mmHg)
SCSUBTH	Study Eye Center Subfield Thickness (um)
SDRSSR	Study Eye Diabetic Retinopathy Severity
SIOP	Study Eye IOP (mmHg)
SIOPCHG	Study Eye IOP Pre to Post Dose Diff (mmHg)

Source

Generated from admiralophtha package (template ad_adoe.R).

References

None

Examples

data("adoe_ophtha")

Pharmacokinetic Concentrations

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
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
ABLFL: Baseline Record Flag
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 Retrieval 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: 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: Under 30 Group
DTHA30FL: Over 30 Group
DTHB30FL: Over 30 plus 30 days Group

Details

Contains a set of 2 unique Parameter Codes and Parameters:

PARAMCD	PARAM
DOSE	Xanomeline Patch Dose
XAN	Pharmacokinetic concentration of Xanomeline

Source

Generated from admiral package (template ad_adpc.R).

References

None

Examples

data("adpc")

Pharmacokinetic Parameters

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 Retrieval Visit Date
RANDDT: Date of Randomization
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 admiral package (template ad_adpp.R).

References

None

Examples

data("adpp")

Population Pharmacokinetic

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

Details

Contains a set of 2 unique Parameter Codes and Parameters:

PARAMCD	PARAM
DOSE	Xanomeline Patch Dose
XAN	Pharmacokinetic concentration of Xanomeline

Source

Generated from admiral package (template ad_adppk.R).

References

None

Examples

data("adppk")

Tumor Response Analysis

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 Retrieval 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

Details

Contains a set of 13 unique Parameter Codes and Parameters:

PARAMCD	PARAM
BCP	Best Overall Response of CR/PR by Investigator (confirmation not required)
BOR	Best Overall Response by Investigator (confirmation not required)
CB	Clinical Benefit by Investigator (confirmation for response not required)
CBCP	Best Confirmed Overall Response of CR/PR by Investigator
CBOR	Best Confirmed Overall Response by Investigator
CCB	Confirmed Clinical Benefit by Investigator
CRSP	Confirmed Response by Investigator
DEATH	Death
LSTA	Last Disease Assessment by Investigator
MDIS	Measurable Disease at Baseline by Investigator
OVR	Overall Response by Investigator
PD	Disease Progression by Investigator
RSP	Response by Investigator (confirmation not required)

Source

Generated from admiralonco package (template ad_adrs.R).

References

None

Examples

data("adrs_onco")

Subject Level Analysis

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 Retrieval 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: 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 admiral package (template ad_adsl.R).

References

None

Examples

data("adsl")

Subject Level Analysis for 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")

Tumor Results Analysis for Oncology

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 Retrieval 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

Details

Contains a set of 11 unique Parameter Codes and Parameters:

PARAMCD	PARAM
LDIAM1	Target Lesion 1 Analysis Diameter
LDIAM2	Target Lesion 2 Analysis Diameter
LDIAM3	Target Lesion 3 Analysis Diameter
LDIAM4	Target Lesion 4 Analysis Diameter
LDIAM5	Target Lesion 5 Analysis Diameter
NLDIAM1	Target Lesion 1 Analysis Perpendicular
NLDIAM2	Target Lesion 2 Analysis Perpendicular
NLDIAM3	Target Lesion 3 Analysis Perpendicular
NLDIAM4	Target Lesion 4 Analysis Perpendicular
NLDIAM5	Target Lesion 5 Analysis Perpendicular
SDIAM	Target Lesions Sum of Diameters by Investigator

Source

Generated from admiralonco package (template ad_adtr.R).

References

None

Examples

data("adtr_onco")

Time to Event Analysis for Oncology

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

Details

Contains a set of 3 unique Parameter Codes and Parameters:

PARAMCD	PARAM
OS	Overall Survival
PFS	Progression Free Survival
RSD	Duration of Response

Source

Generated from admiralonco package (template ad_adtte.R).

References

None

Examples

data("adtte_onco")

Visual Function Questionnaire Analysis

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 Retrieval 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: 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

Details

Contains a set of 11 unique Parameter Codes and Parameters:

PARAMCD	PARAM
QBCSCORE	Composite Score
QR01	Recoded Item - 01
QR02	Recoded Item - 02
QR03	Recoded Item - 03
QR04	Recoded Item - 04
QSG01	General Score 01
QSG02	General Score 02
VFQ1	Overall Health
VFQ2	Eyesight in Both Eyes
VFQ3	Worry About Eyesight
VFQ4	Pain in and Around Eyes

Source

Generated from admiralophtha package (template ad_advfq.R).

References

None

Examples

data("advfq_ophtha")

Vital Signs Analysis

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 Retrieval 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: 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

Details

Contains a set of 9 unique Parameter Codes and Parameters:

PARAMCD	PARAM
BMI	Body Mass Index(kg/m^2)
BSA	Body Surface Area(m^2)
DIABP	Diastolic Blood Pressure (mmHg)
HEIGHT	Height (cm)
MAP	Mean Arterial Pressure (mmHg)
PULSE	Pulse Rate (beats/min)
SYSBP	Systolic Blood Pressure (mmHg)
TEMP	Temperature (C)
WEIGHT	Weight (kg)

Source

Generated from admiral package (template ad_advs.R).

References

None

Examples

data("advs")

Vital Signs Analysis for Metabolic

Description

Vital Signs Analysis for Metabolic

Usage

advs_metabolic

Format

A data frame with 101 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
TRT01P: Planned Treatment for Period 01
TRT01A: Actual Treatment for Period 01
PARAMCD: Parameter Code
ADT: Analysis Date
ADY: Analysis Relative Day
ATPT: Analysis Timepoint
ATPTN: Analysis Timepoint (N)
AVISIT: Analysis Visit
AVISITN: Analysis Visit (N)
AVAL: Analysis Value
AVALCAT1: Analysis Value Category 1
AVALCA1N: Analysis Value Category 1 (N)
ABLFL: Baseline Record Flag
BASE: Baseline Value
CHG: Change from Baseline
PCHG: Percent Change from Baseline
BASECAT1: Baseline Category 1
BASECA1N: Baseline Category 1 (N)
CRIT1FL: Criterion 1 Evaluation Result Flag
CRIT1: Analysis Criterion 1
CRIT2FL: Criterion 2 Evaluation Result Flag
CRIT2: Analysis Criterion 2
PARAM: Parameter
PARAMN: Parameter (N)
PARCAT1: Parameter Category 1
PARCAT1N: Parameter 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
EOSDT: End of Study Date
EOSSTT: End of Study Status
FRVDT: Final Retrieval 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: 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
ASEQ: Analysis Sequence Number

Details

Contains a set of 10 unique Parameter Codes and Parameters:

PARAMCD	PARAM
BMI	Body Mass Index (kg/m2)
DIABP	Diastolic Blood Pressure (mmHg)
HEIGHT	Height (cm)
HIPCIR	Hip Circumference (cm)
PULSE	Pulse Rate (beats/min)
SYSBP	Systolic Blood Pressure (mmHg)
TEMP	Temperature (C)
WAISTHIP	Waist to Hip Ratio
WEIGHT	Weight (kg)
WSTCIR	Waist Circumference (cm)

Source

Generated from admiralmetabolic package (template ad_advs.R).

References

None

Examples

data("advs_metabolic")

Vital Signs Analysis for Pediatrics

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

Details

Contains a set of 14 unique Parameter Codes and Parameters:

PARAMCD	PARAM
BMI	Body Mass Index(kg/m^2)
BMIPCTL	BMI-for-age percentile
BMISDS	BMI-for-age z-score
HDCIRC	Head Circumference (cm)
HDCPCTL	Head Circumference-for-age percentile
HDCSDS	Head Circumference-for-age z-score
HEIGHT	Height (cm)
HGTPCTL	Height-for-age percentile
HGTSDS	Height-for-age z-score
WEIGHT	Weight (kg)
WGTAPCTL	Weight-for-age percentile
WGTASDS	Weight-for-age z-score
WGTHPCTL	Weight-for-length/height Percentile
WGTHSDS	Weight-for-length/height Z-Score

Source

Generated from admiralpeds package (template ad_advs.R).

References

None

Examples

data("advs_peds")

pharmaverseadam: ADaM Test Data for the 'Pharmaverse' Family of Packages

Description

Author(s)

See Also

Adverse Events Analysis

Description

Usage

Format

Source

References

Examples

Best Corrected Visual Acuity Analysis

Description

Usage

Format

Details

Source

References

Examples

Clinical Events Analysis for Vaccine

Description

Usage

Format

Source

References

Examples

Concomitant Medications Analysis

Description

Usage

Format

Source

References

Examples

Questionnaires Analysis for Metabolic

Description

Usage

Format

Details

Source

References

Examples

Electrocardiogram Tests Analysis

Description

Usage

Format

Details

Source

References

Examples

Exposure Analysis

Description

Usage

Format

Details

Source

References

Examples

Findings About Clinical Events Analysis

Description

Usage

Format

Details

Source

References

Examples

Immunogenicity Specimen Assessments

Description

Usage

Format

Details

Source

References

Examples

Laboratory Analysis

Description

Usage

Format

Details

Source

References