From 719421b79669f31c01c4a12aaef2dc632ccfa8c4 Mon Sep 17 00:00:00 2001 From: GitHub Actions Date: Tue, 2 Jul 2024 18:29:25 +0000 Subject: [PATCH] cli-147-473 --- news/index.html | 2 +- pkgdown.yml | 2 +- search.json | 2 +- 3 files changed, 3 insertions(+), 3 deletions(-) diff --git a/news/index.html b/news/index.html index 4dc2abf..d69d5f9 100644 --- a/news/index.html +++ b/news/index.html @@ -45,7 +45,7 @@
-

pharmaverseadam 1.0.0

+

pharmaverseadam 1.0.0

CRAN release: 2024-07-01

Documentation

  • The first stable version of pharmaverseadam!
  • diff --git a/pkgdown.yml b/pkgdown.yml index ad35ea6..7530e5b 100644 --- a/pkgdown.yml +++ b/pkgdown.yml @@ -2,7 +2,7 @@ pandoc: 3.1.11 pkgdown: 2.0.9 pkgdown_sha: ~ articles: {} -last_built: 2024-07-01T08:15Z +last_built: 2024-07-02T18:29Z urls: reference: https://pharmaverse.github.io/pharmaverseadam/reference article: https://pharmaverse.github.io/pharmaverseadam/articles diff --git a/search.json b/search.json index f90ed97..106b92a 100644 --- a/search.json +++ b/search.json @@ -1 +1 @@ -[{"path":"https://pharmaverse.github.io/pharmaverseadam/LICENSE.html","id":null,"dir":"","previous_headings":"","what":"Apache License","title":"Apache License","text":"Version 2.0, January 2004 ","code":""},{"path":[]},{"path":"https://pharmaverse.github.io/pharmaverseadam/LICENSE.html","id":"id_1-definitions","dir":"","previous_headings":"Terms and Conditions for use, reproduction, and distribution","what":"1. Definitions","title":"Apache License","text":"“License” shall mean terms conditions use, reproduction, distribution defined Sections 1 9 document. “Licensor” shall mean copyright owner entity authorized copyright owner granting License. “Legal Entity” shall mean union acting entity entities control, controlled , common control entity. purposes definition, “control” means () power, direct indirect, cause direction management entity, whether contract otherwise, (ii) ownership fifty percent (50%) outstanding shares, (iii) beneficial ownership entity. “” (“”) shall mean individual Legal Entity exercising permissions granted License. “Source” form shall mean preferred form making modifications, including limited software source code, documentation source, configuration files. “Object” form shall mean form resulting mechanical transformation translation Source form, including limited compiled object code, generated documentation, conversions media types. “Work” shall mean work authorship, whether Source Object form, made available License, indicated copyright notice included attached work (example provided Appendix ). “Derivative Works” shall mean work, whether Source Object form, based (derived ) Work editorial revisions, annotations, elaborations, modifications represent, whole, original work authorship. purposes License, Derivative Works shall include works remain separable , merely link (bind name) interfaces , Work Derivative Works thereof. “Contribution” shall mean work authorship, including original version Work modifications additions Work Derivative Works thereof, intentionally submitted Licensor inclusion Work copyright owner individual Legal Entity authorized submit behalf copyright owner. purposes definition, “submitted” means form electronic, verbal, written communication sent Licensor representatives, including limited communication electronic mailing lists, source code control systems, issue tracking systems managed , behalf , Licensor purpose discussing improving Work, excluding communication conspicuously marked otherwise designated writing copyright owner “Contribution”. “Contributor” shall mean Licensor individual Legal Entity behalf Contribution received Licensor subsequently incorporated within Work.","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/LICENSE.html","id":"id_2-grant-of-copyright-license","dir":"","previous_headings":"Terms and Conditions for use, reproduction, and distribution","what":"2. Grant of Copyright License","title":"Apache License","text":"Subject terms conditions License, Contributor hereby grants perpetual, worldwide, non-exclusive, -charge, royalty-free, irrevocable copyright license reproduce, prepare Derivative Works , publicly display, publicly perform, sublicense, distribute Work Derivative Works Source Object form.","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/LICENSE.html","id":"id_3-grant-of-patent-license","dir":"","previous_headings":"Terms and Conditions for use, reproduction, and distribution","what":"3. Grant of Patent License","title":"Apache License","text":"Subject terms conditions License, Contributor hereby grants perpetual, worldwide, non-exclusive, -charge, royalty-free, irrevocable (except stated section) patent license make, made, use, offer sell, sell, import, otherwise transfer Work, license applies patent claims licensable Contributor necessarily infringed Contribution(s) alone combination Contribution(s) Work Contribution(s) submitted. institute patent litigation entity (including cross-claim counterclaim lawsuit) alleging Work Contribution incorporated within Work constitutes direct contributory patent infringement, patent licenses granted License Work shall terminate date litigation filed.","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/LICENSE.html","id":"id_4-redistribution","dir":"","previous_headings":"Terms and Conditions for use, reproduction, and distribution","what":"4. Redistribution","title":"Apache License","text":"may reproduce distribute copies Work Derivative Works thereof medium, without modifications, Source Object form, provided meet following conditions: () must give recipients Work Derivative Works copy License; (b) must cause modified files carry prominent notices stating changed files; (c) must retain, Source form Derivative Works distribute, copyright, patent, trademark, attribution notices Source form Work, excluding notices pertain part Derivative Works; (d) Work includes “NOTICE” text file part distribution, Derivative Works distribute must include readable copy attribution notices contained within NOTICE file, excluding notices pertain part Derivative Works, least one following places: within NOTICE text file distributed part Derivative Works; within Source form documentation, provided along Derivative Works; , within display generated Derivative Works, wherever third-party notices normally appear. contents NOTICE file informational purposes modify License. may add attribution notices within Derivative Works distribute, alongside addendum NOTICE text Work, provided additional attribution notices construed modifying License. may add copyright statement modifications may provide additional different license terms conditions use, reproduction, distribution modifications, Derivative Works whole, provided use, reproduction, distribution Work otherwise complies conditions stated License.","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/LICENSE.html","id":"id_5-submission-of-contributions","dir":"","previous_headings":"Terms and Conditions for use, reproduction, and distribution","what":"5. Submission of Contributions","title":"Apache License","text":"Unless explicitly state otherwise, Contribution intentionally submitted inclusion Work Licensor shall terms conditions License, without additional terms conditions. Notwithstanding , nothing herein shall supersede modify terms separate license agreement may executed Licensor regarding Contributions.","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/LICENSE.html","id":"id_6-trademarks","dir":"","previous_headings":"Terms and Conditions for use, reproduction, and distribution","what":"6. Trademarks","title":"Apache License","text":"License grant permission use trade names, trademarks, service marks, product names Licensor, except required reasonable customary use describing origin Work reproducing content NOTICE file.","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/LICENSE.html","id":"id_7-disclaimer-of-warranty","dir":"","previous_headings":"Terms and Conditions for use, reproduction, and distribution","what":"7. Disclaimer of Warranty","title":"Apache License","text":"Unless required applicable law agreed writing, Licensor provides Work (Contributor provides Contributions) “” BASIS, WITHOUT WARRANTIES CONDITIONS KIND, either express implied, including, without limitation, warranties conditions TITLE, NON-INFRINGEMENT, MERCHANTABILITY, FITNESS PARTICULAR PURPOSE. solely responsible determining appropriateness using redistributing Work assume risks associated exercise permissions License.","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/LICENSE.html","id":"id_8-limitation-of-liability","dir":"","previous_headings":"Terms and Conditions for use, reproduction, and distribution","what":"8. Limitation of Liability","title":"Apache License","text":"event legal theory, whether tort (including negligence), contract, otherwise, unless required applicable law (deliberate grossly negligent acts) agreed writing, shall Contributor liable damages, including direct, indirect, special, incidental, consequential damages character arising result License use inability use Work (including limited damages loss goodwill, work stoppage, computer failure malfunction, commercial damages losses), even Contributor advised possibility damages.","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/LICENSE.html","id":"id_9-accepting-warranty-or-additional-liability","dir":"","previous_headings":"Terms and Conditions for use, reproduction, and distribution","what":"9. Accepting Warranty or Additional Liability","title":"Apache License","text":"redistributing Work Derivative Works thereof, may choose offer, charge fee , acceptance support, warranty, indemnity, liability obligations /rights consistent License. However, accepting obligations, may act behalf sole responsibility, behalf Contributor, agree indemnify, defend, hold Contributor harmless liability incurred , claims asserted , Contributor reason accepting warranty additional liability. END TERMS CONDITIONS","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/LICENSE.html","id":"appendix-how-to-apply-the-apache-license-to-your-work","dir":"","previous_headings":"","what":"APPENDIX: How to apply the Apache License to your work","title":"Apache License","text":"apply Apache License work, attach following boilerplate notice, fields enclosed brackets [] replaced identifying information. (Don’t include brackets!) text enclosed appropriate comment syntax file format. also recommend file class name description purpose included “printed page” copyright notice easier identification within third-party archives.","code":"Copyright 2021 F. Hoffmann-La Roche AG and GlaxoSmithKline LLC Licensed under the Apache License, Version 2.0 (the \"License\"); you may not use this file except in compliance with the License. You may obtain a copy of the License at http://www.apache.org/licenses/LICENSE-2.0 Unless required by applicable law or agreed to in writing, software distributed under the License is distributed on an \"AS IS\" BASIS, WITHOUT WARRANTIES OR CONDITIONS OF ANY KIND, either express or implied. See the License for the specific language governing permissions and limitations under the License."},{"path":"https://pharmaverse.github.io/pharmaverseadam/authors.html","id":null,"dir":"","previous_headings":"","what":"Authors","title":"Authors and Citation","text":"Edoardo Mancini. Author, maintainer. Kangjie Zhang. Author. Stefan Bundfuss. Author. Gayatri G. Author. Daphne Grassely. Author. Zelos Zhu. Author. Sadchla Mascary. Author.","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/authors.html","id":"citation","dir":"","previous_headings":"","what":"Citation","title":"Authors and Citation","text":"Mancini E, Zhang K, Bundfuss S, G G, Grassely D, Zhu Z, Mascary S (2024). pharmaverseadam: ADaM Test Data 'Pharmaverse' Family Packages. R package version 1.0.0, https://github.com/pharmaverse/pharmaverseadam/, https://pharmaverse.github.io/pharmaverseadam/.","code":"@Manual{, title = {pharmaverseadam: ADaM Test Data for the 'Pharmaverse' Family of Packages}, author = {Edoardo Mancini and Kangjie Zhang and Stefan Bundfuss and Gayatri G and Daphne Grassely and Zelos Zhu and Sadchla Mascary}, year = {2024}, note = {R package version 1.0.0, https://github.com/pharmaverse/pharmaverseadam/}, url = {https://pharmaverse.github.io/pharmaverseadam/}, }"},{"path":"https://pharmaverse.github.io/pharmaverseadam/index.html","id":"pharmaverseadam-","dir":"","previous_headings":"","what":"ADaM Test Data for the Pharmaverse Family of Packages","title":"ADaM Test Data for the Pharmaverse Family of Packages","text":"Test data (ADaM) pharmaverse family packages","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/index.html","id":"purpose","dir":"","previous_headings":"","what":"Purpose","title":"ADaM Test Data for the Pharmaverse Family of Packages","text":"provide one-stop-shop ADaM test data pharmaverse family packages.","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/index.html","id":"package-contents","dir":"","previous_headings":"","what":"Package Contents","title":"ADaM Test Data for the Pharmaverse Family of Packages","text":"ADaM contents package populated action executes admiral, admiralonco, admiralophtha admiralvaccine templates saves resulting datasets . action can triggered manually package maintainers two scenarios: Regularly, upon new releases admiral, admiralonco, admiralophtha admiralvaccine; Ad-hoc, whenever templates packages updated releases far away calendar. case, ADaM datasets created using development version templates.","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/index.html","id":"installation","dir":"","previous_headings":"","what":"Installation","title":"ADaM Test Data for the Pharmaverse Family of Packages","text":"package available CRAN can installed running install.packages(\"pharmaverseadam\"). install latest development version package directly GitHub use following code:","code":"if (!requireNamespace(\"remotes\", quietly = TRUE)) { install.packages(\"remotes\") } remotes::install_github(\"pharmaverse/pharmaverseadam\", ref = \"main\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adae.html","id":null,"dir":"Reference","previous_headings":"","what":"Adverse Events Analysis — adae","title":"Adverse Events Analysis — adae","text":"example ADAE ADaM dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adae.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Adverse Events Analysis — adae","text":"","code":"adae"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adae.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Adverse Events Analysis — adae","text":"data frame 101 columns: STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier AESEQ Sequence Number AESPID Sponsor-Defined Identifier AETERM Reported Term 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 Organ Class AEBDSYCD Body System Organ Class Code AESOC Primary System Organ Class AESOCCD Primary System Organ Class Code AESEV Severity/Intensity AESER Serious Event AEACN Action Taken Study Treatment AEREL Causality AEOUT Outcome Adverse Event AESCAN Involves Cancer AESCONG Congenital Anomaly Birth Defect AESDISAB Persist Signif Disability/Incapacity AESDTH Results Death AESHOSP Requires Prolongs Hospitalization AESLIFE Life Threatening AESOD Occurred Overdose AEDTC Date/Time Collection AESTDTC Start Date/Time Adverse Event AEENDTC End Date/Time Adverse Event AESTDY Study Day Start Adverse Event AEENDY Study Day End Adverse Event TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment DTHDT Date Death EOSDT End 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 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 Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRT01P Planned Treatment Period 01 TRT01A Actual Treatment Period 01 TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adae.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Adverse Events Analysis — adae","text":"Generated admiral package (template ad_adae.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adae.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Adverse Events Analysis — adae","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adae.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Adverse Events Analysis — adae","text":"","code":"data(\"adae\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adbcva_ophtha.html","id":null,"dir":"Reference","previous_headings":"","what":"Best Corrected Visual Acuity Analysis — adbcva_ophtha","title":"Best Corrected Visual Acuity Analysis — adbcva_ophtha","text":"example ADBCVA ADaM dataset Ophthalmology studies","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adbcva_ophtha.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Best Corrected Visual Acuity Analysis — adbcva_ophtha","text":"","code":"adbcva_ophtha"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adbcva_ophtha.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Best Corrected Visual Acuity Analysis — adbcva_ophtha","text":"data frame 116 columns: STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier OESEQ Sequence Number OECAT Category Ophthalmic Test Exam OESCAT Subcategory Ophthalmic Test Exam OEDTC Date/Time Collection VISIT Visit Name VISITNUM Visit Number VISITDY Planned Study Day Visit OESTRESN Numeric Result/Finding Standard Units OESTRESC Character Result/Finding Std Format OEORRES Result Finding Original Units OETEST Name Ophthalmic Test Exam OETESTCD Short Name Ophthalmic Test Exam OETSTDTL Ophthalmic Test Exam Detail OELAT Laterality OELOC Location Used Measurement OEDY Study Day Visit/Collection/Exam OEMETHOD Method Test Examination OEORRESU Original Units OESTRESU Standard Units OESTAT Completion Status OETPT Planned Time Point Name OETPTNUM Planned Time Point Number TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment TRT01A Actual Treatment Period 01 TRT01P Planned Treatment 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 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 Baseline PCHG Percent Change Baseline ASEQ Analysis Sequence Number SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country/Region DMDTC Date/Time Collection DMDY Study Day Collection TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSDT End Study Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHDT Date Death DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days 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","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adbcva_ophtha.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Best Corrected Visual Acuity Analysis — adbcva_ophtha","text":"Generated admiralophtha package (template ad_adbcva.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adbcva_ophtha.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Best Corrected Visual Acuity Analysis — adbcva_ophtha","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adbcva_ophtha.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Best Corrected Visual Acuity Analysis — adbcva_ophtha","text":"","code":"data(\"adbcva_ophtha\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adce_vaccine.html","id":null,"dir":"Reference","previous_headings":"","what":"Clinical Events Analysis for Vaccine — adce_vaccine","title":"Clinical Events Analysis for Vaccine — adce_vaccine","text":"example ADCE dataset Vaccine studies","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adce_vaccine.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Clinical Events Analysis for Vaccine — adce_vaccine","text":"","code":"adce_vaccine"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adce_vaccine.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Clinical Events Analysis for Vaccine — adce_vaccine","text":"data frame 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 Clinical Event CEDECOD Dictionary-Derived Term CELAT Laterality CELOC Location Event CECAT Category Clinical Event CESCAT Subcategory Clinical Event CEPRESP Clinical Event Pre-specified CEOCCUR Clinical Event Occurrence CESEV Severity/Intensity CEREL Causality CEOUT Outcome Event EPOCH Epoch CEDTC Date/Time Event Collection CESTDTC Start Date/Time Clinical Event CEENDTC End Date/Time Clinical Event CEDUR Duration Clinical Event CETPT Planned Time Point Name CETPTNUM Planned Time Point Number CETPTREF Time Point Reference CERFTDTC Date/Time Reference Time Point CEEVINTX Evaluation Interval Text CESTAT Completion Status CEREASND Reason Clinical Event Collected TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure 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 Period 01 TRT01P Planned Treatment Period 01 AGE Age AGEU Age Units SEX Sex RACE Race COUNTRY Country ETHNIC Ethnicity SITEID Study Site Identifier SUBJID Subject Identifier Study","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adce_vaccine.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Clinical Events Analysis for Vaccine — adce_vaccine","text":"Generated admiralvaccine package (template ad_adce.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adce_vaccine.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Clinical Events Analysis for Vaccine — adce_vaccine","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adce_vaccine.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Clinical Events Analysis for Vaccine — adce_vaccine","text":"","code":"data(\"adce_vaccine\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adcm.html","id":null,"dir":"Reference","previous_headings":"","what":"Concomitant Medications Analysis — adcm","title":"Concomitant Medications Analysis — adcm","text":"example ADCM ADaM dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adcm.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Concomitant Medications Analysis — adcm","text":"","code":"adcm"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adcm.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Concomitant Medications Analysis — adcm","text":"data frame 90 columns: STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier CMSEQ Sequence Number CMSPID Sponsor-Defined Identifier CMTRT Reported Name Drug, Med, Therapy CMDECOD Standardized Medication Name CMINDC Indication CMCLAS Medication Class CMDOSE Dose per Administration CMDOSU Dose Units CMDOSFRQ Dosing Frequency per Interval CMROUTE Route Administration VISITNUM Visit Number VISIT Visit Name VISITDY Planned Study Day Visit CMDTC Date/Time Collection CMSTDTC Start Date/Time Medication CMENDTC End Date/Time Medication CMSTDY Study Day Start Medication CMENDY Study Day End Medication TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment DTHDT Date Death EOSDT End Study Date TRT01P Planned Treatment Period 01 TRT01A Actual Treatment 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 Treatment Record Flag PREFL Pre-treatment Flag FUPFL Follow-Flag ANL01FL Analysis Flag 01 AOCCPFL 1st Occurrence Preferred Term Flag APHASE Phase APHASEN Description Phase N TRTP Planned Treatment TRTA Actual Treatment SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Treatment End Datetime Imput Flag TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adcm.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Concomitant Medications Analysis — adcm","text":"Generated admiral package (template ad_adcm.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adcm.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Concomitant Medications Analysis — adcm","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adcm.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Concomitant Medications Analysis — adcm","text":"","code":"data(\"adcm\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adeg.html","id":null,"dir":"Reference","previous_headings":"","what":"Electrocardiogram Tests Analysis — adeg","title":"Electrocardiogram Tests Analysis — adeg","text":"example ADEG ADaM dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adeg.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Electrocardiogram Tests Analysis — adeg","text":"","code":"adeg"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adeg.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Electrocardiogram Tests Analysis — adeg","text":"data frame 105 columns: STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier EGSEQ Sequence Number EGTESTCD ECG Test Examination Short Name EGTEST ECG Test Examination Name EGORRES Result Finding Original Units EGORRESU Original Units EGSTRESC Character Result/Finding Std Format EGSTRESN Numeric Result/Finding Standard Units EGSTRESU Standard Units EGSTAT Completion Status EGLOC Lead Location Used Measurement EGBLFL Baseline Flag VISITNUM Visit Number VISIT Visit Name VISITDY Planned Study Day Visit EGDTC Date/Time ECG EGDY Study Day ECG EGTPT Planned Time Point Name EGTPTNUM Planned Time Point Number EGELTM Planned Elapsed Time Time Point Ref EGTPTREF Time Point Reference temp undocumented field TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment TRT01A Actual Treatment Period 01 TRT01P Planned Treatment 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 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 Baseline PCHG Percent Change Baseline ANL01FL Analysis Flag 01 TRTP Planned Treatment TRTA Actual Treatment ASEQ Analysis Sequence Number AVALCA1N Analysis Value Category 1 (N) AVALCAT1 Analysis Value Category 1 CHGCAT1N Change Baseline Category 1 (N) CHGCAT1 Change Baseline Category 1 PARAM Parameter PARAMN Parameter (N) SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSDT End Study Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHDT Date Death DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adeg.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Electrocardiogram Tests Analysis — adeg","text":"Generated admiral package (template ad_adeg.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adeg.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Electrocardiogram Tests Analysis — adeg","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adeg.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Electrocardiogram Tests Analysis — adeg","text":"","code":"data(\"adeg\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adex.html","id":null,"dir":"Reference","previous_headings":"","what":"Exposure Analysis — adex","title":"Exposure Analysis — adex","text":"example ADEX ADaM dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adex.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Exposure Analysis — adex","text":"","code":"adex"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adex.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Exposure Analysis — adex","text":"data frame 88 columns: STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier EXSEQ Sequence Number EXTRT Name Treatment EXDOSE Dose EXDOSU Dose Units EXDOSFRM Dose Form EXDOSFRQ Dosing Frequency per Interval EXROUTE Route Administration VISITNUM Visit Number VISIT Visit Name VISITDY Planned Study Day Visit EXSTDTC Start Date/Time Treatment EXENDTC End Date/Time Treatment EXSTDY Study Day Start Treatment EXENDY Study Day End Treatment EXADJ Reason Dose Adjustment EXPLDOS Planned Dose TRTSDT Date First Exposure Treatment TRTSDTM Datetime First Exposure Treatment TRTEDTM Datetime Last Exposure 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 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 Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRT01P Planned Treatment Period 01 TRT01A Actual Treatment Period 01 TRTSTMF Time First Exposure Imput. Flag TRTETMF Time Last Exposure Imput. Flag TRTEDT Date Last Exposure Treatment TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSDT End Study Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHDT Date Death DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adex.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Exposure Analysis — adex","text":"Generated admiral package (template ad_adex.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adex.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Exposure Analysis — adex","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adex.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Exposure Analysis — adex","text":"","code":"data(\"adex\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adface_vaccine.html","id":null,"dir":"Reference","previous_headings":"","what":"Findings About Clinical Events Analysis — adface_vaccine","title":"Findings About Clinical Events Analysis — adface_vaccine","text":"example ADFACE Vaccine studies","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adface_vaccine.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Findings About Clinical Events Analysis — adface_vaccine","text":"","code":"adface_vaccine"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adface_vaccine.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Findings About Clinical Events Analysis — adface_vaccine","text":"data frame 60 columns: STUDYID Study Identifier USUBJID Unique Subject Identifier SUBJID Subject Identifier Study SITEID Study Site Identifier AGE Age AGEU Age Units SEX Sex RACE Race SAFFL Safety Population Flag ARM Description Planned Arm ARMCD Planned Arm Code ACTARM Description Actual Arm ACTARMCD Actual Arm Code TRTSDT Date First Exposure Treatment TRTSDTM Datetime First Exposure Treatment TRTEDT Date Last Exposure Treatment TRTEDTM Datetime Last Exposure Treatment FATEST Findings Test Name FALNKID Link ID FALNKGRP Link Group ID FATESTCD Findings Test Short Name PARAMCD Parameter Code PARAM Parameter PARAMN Parameter (N) FAOBJ Object Observation PARCAT1 Parameter Category 1 PARCAT2 Parameter Category 2 AVALC Analysis Value (C) AVAL Analysis Value FASTAT Completion Status FAREASND Reason 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 Treatment EXSTDTC Start Date/Time Treatment EXENDTC End Date/Time Treatment TRTA Actual Treatment TRTP Planned Treatment APERIOD Period APERSDT Period Start Date APEREDT Period End Date FAORRES Result Finding Original Units TRT01P Planned Treatment Period 01 TRT02P Planned Treatment Period 02 TRT01A Actual Treatment Period 01 TRT02A Actual Treatment 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","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adface_vaccine.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Findings About Clinical Events Analysis — adface_vaccine","text":"Generated admiralvaccine package (template ad_adface.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adface_vaccine.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Findings About Clinical Events Analysis — adface_vaccine","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adface_vaccine.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Findings About Clinical Events Analysis — adface_vaccine","text":"","code":"data(\"adface_vaccine\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adis_vaccine.html","id":null,"dir":"Reference","previous_headings":"","what":"Immunogenicity Specimen Assessments — adis_vaccine","title":"Immunogenicity Specimen Assessments — adis_vaccine","text":"example ADIS dataset Vaccine studies","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adis_vaccine.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Immunogenicity Specimen Assessments — adis_vaccine","text":"","code":"adis_vaccine"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adis_vaccine.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Immunogenicity Specimen Assessments — adis_vaccine","text":"data frame 102 columns: STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier ISSEQ Sequence Number ISTESTCD Immunogenicity Test/Exam Short Name ISTEST Immunogenicity Test Examination Name ISCAT Category Immunogenicity Test ISORRES Results Findings Original Units ISORRESU Original Units ISSTRESC Character Result/Finding Std Format ISSTRESN Numeric Results/Findings Std. Units ISSTRESU Standard Units ISSTAT Completion Status ISREASND Reason Done ISNAM Vendor Name ISSPEC Specimen Type ISMETHOD Method Test Examination ISBLFL Baseline Flag ISLLOQ Lower Limit Quantitation VISITNUM Visit Number EPOCH Epoch ISDTC Date/Time Collection ISDY Study Day Visit/Collection/Exam ISULOQ Upper Limit Quantitation LOD Limit 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 Baseline R2BASE Ratio 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 Study RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time Death DTHFL Subject Death Flag SITEID Study Site Identifier INVID Investigator Identifier INVNAM Investigator Name BRTHDTC Date/Time Birth AGE Age AGEU Age Units SEX Sex RACE Race ETHNIC Ethnicity ARMCD Planned Arm Code ARM Description Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRT01P Planned Treatment Period 01 TRT02P Planned Treatment Period 02 TRT01A Actual Treatment Period 01 TRT02A Actual Treatment Period 02 TRTSDTM Datetime First Exposure Treatment TRTEDTM Datetime Last Exposure Treatment TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure 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","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adis_vaccine.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Immunogenicity Specimen Assessments — adis_vaccine","text":"Generated admiralvaccine package (template ad_adis.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adis_vaccine.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Immunogenicity Specimen Assessments — adis_vaccine","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adis_vaccine.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Immunogenicity Specimen Assessments — adis_vaccine","text":"","code":"data(\"adis_vaccine\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlb.html","id":null,"dir":"Reference","previous_headings":"","what":"Laboratory Analysis — adlb","title":"Laboratory Analysis — adlb","text":"example ADLB ADaM dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlb.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Laboratory Analysis — adlb","text":"","code":"adlb"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlb.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Laboratory Analysis — adlb","text":"data frame 111 columns: STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier LBSEQ Sequence Number LBTESTCD Lab Test Examination Short Name LBTEST Lab Test Examination Name LBCAT Category Lab Test LBORRES Result Finding Original Units LBORRESU Original Units LBORNRLO Reference Range Lower Limit Orig Unit LBORNRHI Reference Range Upper Limit Orig Unit LBSTRESC Character Result/Finding Std Format LBSTRESN Numeric Result/Finding 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 Visit LBDTC Date/Time Specimen Collection LBDY Study Day Specimen Collection TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment TRT01A Actual Treatment Period 01 TRT01P Planned Treatment 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 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 Baseline PCHG Percent Change 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 Baseline R2ANRLO Ratio Analysis Val compared ANRLO R2ANRHI Ratio Analysis Val compared ANRHI SHIFT1 Shift Baseline Analysis Value SHIFT2 Shift Baseline Overall Grade ANL01FL Analysis Flag 01 LVOTFL Last Value Treatment Record Flag TRTP Planned Treatment TRTA Actual Treatment ASEQ Analysis Sequence Number SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSDT End Study Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHDT Date Death DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlb.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Laboratory Analysis — adlb","text":"Generated admiral package (template ad_adlb.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlb.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Laboratory Analysis — adlb","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlb.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Laboratory Analysis — adlb","text":"","code":"data(\"adlb\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlbhy.html","id":null,"dir":"Reference","previous_headings":"","what":"Analysis of Lab Hy's Law — adlbhy","title":"Analysis of Lab Hy's Law — adlbhy","text":"template ADLBHY dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlbhy.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Analysis of Lab Hy's Law — adlbhy","text":"","code":"adlbhy"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlbhy.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Analysis of Lab Hy's Law — adlbhy","text":"data frame 14 columns: STUDYID Study Identifier USUBJID Unique Subject Identifier TRT01A Actual Treatment 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","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlbhy.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Analysis of Lab Hy's Law — adlbhy","text":"Generated admiral package (template ad_adlbhy.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlbhy.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Analysis of Lab Hy's Law — adlbhy","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlbhy.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Analysis of Lab Hy's Law — adlbhy","text":"","code":"data(\"adlbhy\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/admh.html","id":null,"dir":"Reference","previous_headings":"","what":"Medical History Analysis — admh","title":"Medical History Analysis — admh","text":"template ADMH ADaM dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/admh.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Medical History Analysis — admh","text":"","code":"admh"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/admh.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Medical History Analysis — admh","text":"data frame 110 columns: STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier MHSEQ Sequence Number MHSPID Sponsor-Defined Identifier MHTERM Reported Term Medical History MHLLT Lowest Level Term MHDECOD Dictionary-Derived Term MHHLT High Level Term MHHLGT High Level Group Term MHCAT Category Medical History MHBODSYS Body System Organ Class MHSEV Severity/Intensity VISITNUM Visit Number VISIT Visit Name VISITDY Planned Study Day Visit MHDTC Date/Time History Collection MHSTDTC Start Date/Time Medical History Event MHDY Study Day History Collection MHENDTC End Date/Time Medical History Event MHPRESP Medical History Event Pre-Specified MHOCCUR Medical History Occurrence MHSTRTPT Start Relative Reference Time Point MHENRTPT End Relative Reference Time Point MHSTTPT Start Reference Time Point MHENTPT End Reference Time Point MHENRF End Relative Reference Period MHSTAT Completion Status TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment TRT01A Actual Treatment Period 01 TRT01P Planned Treatment Period 01 DTHDT Date Death EOSDT End 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 Med Hx (past current) AOCCFL 1st Occurrence within Subject Flag AOCCSFL 1st Occurrence SOC Flag AOCCPFL 1st Occurrence Preferred Term Flag AOCPFL 1st Occur w/Trt Prd FL AOCPSFL 1st Occur SOC w/Trt Prd FL AOCPPFL 1st Occur PT w/Trt Prd FL ANL01FL Analysis Flag 01 TRTP Planned Treatment TRTA Actual Treatment APHASE Phase APHASEN Description Phase N MHTERMN Medical History Term (N) SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Treatment End Datetime Imput Flag TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/admh.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Medical History Analysis — admh","text":"Generated admiral package (template ad_admh.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/admh.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Medical History Analysis — admh","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/admh.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Medical History Analysis — admh","text":"","code":"data(\"admh\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adoe_ophtha.html","id":null,"dir":"Reference","previous_headings":"","what":"Exam Analysis for Ophthalmology — adoe_ophtha","title":"Exam Analysis for Ophthalmology — adoe_ophtha","text":"example ADOE dataset Ophthalmology studies","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adoe_ophtha.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Exam Analysis for Ophthalmology — adoe_ophtha","text":"","code":"adoe_ophtha"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adoe_ophtha.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Exam Analysis for Ophthalmology — adoe_ophtha","text":"data frame 98 columns: STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier OESEQ Sequence Number OECAT Category Ophthalmic Test Exam OESCAT Subcategory Ophthalmic Test Exam OEDTC Date/Time Collection VISIT Visit Name VISITNUM Visit Number VISITDY Planned Study Day Visit OESTRESN Numeric Result/Finding Standard Units OESTRESC Character Result/Finding Std Format OEORRES Result Finding Original Units OETEST Name Ophthalmic Test Exam OETESTCD Short Name Ophthalmic Test Exam OETSTDTL Ophthalmic Test Exam Detail OELAT Laterality OELOC Location Used Measurement OEDY Study Day Visit/Collection/Exam OEMETHOD Method Test Examination OEORRESU Original Units OESTRESU Standard Units OESTAT Completion Status OETPT Planned Time Point Name OETPTNUM Planned Time Point Number TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment TRT01A Actual Treatment Period 01 TRT01P Planned Treatment 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 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 Baseline PCHG Percent Change Baseline ASEQ Analysis Sequence Number SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSDT End Study Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHDT Date Death DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adoe_ophtha.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Exam Analysis for Ophthalmology — adoe_ophtha","text":"Generated admiralophtha package (template ad_adoe.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adoe_ophtha.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Exam Analysis for Ophthalmology — adoe_ophtha","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adoe_ophtha.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Exam Analysis for Ophthalmology — adoe_ophtha","text":"","code":"data(\"adoe_ophtha\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpc.html","id":null,"dir":"Reference","previous_headings":"","what":"Pharmacokinetic Concentrations — adpc","title":"Pharmacokinetic Concentrations — adpc","text":"example ADPC dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpc.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Pharmacokinetic Concentrations — adpc","text":"","code":"adpc"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpc.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Pharmacokinetic Concentrations — adpc","text":"data frame 123 columns: STUDYID Study Identifier USUBJID Unique Subject Identifier NFRLT Nom. Rel. Time Analyte First Dose PCTESTCD Pharmacokinetic Test Short Name PCTEST Pharmacokinetic Test Name PCORRES Result Finding Original Units PCORRESU Original Units PCSTRESC Character Result/Finding Std Format PCSTRESN Numeric Result/Finding Standard Units PCSTRESU Standard Units PCNAM Vendor Name PCSPEC Specimen Material Type PCLLOQ Lower Limit Quantitation VISIT Visit Name VISITNUM Visit Number PCDTC Date/Time Specimen Collection PCDY Actual Study Day Specimen Collection PCTPT Planned Time Point Name PCTPTNUM Planned Time Point Number TRTSDT Date First Exposure Treatment TRTSDTM Datetime First Exposure Treatment TRT01P Planned Treatment Period 01 TRT01A Actual Treatment Period 01 ADTM Analysis Datetime ATMF Analysis Time Imputation Flag ADT Analysis Date ATM Analysis Time ADY Analysis Relative Day FANLDTM First Datetime Dose 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 Analyte First Dose ARRLT Actual Rel. Time Ref. Dose PCRFTDTM Reference Datetime Dose Analyte FANLDT First Date Dose Analyte FANLTM First Time Dose Analyte PCRFTDT Reference Date Dose Analyte PCRFTTM Reference Time Dose Analyte NRRLT Nominal Rel. Time 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 First Dose Unit RRLTU Rel. Time Ref. Dose Unit PARAMCD Parameter Code ALLOQ Analysis Lower Limit 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 Ref. Dose ANL01FL Analysis Flag 01 ANL02FL Analysis Flag 02 BASE Baseline Value CHG Change Baseline ASEQ Analysis Sequence Number PARAM Parameter PARAMN Parameter (N) HTBL Numeric Result/Finding Standard Units HTBLU Standard Units WTBL Numeric Result/Finding Standard Units WTBLU Standard Units BMIBL Baseline Body Mass Index (kg/m2) BMIBLU BMI Baseline (Unit) SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTEDT Date Last Exposure Treatment TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSDT End Study Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHDT Date Death DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL 30 Group DTHA30FL 30 Group DTHB30FL 30 plus 30 days Group","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpc.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Pharmacokinetic Concentrations — adpc","text":"Generated admiral package (template ad_adpc.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpc.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Pharmacokinetic Concentrations — adpc","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpc.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Pharmacokinetic Concentrations — adpc","text":"","code":"data(\"adpc\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpp.html","id":null,"dir":"Reference","previous_headings":"","what":"Pharmacokinetic Parameters — adpp","title":"Pharmacokinetic Parameters — adpp","text":"example ADPP ADaM dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpp.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Pharmacokinetic Parameters — adpp","text":"","code":"adpp"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpp.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Pharmacokinetic Parameters — adpp","text":"data frame 75 columns: STUDYID Study Identifier USUBJID Unique Subject Identifier PPTESTCD Parameter Short Name PPTEST Parameter Name PPCAT Parameter Category PPORRES Result Finding Original Units PPORRESU Original Units PPSTRESU Standard Units PPSPEC Specimen Material Type PPRFDTC Date/Time Reference Point TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment DTHDT Date Death EOSDT End Study Date TRT01P Planned Treatment Period 01 TRT01A Actual Treatment Period 01 ADT Analysis Date ADY Analysis Relative Day PARAMCD Parameter Code PARCAT1 Parameter Category AVAL Numeric Result/Finding 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 AVALCA1N Analysis Value Category 1 (N) AVALCAT1 Analysis Value Category 1 SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpp.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Pharmacokinetic Parameters — adpp","text":"Generated admiral package (template ad_adpp.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpp.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Pharmacokinetic Parameters — adpp","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpp.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Pharmacokinetic Parameters — adpp","text":"","code":"data(\"adpp\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adppk.html","id":null,"dir":"Reference","previous_headings":"","what":"Population Pharmacokinetic — adppk","title":"Population Pharmacokinetic — adppk","text":"template ADPPK ADaM dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adppk.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Population Pharmacokinetic — adppk","text":"","code":"adppk"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adppk.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Population Pharmacokinetic — adppk","text":"data frame 61 columns: STUDYID Study Identifier USUBJID Unique Subject Identifier EVID Event ID NFRLT Nom. Rel. Time Analyte First Dose AFRLT Act. Rel. Time Analyte First Dose APRLT Actual Rel Time Previous Dose NPRLT Nominal Rel Time Previous Dose DOSEA Actual Treatment Dose DOSEP Planned Treatment Dose PARAMCD Parameter Code ALLOQ Analysis Lower Limit Quantitation CMT Compartment BLQFL Lower Limit Quant Flag BLQFN Lower Limit Quant Flag (N) AMT Actual Amount 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 Study SUBJIDN Subject Identifier Study (N) AGE Age SEX Sex SEXN Sex (N) COHORT Cohort Subject Enrolled COHORTC Description Planned Arm ROUTE Route Administration ROUTEN Route 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 Standard Units WTBL Numeric Result/Finding Standard Units ALTBL Numeric Result/Finding Standard Units ASTBL Numeric Result/Finding Standard Units TBILBL Numeric Result/Finding Standard Units CREATBL Numeric Result/Finding Standard Units BMIBL Baseline Body Mass Index (kg/m2) BSABL Numeric Result/Finding Standard Units CRCLBL Baseline Creatinine Clearance EGFRBL Age RECSEQ Record Sequence","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adppk.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Population Pharmacokinetic — adppk","text":"Generated admiral package (template ad_adppk.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adppk.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Population Pharmacokinetic — adppk","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adppk.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Population Pharmacokinetic — adppk","text":"","code":"data(\"adppk\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adrs_onco.html","id":null,"dir":"Reference","previous_headings":"","what":"Tumor Response Analysis — adrs_onco","title":"Tumor Response Analysis — adrs_onco","text":"example ADRS dataset Oncology studies","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adrs_onco.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Tumor Response Analysis — adrs_onco","text":"","code":"adrs_onco"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adrs_onco.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Tumor Response Analysis — adrs_onco","text":"data frame 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 Finding Original Units RSSTRESC Character Result/Finding Std Format RSEVAL Evaluator RSEVALID Evaluator Identifier RSACPTFL Accepted Record Flag RSDTC Date/Time Assessment RSSEQ Sequence Number RANDDT Date 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 Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRT01P Planned Treatment Period 01 TRT01A Actual Treatment Period 01 TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSDT End Study Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date DTHDT Date Death DTHDTF Date Death Imputation Flag DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death DTHCAUS Cause Death DTHDOM Domain Date Death Collection DTHCGR1 Cause 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 Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adrs_onco.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Tumor Response Analysis — adrs_onco","text":"Generated admiralonco package (template ad_adrs.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adrs_onco.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Tumor Response Analysis — adrs_onco","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adrs_onco.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Tumor Response Analysis — adrs_onco","text":"","code":"data(\"adrs_onco\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl.html","id":null,"dir":"Reference","previous_headings":"","what":"Subject Level Analysis — adsl","title":"Subject Level Analysis — adsl","text":"example ADSL ADaM dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Subject Level Analysis — adsl","text":"","code":"adsl"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Subject Level Analysis — adsl","text":"data frame 54 columns: STUDYID Study Identifier USUBJID Unique Subject Identifier SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRT01P Planned Treatment Period 01 TRT01A Actual Treatment Period 01 TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSDT End Study Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHDT Date Death DTHDTF Date Death Imputation Flag DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose 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 Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Subject Level Analysis — adsl","text":"Generated admiral package (template ad_adsl.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Subject Level Analysis — adsl","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Subject Level Analysis — adsl","text":"","code":"data(\"adsl\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl_vaccine.html","id":null,"dir":"Reference","previous_headings":"","what":"Subject Level Analysis for Vaccine — adsl_vaccine","title":"Subject Level Analysis for Vaccine — adsl_vaccine","text":"example ADSL ADaM dataset Vaccine studies","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl_vaccine.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Subject Level Analysis for Vaccine — adsl_vaccine","text":"","code":"adsl_vaccine"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl_vaccine.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Subject Level Analysis for Vaccine — adsl_vaccine","text":"data frame 46 columns: STUDYID Study Identifier USUBJID Unique Subject Identifier SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time Death DTHFL Subject Death Flag SITEID Study Site Identifier INVID Investigator Identifier INVNAM Investigator Name BRTHDTC Date/Time Birth AGE Age AGEU Age Units SEX Sex RACE Race ETHNIC Ethnicity ARMCD Planned Arm Code ARM Description Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country/Region DMDTC Date/Time Collection DMDY Study Day Collection TRT01P Planned Treatment Period 01 TRT02P Planned Treatment Period 02 TRT01A Actual Treatment Period 01 TRT02A Actual Treatment Period 02 TRTSDTM Datetime First Exposure Treatment TRTEDTM Datetime Last Exposure Treatment TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure 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","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl_vaccine.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Subject Level Analysis for Vaccine — adsl_vaccine","text":"Generated admiralvaccine package (template ad_adsl.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl_vaccine.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Subject Level Analysis for Vaccine — adsl_vaccine","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl_vaccine.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Subject Level Analysis for Vaccine — adsl_vaccine","text":"","code":"data(\"adsl_vaccine\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtr_onco.html","id":null,"dir":"Reference","previous_headings":"","what":"Tumor Results Analysis for Oncology — adtr_onco","title":"Tumor Results Analysis for Oncology — adtr_onco","text":"example ADTR ADaM dataset Oncology studies","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtr_onco.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Tumor Results Analysis for Oncology — adtr_onco","text":"","code":"adtr_onco"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtr_onco.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Tumor Results Analysis for Oncology — adtr_onco","text":"data frame 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 Finding Original Units TRORRESU Original Units TRSTRESC Character Result/Finding Std Format TRSTRESN Numeric Result/Finding Standard Units TRSTRESU Standard Units VISITNUM Visit Number VISIT Visit Name TREVAL Evaluator TREVALID Evaluator Identifier TRACPTFL Accepted Record Flag TRDTC Date/Time Tumor/Lesion Measurement TRSEQ Sequence Number RANDDT Date Randomization TULOC Location 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 Baseline PCHG Percent Change Baseline CHGNAD Change NADIR PCHGNAD Percent Change 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 Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRT01P Planned Treatment Period 01 TRT01A Actual Treatment Period 01 TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSDT End Study Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date DTHDT Date Death DTHDTF Date Death Imputation Flag DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death DTHCAUS Cause Death DTHDOM Domain Date Death Collection DTHCGR1 Cause 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 Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtr_onco.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Tumor Results Analysis for Oncology — adtr_onco","text":"Generated admiralonco package (template ad_adtr.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtr_onco.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Tumor Results Analysis for Oncology — adtr_onco","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtr_onco.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Tumor Results Analysis for Oncology — adtr_onco","text":"","code":"data(\"adtr_onco\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtte_onco.html","id":null,"dir":"Reference","previous_headings":"","what":"Time to Event Analysis for Oncology — adtte_onco","title":"Time to Event Analysis for Oncology — adtte_onco","text":"example ADTTE ADaM dataset Oncology studies","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtte_onco.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Time to Event Analysis for Oncology — adtte_onco","text":"","code":"adtte_onco"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtte_onco.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Time to Event Analysis for Oncology — adtte_onco","text":"data frame 20 columns: STUDYID Study Identifier USUBJID Unique Subject Identifier ADT Analysis Date EVNTDESC Event Censoring Description SRCDOM Source Data SRCVAR Source Variable SRCSEQ Source Sequence Number CNSR Censor CNSDTDSC Censor Date Description STARTDT Time--Event Origin Date Subject PARAMCD Parameter Code PARAM Parameter AVAL Analysis Value ASEQ Analysis Sequence Number ARMCD Planned Arm Code ARM Description Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm AGE Age SEX Sex","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtte_onco.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Time to Event Analysis for Oncology — adtte_onco","text":"Generated admiralonco package (template ad_adtte.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtte_onco.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Time to Event Analysis for Oncology — adtte_onco","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtte_onco.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Time to Event Analysis for Oncology — adtte_onco","text":"","code":"data(\"adtte_onco\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advfq_ophtha.html","id":null,"dir":"Reference","previous_headings":"","what":"Visual Function Questionnaire Analysis — advfq_ophtha","title":"Visual Function Questionnaire Analysis — advfq_ophtha","text":"example ADVFQ ADaM dataset Ophthalmology studies","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advfq_ophtha.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Visual Function Questionnaire Analysis — advfq_ophtha","text":"","code":"advfq_ophtha"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advfq_ophtha.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Visual Function Questionnaire Analysis — advfq_ophtha","text":"data frame 85 columns: STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier QSSEQ Sequence Number QSTESTCD Question Short Name QSTEST Question Name QSCAT Category Question QSSCAT Subcategory Question QSORRES Finding Original Units QSORRESU Original Units QSSTRESC Character Result/Finding Std Format QSSTRESN Numeric Finding Standard Units QSSTRESU Standard Units QSBLFL Baseline Flag QSDRVFL Derived Flag VISITNUM Visit Number VISIT Visit Name VISITDY Planned Study Day Visit QSDTC Date/Time Finding QSDY Study Day Finding TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment TRT01A Actual Treatment Period 01 TRT01P Planned Treatment 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 Treatment Record Flag ABLFL Baseline Record Flag BASE Baseline Value CHG Change Baseline PCHG Percent Change Baseline ANL01FL Analysis Flag 01 ASEQ Analysis Sequence Number PARAM Parameter PARCAT1 Parameter Category 1 PARCAT2 Parameter Category 2 SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSDT End Study Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHDT Date Death DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advfq_ophtha.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Visual Function Questionnaire Analysis — advfq_ophtha","text":"Generated admiralophtha package (template ad_advfq.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advfq_ophtha.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Visual Function Questionnaire Analysis — advfq_ophtha","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advfq_ophtha.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Visual Function Questionnaire Analysis — advfq_ophtha","text":"","code":"data(\"advfq_ophtha\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advs.html","id":null,"dir":"Reference","previous_headings":"","what":"Vital Signs Analysis — advs","title":"Vital Signs Analysis — advs","text":"example ADVS ADaM dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advs.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Vital Signs Analysis — advs","text":"","code":"advs"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advs.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Vital Signs Analysis — advs","text":"data frame 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 Subject VSORRES Result Finding Original Units VSORRESU Original Units VSSTRESC Character Result/Finding Std Format VSSTRESN Numeric Result/Finding Standard Units VSSTRESU Standard Units VSSTAT Completion Status VSLOC Location Vital Signs Measurement VSBLFL Baseline Flag VISITNUM Visit Number VISIT Visit Name VISITDY Planned Study Day Visit VSDTC Date/Time Measurements VSDY Study Day Vital Signs VSTPT Planned Time Point Name VSTPTNUM Planned Time Point Number VSELTM Planned Elapsed Time Time Point Ref VSTPTREF Time Point Reference TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment TRT01A Actual Treatment Period 01 TRT01P Planned Treatment 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 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 Baseline PCHG Percent Change Baseline ANL01FL Analysis Flag 01 TRTP Planned Treatment TRTA Actual Treatment ASEQ Analysis Sequence Number AVALCA1N Analysis Value Category 1 (N) AVALCAT1 Analysis Value Category 1 PARAM Parameter PARAMN Parameter (N) SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSDT End Study Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHDT Date Death DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advs.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Vital Signs Analysis — advs","text":"Generated admiral package (template ad_advs.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advs.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Vital Signs Analysis — advs","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advs.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Vital Signs Analysis — advs","text":"","code":"data(\"advs\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/pharmaverseadam-package.html","id":null,"dir":"Reference","previous_headings":"","what":"pharmaverseadam: ADaM Test Data for the 'Pharmaverse' Family of Packages — pharmaverseadam-package","title":"pharmaverseadam: ADaM Test Data for the 'Pharmaverse' Family of Packages — pharmaverseadam-package","text":"set Analysis Data Model (ADaM) datasets constructed using Study Data Tabulation Model (SDTM) datasets contained 'pharmaversesdtm' package template scripts 'admiral' family packages. ADaM dataset specifications described : CDISC Analysis Data Model Team (2021) https://www.cdisc.org/system/files/members/standard/foundational/ADaMIG_v1.3.pdf.","code":""},{"path":[]},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/pharmaverseadam-package.html","id":"author","dir":"Reference","previous_headings":"","what":"Author","title":"pharmaverseadam: ADaM Test Data for the 'Pharmaverse' Family of Packages — pharmaverseadam-package","text":"Maintainer: Edoardo Mancini edoardo.mancini@roche.com Authors: Kangjie Zhang Stefan Bundfuss Gayatri G Daphne Grassely Zelos Zhu Sadchla Mascary","code":""},{"path":[]},{"path":"https://pharmaverse.github.io/pharmaverseadam/news/index.html","id":"documentation-1-0-0","dir":"Changelog","previous_headings":"","what":"Documentation","title":"pharmaverseadam 1.0.0","text":"first stable version pharmaverseadam! Dataset labels updated align ADaM IG (#64) Refreshed pharmaverseadam datasets using admiral 1.1.1, admiralophtha 1.1.0, admiralonco 1.1.0, admiralvaccine 0.2.0. (#58)","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/news/index.html","id":"pharmaverseadam-020","dir":"Changelog","previous_headings":"","what":"pharmaverseadam 0.2.0","title":"pharmaverseadam 0.2.0","text":"CRAN release: 2024-01-08","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/news/index.html","id":"new-features-0-2-0","dir":"Changelog","previous_headings":"","what":"New Features","title":"pharmaverseadam 0.2.0","text":"Variables labels applied datasets metacore/metatools. (#50) ADPC, ADPPK ADPP updated handle urine records. (#57)","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/news/index.html","id":"pharmaverseadam-011","dir":"Changelog","previous_headings":"","what":"pharmaverseadam 0.1.1","title":"pharmaverseadam 0.1.1","text":"CRAN release: 2023-09-20","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/news/index.html","id":"new-features-0-1-1","dir":"Changelog","previous_headings":"","what":"New Features","title":"pharmaverseadam 0.1.1","text":"DESCRIPTION file updated ahead CRAN release include references ADaM Implementation Guide 1.3.","code":""},{"path":[]},{"path":"https://pharmaverse.github.io/pharmaverseadam/news/index.html","id":"new-features-0-1-0","dir":"Changelog","previous_headings":"","what":"New Features","title":"pharmaverseadam 0.1.0","text":"Test ADaM data created admiral templates added.","code":""}] +[{"path":"https://pharmaverse.github.io/pharmaverseadam/LICENSE.html","id":null,"dir":"","previous_headings":"","what":"Apache License","title":"Apache License","text":"Version 2.0, January 2004 ","code":""},{"path":[]},{"path":"https://pharmaverse.github.io/pharmaverseadam/LICENSE.html","id":"id_1-definitions","dir":"","previous_headings":"Terms and Conditions for use, reproduction, and distribution","what":"1. Definitions","title":"Apache License","text":"“License” shall mean terms conditions use, reproduction, distribution defined Sections 1 9 document. “Licensor” shall mean copyright owner entity authorized copyright owner granting License. “Legal Entity” shall mean union acting entity entities control, controlled , common control entity. purposes definition, “control” means () power, direct indirect, cause direction management entity, whether contract otherwise, (ii) ownership fifty percent (50%) outstanding shares, (iii) beneficial ownership entity. “” (“”) shall mean individual Legal Entity exercising permissions granted License. “Source” form shall mean preferred form making modifications, including limited software source code, documentation source, configuration files. “Object” form shall mean form resulting mechanical transformation translation Source form, including limited compiled object code, generated documentation, conversions media types. “Work” shall mean work authorship, whether Source Object form, made available License, indicated copyright notice included attached work (example provided Appendix ). “Derivative Works” shall mean work, whether Source Object form, based (derived ) Work editorial revisions, annotations, elaborations, modifications represent, whole, original work authorship. purposes License, Derivative Works shall include works remain separable , merely link (bind name) interfaces , Work Derivative Works thereof. “Contribution” shall mean work authorship, including original version Work modifications additions Work Derivative Works thereof, intentionally submitted Licensor inclusion Work copyright owner individual Legal Entity authorized submit behalf copyright owner. purposes definition, “submitted” means form electronic, verbal, written communication sent Licensor representatives, including limited communication electronic mailing lists, source code control systems, issue tracking systems managed , behalf , Licensor purpose discussing improving Work, excluding communication conspicuously marked otherwise designated writing copyright owner “Contribution”. “Contributor” shall mean Licensor individual Legal Entity behalf Contribution received Licensor subsequently incorporated within Work.","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/LICENSE.html","id":"id_2-grant-of-copyright-license","dir":"","previous_headings":"Terms and Conditions for use, reproduction, and distribution","what":"2. Grant of Copyright License","title":"Apache License","text":"Subject terms conditions License, Contributor hereby grants perpetual, worldwide, non-exclusive, -charge, royalty-free, irrevocable copyright license reproduce, prepare Derivative Works , publicly display, publicly perform, sublicense, distribute Work Derivative Works Source Object form.","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/LICENSE.html","id":"id_3-grant-of-patent-license","dir":"","previous_headings":"Terms and Conditions for use, reproduction, and distribution","what":"3. Grant of Patent License","title":"Apache License","text":"Subject terms conditions License, Contributor hereby grants perpetual, worldwide, non-exclusive, -charge, royalty-free, irrevocable (except stated section) patent license make, made, use, offer sell, sell, import, otherwise transfer Work, license applies patent claims licensable Contributor necessarily infringed Contribution(s) alone combination Contribution(s) Work Contribution(s) submitted. institute patent litigation entity (including cross-claim counterclaim lawsuit) alleging Work Contribution incorporated within Work constitutes direct contributory patent infringement, patent licenses granted License Work shall terminate date litigation filed.","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/LICENSE.html","id":"id_4-redistribution","dir":"","previous_headings":"Terms and Conditions for use, reproduction, and distribution","what":"4. Redistribution","title":"Apache License","text":"may reproduce distribute copies Work Derivative Works thereof medium, without modifications, Source Object form, provided meet following conditions: () must give recipients Work Derivative Works copy License; (b) must cause modified files carry prominent notices stating changed files; (c) must retain, Source form Derivative Works distribute, copyright, patent, trademark, attribution notices Source form Work, excluding notices pertain part Derivative Works; (d) Work includes “NOTICE” text file part distribution, Derivative Works distribute must include readable copy attribution notices contained within NOTICE file, excluding notices pertain part Derivative Works, least one following places: within NOTICE text file distributed part Derivative Works; within Source form documentation, provided along Derivative Works; , within display generated Derivative Works, wherever third-party notices normally appear. contents NOTICE file informational purposes modify License. may add attribution notices within Derivative Works distribute, alongside addendum NOTICE text Work, provided additional attribution notices construed modifying License. may add copyright statement modifications may provide additional different license terms conditions use, reproduction, distribution modifications, Derivative Works whole, provided use, reproduction, distribution Work otherwise complies conditions stated License.","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/LICENSE.html","id":"id_5-submission-of-contributions","dir":"","previous_headings":"Terms and Conditions for use, reproduction, and distribution","what":"5. Submission of Contributions","title":"Apache License","text":"Unless explicitly state otherwise, Contribution intentionally submitted inclusion Work Licensor shall terms conditions License, without additional terms conditions. Notwithstanding , nothing herein shall supersede modify terms separate license agreement may executed Licensor regarding Contributions.","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/LICENSE.html","id":"id_6-trademarks","dir":"","previous_headings":"Terms and Conditions for use, reproduction, and distribution","what":"6. Trademarks","title":"Apache License","text":"License grant permission use trade names, trademarks, service marks, product names Licensor, except required reasonable customary use describing origin Work reproducing content NOTICE file.","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/LICENSE.html","id":"id_7-disclaimer-of-warranty","dir":"","previous_headings":"Terms and Conditions for use, reproduction, and distribution","what":"7. Disclaimer of Warranty","title":"Apache License","text":"Unless required applicable law agreed writing, Licensor provides Work (Contributor provides Contributions) “” BASIS, WITHOUT WARRANTIES CONDITIONS KIND, either express implied, including, without limitation, warranties conditions TITLE, NON-INFRINGEMENT, MERCHANTABILITY, FITNESS PARTICULAR PURPOSE. solely responsible determining appropriateness using redistributing Work assume risks associated exercise permissions License.","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/LICENSE.html","id":"id_8-limitation-of-liability","dir":"","previous_headings":"Terms and Conditions for use, reproduction, and distribution","what":"8. Limitation of Liability","title":"Apache License","text":"event legal theory, whether tort (including negligence), contract, otherwise, unless required applicable law (deliberate grossly negligent acts) agreed writing, shall Contributor liable damages, including direct, indirect, special, incidental, consequential damages character arising result License use inability use Work (including limited damages loss goodwill, work stoppage, computer failure malfunction, commercial damages losses), even Contributor advised possibility damages.","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/LICENSE.html","id":"id_9-accepting-warranty-or-additional-liability","dir":"","previous_headings":"Terms and Conditions for use, reproduction, and distribution","what":"9. Accepting Warranty or Additional Liability","title":"Apache License","text":"redistributing Work Derivative Works thereof, may choose offer, charge fee , acceptance support, warranty, indemnity, liability obligations /rights consistent License. However, accepting obligations, may act behalf sole responsibility, behalf Contributor, agree indemnify, defend, hold Contributor harmless liability incurred , claims asserted , Contributor reason accepting warranty additional liability. END TERMS CONDITIONS","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/LICENSE.html","id":"appendix-how-to-apply-the-apache-license-to-your-work","dir":"","previous_headings":"","what":"APPENDIX: How to apply the Apache License to your work","title":"Apache License","text":"apply Apache License work, attach following boilerplate notice, fields enclosed brackets [] replaced identifying information. (Don’t include brackets!) text enclosed appropriate comment syntax file format. also recommend file class name description purpose included “printed page” copyright notice easier identification within third-party archives.","code":"Copyright 2021 F. Hoffmann-La Roche AG and GlaxoSmithKline LLC Licensed under the Apache License, Version 2.0 (the \"License\"); you may not use this file except in compliance with the License. You may obtain a copy of the License at http://www.apache.org/licenses/LICENSE-2.0 Unless required by applicable law or agreed to in writing, software distributed under the License is distributed on an \"AS IS\" BASIS, WITHOUT WARRANTIES OR CONDITIONS OF ANY KIND, either express or implied. See the License for the specific language governing permissions and limitations under the License."},{"path":"https://pharmaverse.github.io/pharmaverseadam/authors.html","id":null,"dir":"","previous_headings":"","what":"Authors","title":"Authors and Citation","text":"Edoardo Mancini. Author, maintainer. Kangjie Zhang. Author. Stefan Bundfuss. Author. Gayatri G. Author. Daphne Grassely. Author. Zelos Zhu. Author. Sadchla Mascary. Author.","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/authors.html","id":"citation","dir":"","previous_headings":"","what":"Citation","title":"Authors and Citation","text":"Mancini E, Zhang K, Bundfuss S, G G, Grassely D, Zhu Z, Mascary S (2024). pharmaverseadam: ADaM Test Data 'Pharmaverse' Family Packages. R package version 1.0.0, https://github.com/pharmaverse/pharmaverseadam/, https://pharmaverse.github.io/pharmaverseadam/.","code":"@Manual{, title = {pharmaverseadam: ADaM Test Data for the 'Pharmaverse' Family of Packages}, author = {Edoardo Mancini and Kangjie Zhang and Stefan Bundfuss and Gayatri G and Daphne Grassely and Zelos Zhu and Sadchla Mascary}, year = {2024}, note = {R package version 1.0.0, https://github.com/pharmaverse/pharmaverseadam/}, url = {https://pharmaverse.github.io/pharmaverseadam/}, }"},{"path":"https://pharmaverse.github.io/pharmaverseadam/index.html","id":"pharmaverseadam-","dir":"","previous_headings":"","what":"ADaM Test Data for the Pharmaverse Family of Packages","title":"ADaM Test Data for the Pharmaverse Family of Packages","text":"Test data (ADaM) pharmaverse family packages","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/index.html","id":"purpose","dir":"","previous_headings":"","what":"Purpose","title":"ADaM Test Data for the Pharmaverse Family of Packages","text":"provide one-stop-shop ADaM test data pharmaverse family packages.","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/index.html","id":"package-contents","dir":"","previous_headings":"","what":"Package Contents","title":"ADaM Test Data for the Pharmaverse Family of Packages","text":"ADaM contents package populated action executes admiral, admiralonco, admiralophtha admiralvaccine templates saves resulting datasets . action can triggered manually package maintainers two scenarios: Regularly, upon new releases admiral, admiralonco, admiralophtha admiralvaccine; Ad-hoc, whenever templates packages updated releases far away calendar. case, ADaM datasets created using development version templates.","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/index.html","id":"installation","dir":"","previous_headings":"","what":"Installation","title":"ADaM Test Data for the Pharmaverse Family of Packages","text":"package available CRAN can installed running install.packages(\"pharmaverseadam\"). install latest development version package directly GitHub use following code:","code":"if (!requireNamespace(\"remotes\", quietly = TRUE)) { install.packages(\"remotes\") } remotes::install_github(\"pharmaverse/pharmaverseadam\", ref = \"main\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adae.html","id":null,"dir":"Reference","previous_headings":"","what":"Adverse Events Analysis — adae","title":"Adverse Events Analysis — adae","text":"example ADAE ADaM dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adae.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Adverse Events Analysis — adae","text":"","code":"adae"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adae.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Adverse Events Analysis — adae","text":"data frame 101 columns: STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier AESEQ Sequence Number AESPID Sponsor-Defined Identifier AETERM Reported Term 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 Organ Class AEBDSYCD Body System Organ Class Code AESOC Primary System Organ Class AESOCCD Primary System Organ Class Code AESEV Severity/Intensity AESER Serious Event AEACN Action Taken Study Treatment AEREL Causality AEOUT Outcome Adverse Event AESCAN Involves Cancer AESCONG Congenital Anomaly Birth Defect AESDISAB Persist Signif Disability/Incapacity AESDTH Results Death AESHOSP Requires Prolongs Hospitalization AESLIFE Life Threatening AESOD Occurred Overdose AEDTC Date/Time Collection AESTDTC Start Date/Time Adverse Event AEENDTC End Date/Time Adverse Event AESTDY Study Day Start Adverse Event AEENDY Study Day End Adverse Event TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment DTHDT Date Death EOSDT End 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 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 Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRT01P Planned Treatment Period 01 TRT01A Actual Treatment Period 01 TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adae.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Adverse Events Analysis — adae","text":"Generated admiral package (template ad_adae.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adae.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Adverse Events Analysis — adae","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adae.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Adverse Events Analysis — adae","text":"","code":"data(\"adae\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adbcva_ophtha.html","id":null,"dir":"Reference","previous_headings":"","what":"Best Corrected Visual Acuity Analysis — adbcva_ophtha","title":"Best Corrected Visual Acuity Analysis — adbcva_ophtha","text":"example ADBCVA ADaM dataset Ophthalmology studies","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adbcva_ophtha.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Best Corrected Visual Acuity Analysis — adbcva_ophtha","text":"","code":"adbcva_ophtha"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adbcva_ophtha.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Best Corrected Visual Acuity Analysis — adbcva_ophtha","text":"data frame 116 columns: STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier OESEQ Sequence Number OECAT Category Ophthalmic Test Exam OESCAT Subcategory Ophthalmic Test Exam OEDTC Date/Time Collection VISIT Visit Name VISITNUM Visit Number VISITDY Planned Study Day Visit OESTRESN Numeric Result/Finding Standard Units OESTRESC Character Result/Finding Std Format OEORRES Result Finding Original Units OETEST Name Ophthalmic Test Exam OETESTCD Short Name Ophthalmic Test Exam OETSTDTL Ophthalmic Test Exam Detail OELAT Laterality OELOC Location Used Measurement OEDY Study Day Visit/Collection/Exam OEMETHOD Method Test Examination OEORRESU Original Units OESTRESU Standard Units OESTAT Completion Status OETPT Planned Time Point Name OETPTNUM Planned Time Point Number TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment TRT01A Actual Treatment Period 01 TRT01P Planned Treatment 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 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 Baseline PCHG Percent Change Baseline ASEQ Analysis Sequence Number SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country/Region DMDTC Date/Time Collection DMDY Study Day Collection TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSDT End Study Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHDT Date Death DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days 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","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adbcva_ophtha.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Best Corrected Visual Acuity Analysis — adbcva_ophtha","text":"Generated admiralophtha package (template ad_adbcva.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adbcva_ophtha.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Best Corrected Visual Acuity Analysis — adbcva_ophtha","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adbcva_ophtha.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Best Corrected Visual Acuity Analysis — adbcva_ophtha","text":"","code":"data(\"adbcva_ophtha\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adce_vaccine.html","id":null,"dir":"Reference","previous_headings":"","what":"Clinical Events Analysis for Vaccine — adce_vaccine","title":"Clinical Events Analysis for Vaccine — adce_vaccine","text":"example ADCE dataset Vaccine studies","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adce_vaccine.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Clinical Events Analysis for Vaccine — adce_vaccine","text":"","code":"adce_vaccine"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adce_vaccine.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Clinical Events Analysis for Vaccine — adce_vaccine","text":"data frame 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 Clinical Event CEDECOD Dictionary-Derived Term CELAT Laterality CELOC Location Event CECAT Category Clinical Event CESCAT Subcategory Clinical Event CEPRESP Clinical Event Pre-specified CEOCCUR Clinical Event Occurrence CESEV Severity/Intensity CEREL Causality CEOUT Outcome Event EPOCH Epoch CEDTC Date/Time Event Collection CESTDTC Start Date/Time Clinical Event CEENDTC End Date/Time Clinical Event CEDUR Duration Clinical Event CETPT Planned Time Point Name CETPTNUM Planned Time Point Number CETPTREF Time Point Reference CERFTDTC Date/Time Reference Time Point CEEVINTX Evaluation Interval Text CESTAT Completion Status CEREASND Reason Clinical Event Collected TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure 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 Period 01 TRT01P Planned Treatment Period 01 AGE Age AGEU Age Units SEX Sex RACE Race COUNTRY Country ETHNIC Ethnicity SITEID Study Site Identifier SUBJID Subject Identifier Study","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adce_vaccine.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Clinical Events Analysis for Vaccine — adce_vaccine","text":"Generated admiralvaccine package (template ad_adce.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adce_vaccine.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Clinical Events Analysis for Vaccine — adce_vaccine","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adce_vaccine.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Clinical Events Analysis for Vaccine — adce_vaccine","text":"","code":"data(\"adce_vaccine\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adcm.html","id":null,"dir":"Reference","previous_headings":"","what":"Concomitant Medications Analysis — adcm","title":"Concomitant Medications Analysis — adcm","text":"example ADCM ADaM dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adcm.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Concomitant Medications Analysis — adcm","text":"","code":"adcm"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adcm.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Concomitant Medications Analysis — adcm","text":"data frame 90 columns: STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier CMSEQ Sequence Number CMSPID Sponsor-Defined Identifier CMTRT Reported Name Drug, Med, Therapy CMDECOD Standardized Medication Name CMINDC Indication CMCLAS Medication Class CMDOSE Dose per Administration CMDOSU Dose Units CMDOSFRQ Dosing Frequency per Interval CMROUTE Route Administration VISITNUM Visit Number VISIT Visit Name VISITDY Planned Study Day Visit CMDTC Date/Time Collection CMSTDTC Start Date/Time Medication CMENDTC End Date/Time Medication CMSTDY Study Day Start Medication CMENDY Study Day End Medication TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment DTHDT Date Death EOSDT End Study Date TRT01P Planned Treatment Period 01 TRT01A Actual Treatment 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 Treatment Record Flag PREFL Pre-treatment Flag FUPFL Follow-Flag ANL01FL Analysis Flag 01 AOCCPFL 1st Occurrence Preferred Term Flag APHASE Phase APHASEN Description Phase N TRTP Planned Treatment TRTA Actual Treatment SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Treatment End Datetime Imput Flag TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adcm.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Concomitant Medications Analysis — adcm","text":"Generated admiral package (template ad_adcm.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adcm.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Concomitant Medications Analysis — adcm","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adcm.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Concomitant Medications Analysis — adcm","text":"","code":"data(\"adcm\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adeg.html","id":null,"dir":"Reference","previous_headings":"","what":"Electrocardiogram Tests Analysis — adeg","title":"Electrocardiogram Tests Analysis — adeg","text":"example ADEG ADaM dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adeg.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Electrocardiogram Tests Analysis — adeg","text":"","code":"adeg"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adeg.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Electrocardiogram Tests Analysis — adeg","text":"data frame 105 columns: STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier EGSEQ Sequence Number EGTESTCD ECG Test Examination Short Name EGTEST ECG Test Examination Name EGORRES Result Finding Original Units EGORRESU Original Units EGSTRESC Character Result/Finding Std Format EGSTRESN Numeric Result/Finding Standard Units EGSTRESU Standard Units EGSTAT Completion Status EGLOC Lead Location Used Measurement EGBLFL Baseline Flag VISITNUM Visit Number VISIT Visit Name VISITDY Planned Study Day Visit EGDTC Date/Time ECG EGDY Study Day ECG EGTPT Planned Time Point Name EGTPTNUM Planned Time Point Number EGELTM Planned Elapsed Time Time Point Ref EGTPTREF Time Point Reference temp undocumented field TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment TRT01A Actual Treatment Period 01 TRT01P Planned Treatment 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 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 Baseline PCHG Percent Change Baseline ANL01FL Analysis Flag 01 TRTP Planned Treatment TRTA Actual Treatment ASEQ Analysis Sequence Number AVALCA1N Analysis Value Category 1 (N) AVALCAT1 Analysis Value Category 1 CHGCAT1N Change Baseline Category 1 (N) CHGCAT1 Change Baseline Category 1 PARAM Parameter PARAMN Parameter (N) SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSDT End Study Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHDT Date Death DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adeg.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Electrocardiogram Tests Analysis — adeg","text":"Generated admiral package (template ad_adeg.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adeg.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Electrocardiogram Tests Analysis — adeg","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adeg.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Electrocardiogram Tests Analysis — adeg","text":"","code":"data(\"adeg\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adex.html","id":null,"dir":"Reference","previous_headings":"","what":"Exposure Analysis — adex","title":"Exposure Analysis — adex","text":"example ADEX ADaM dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adex.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Exposure Analysis — adex","text":"","code":"adex"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adex.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Exposure Analysis — adex","text":"data frame 88 columns: STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier EXSEQ Sequence Number EXTRT Name Treatment EXDOSE Dose EXDOSU Dose Units EXDOSFRM Dose Form EXDOSFRQ Dosing Frequency per Interval EXROUTE Route Administration VISITNUM Visit Number VISIT Visit Name VISITDY Planned Study Day Visit EXSTDTC Start Date/Time Treatment EXENDTC End Date/Time Treatment EXSTDY Study Day Start Treatment EXENDY Study Day End Treatment EXADJ Reason Dose Adjustment EXPLDOS Planned Dose TRTSDT Date First Exposure Treatment TRTSDTM Datetime First Exposure Treatment TRTEDTM Datetime Last Exposure 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 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 Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRT01P Planned Treatment Period 01 TRT01A Actual Treatment Period 01 TRTSTMF Time First Exposure Imput. Flag TRTETMF Time Last Exposure Imput. Flag TRTEDT Date Last Exposure Treatment TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSDT End Study Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHDT Date Death DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adex.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Exposure Analysis — adex","text":"Generated admiral package (template ad_adex.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adex.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Exposure Analysis — adex","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adex.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Exposure Analysis — adex","text":"","code":"data(\"adex\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adface_vaccine.html","id":null,"dir":"Reference","previous_headings":"","what":"Findings About Clinical Events Analysis — adface_vaccine","title":"Findings About Clinical Events Analysis — adface_vaccine","text":"example ADFACE Vaccine studies","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adface_vaccine.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Findings About Clinical Events Analysis — adface_vaccine","text":"","code":"adface_vaccine"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adface_vaccine.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Findings About Clinical Events Analysis — adface_vaccine","text":"data frame 60 columns: STUDYID Study Identifier USUBJID Unique Subject Identifier SUBJID Subject Identifier Study SITEID Study Site Identifier AGE Age AGEU Age Units SEX Sex RACE Race SAFFL Safety Population Flag ARM Description Planned Arm ARMCD Planned Arm Code ACTARM Description Actual Arm ACTARMCD Actual Arm Code TRTSDT Date First Exposure Treatment TRTSDTM Datetime First Exposure Treatment TRTEDT Date Last Exposure Treatment TRTEDTM Datetime Last Exposure Treatment FATEST Findings Test Name FALNKID Link ID FALNKGRP Link Group ID FATESTCD Findings Test Short Name PARAMCD Parameter Code PARAM Parameter PARAMN Parameter (N) FAOBJ Object Observation PARCAT1 Parameter Category 1 PARCAT2 Parameter Category 2 AVALC Analysis Value (C) AVAL Analysis Value FASTAT Completion Status FAREASND Reason 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 Treatment EXSTDTC Start Date/Time Treatment EXENDTC End Date/Time Treatment TRTA Actual Treatment TRTP Planned Treatment APERIOD Period APERSDT Period Start Date APEREDT Period End Date FAORRES Result Finding Original Units TRT01P Planned Treatment Period 01 TRT02P Planned Treatment Period 02 TRT01A Actual Treatment Period 01 TRT02A Actual Treatment 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","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adface_vaccine.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Findings About Clinical Events Analysis — adface_vaccine","text":"Generated admiralvaccine package (template ad_adface.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adface_vaccine.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Findings About Clinical Events Analysis — adface_vaccine","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adface_vaccine.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Findings About Clinical Events Analysis — adface_vaccine","text":"","code":"data(\"adface_vaccine\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adis_vaccine.html","id":null,"dir":"Reference","previous_headings":"","what":"Immunogenicity Specimen Assessments — adis_vaccine","title":"Immunogenicity Specimen Assessments — adis_vaccine","text":"example ADIS dataset Vaccine studies","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adis_vaccine.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Immunogenicity Specimen Assessments — adis_vaccine","text":"","code":"adis_vaccine"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adis_vaccine.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Immunogenicity Specimen Assessments — adis_vaccine","text":"data frame 102 columns: STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier ISSEQ Sequence Number ISTESTCD Immunogenicity Test/Exam Short Name ISTEST Immunogenicity Test Examination Name ISCAT Category Immunogenicity Test ISORRES Results Findings Original Units ISORRESU Original Units ISSTRESC Character Result/Finding Std Format ISSTRESN Numeric Results/Findings Std. Units ISSTRESU Standard Units ISSTAT Completion Status ISREASND Reason Done ISNAM Vendor Name ISSPEC Specimen Type ISMETHOD Method Test Examination ISBLFL Baseline Flag ISLLOQ Lower Limit Quantitation VISITNUM Visit Number EPOCH Epoch ISDTC Date/Time Collection ISDY Study Day Visit/Collection/Exam ISULOQ Upper Limit Quantitation LOD Limit 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 Baseline R2BASE Ratio 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 Study RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time Death DTHFL Subject Death Flag SITEID Study Site Identifier INVID Investigator Identifier INVNAM Investigator Name BRTHDTC Date/Time Birth AGE Age AGEU Age Units SEX Sex RACE Race ETHNIC Ethnicity ARMCD Planned Arm Code ARM Description Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRT01P Planned Treatment Period 01 TRT02P Planned Treatment Period 02 TRT01A Actual Treatment Period 01 TRT02A Actual Treatment Period 02 TRTSDTM Datetime First Exposure Treatment TRTEDTM Datetime Last Exposure Treatment TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure 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","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adis_vaccine.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Immunogenicity Specimen Assessments — adis_vaccine","text":"Generated admiralvaccine package (template ad_adis.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adis_vaccine.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Immunogenicity Specimen Assessments — adis_vaccine","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adis_vaccine.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Immunogenicity Specimen Assessments — adis_vaccine","text":"","code":"data(\"adis_vaccine\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlb.html","id":null,"dir":"Reference","previous_headings":"","what":"Laboratory Analysis — adlb","title":"Laboratory Analysis — adlb","text":"example ADLB ADaM dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlb.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Laboratory Analysis — adlb","text":"","code":"adlb"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlb.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Laboratory Analysis — adlb","text":"data frame 111 columns: STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier LBSEQ Sequence Number LBTESTCD Lab Test Examination Short Name LBTEST Lab Test Examination Name LBCAT Category Lab Test LBORRES Result Finding Original Units LBORRESU Original Units LBORNRLO Reference Range Lower Limit Orig Unit LBORNRHI Reference Range Upper Limit Orig Unit LBSTRESC Character Result/Finding Std Format LBSTRESN Numeric Result/Finding 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 Visit LBDTC Date/Time Specimen Collection LBDY Study Day Specimen Collection TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment TRT01A Actual Treatment Period 01 TRT01P Planned Treatment 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 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 Baseline PCHG Percent Change 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 Baseline R2ANRLO Ratio Analysis Val compared ANRLO R2ANRHI Ratio Analysis Val compared ANRHI SHIFT1 Shift Baseline Analysis Value SHIFT2 Shift Baseline Overall Grade ANL01FL Analysis Flag 01 LVOTFL Last Value Treatment Record Flag TRTP Planned Treatment TRTA Actual Treatment ASEQ Analysis Sequence Number SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSDT End Study Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHDT Date Death DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlb.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Laboratory Analysis — adlb","text":"Generated admiral package (template ad_adlb.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlb.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Laboratory Analysis — adlb","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlb.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Laboratory Analysis — adlb","text":"","code":"data(\"adlb\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlbhy.html","id":null,"dir":"Reference","previous_headings":"","what":"Analysis of Lab Hy's Law — adlbhy","title":"Analysis of Lab Hy's Law — adlbhy","text":"template ADLBHY dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlbhy.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Analysis of Lab Hy's Law — adlbhy","text":"","code":"adlbhy"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlbhy.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Analysis of Lab Hy's Law — adlbhy","text":"data frame 14 columns: STUDYID Study Identifier USUBJID Unique Subject Identifier TRT01A Actual Treatment 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","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlbhy.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Analysis of Lab Hy's Law — adlbhy","text":"Generated admiral package (template ad_adlbhy.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlbhy.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Analysis of Lab Hy's Law — adlbhy","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adlbhy.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Analysis of Lab Hy's Law — adlbhy","text":"","code":"data(\"adlbhy\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/admh.html","id":null,"dir":"Reference","previous_headings":"","what":"Medical History Analysis — admh","title":"Medical History Analysis — admh","text":"template ADMH ADaM dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/admh.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Medical History Analysis — admh","text":"","code":"admh"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/admh.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Medical History Analysis — admh","text":"data frame 110 columns: STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier MHSEQ Sequence Number MHSPID Sponsor-Defined Identifier MHTERM Reported Term Medical History MHLLT Lowest Level Term MHDECOD Dictionary-Derived Term MHHLT High Level Term MHHLGT High Level Group Term MHCAT Category Medical History MHBODSYS Body System Organ Class MHSEV Severity/Intensity VISITNUM Visit Number VISIT Visit Name VISITDY Planned Study Day Visit MHDTC Date/Time History Collection MHSTDTC Start Date/Time Medical History Event MHDY Study Day History Collection MHENDTC End Date/Time Medical History Event MHPRESP Medical History Event Pre-Specified MHOCCUR Medical History Occurrence MHSTRTPT Start Relative Reference Time Point MHENRTPT End Relative Reference Time Point MHSTTPT Start Reference Time Point MHENTPT End Reference Time Point MHENRF End Relative Reference Period MHSTAT Completion Status TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment TRT01A Actual Treatment Period 01 TRT01P Planned Treatment Period 01 DTHDT Date Death EOSDT End 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 Med Hx (past current) AOCCFL 1st Occurrence within Subject Flag AOCCSFL 1st Occurrence SOC Flag AOCCPFL 1st Occurrence Preferred Term Flag AOCPFL 1st Occur w/Trt Prd FL AOCPSFL 1st Occur SOC w/Trt Prd FL AOCPPFL 1st Occur PT w/Trt Prd FL ANL01FL Analysis Flag 01 TRTP Planned Treatment TRTA Actual Treatment APHASE Phase APHASEN Description Phase N MHTERMN Medical History Term (N) SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Treatment End Datetime Imput Flag TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/admh.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Medical History Analysis — admh","text":"Generated admiral package (template ad_admh.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/admh.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Medical History Analysis — admh","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/admh.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Medical History Analysis — admh","text":"","code":"data(\"admh\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adoe_ophtha.html","id":null,"dir":"Reference","previous_headings":"","what":"Exam Analysis for Ophthalmology — adoe_ophtha","title":"Exam Analysis for Ophthalmology — adoe_ophtha","text":"example ADOE dataset Ophthalmology studies","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adoe_ophtha.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Exam Analysis for Ophthalmology — adoe_ophtha","text":"","code":"adoe_ophtha"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adoe_ophtha.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Exam Analysis for Ophthalmology — adoe_ophtha","text":"data frame 98 columns: STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier OESEQ Sequence Number OECAT Category Ophthalmic Test Exam OESCAT Subcategory Ophthalmic Test Exam OEDTC Date/Time Collection VISIT Visit Name VISITNUM Visit Number VISITDY Planned Study Day Visit OESTRESN Numeric Result/Finding Standard Units OESTRESC Character Result/Finding Std Format OEORRES Result Finding Original Units OETEST Name Ophthalmic Test Exam OETESTCD Short Name Ophthalmic Test Exam OETSTDTL Ophthalmic Test Exam Detail OELAT Laterality OELOC Location Used Measurement OEDY Study Day Visit/Collection/Exam OEMETHOD Method Test Examination OEORRESU Original Units OESTRESU Standard Units OESTAT Completion Status OETPT Planned Time Point Name OETPTNUM Planned Time Point Number TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment TRT01A Actual Treatment Period 01 TRT01P Planned Treatment 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 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 Baseline PCHG Percent Change Baseline ASEQ Analysis Sequence Number SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSDT End Study Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHDT Date Death DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adoe_ophtha.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Exam Analysis for Ophthalmology — adoe_ophtha","text":"Generated admiralophtha package (template ad_adoe.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adoe_ophtha.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Exam Analysis for Ophthalmology — adoe_ophtha","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adoe_ophtha.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Exam Analysis for Ophthalmology — adoe_ophtha","text":"","code":"data(\"adoe_ophtha\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpc.html","id":null,"dir":"Reference","previous_headings":"","what":"Pharmacokinetic Concentrations — adpc","title":"Pharmacokinetic Concentrations — adpc","text":"example ADPC dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpc.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Pharmacokinetic Concentrations — adpc","text":"","code":"adpc"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpc.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Pharmacokinetic Concentrations — adpc","text":"data frame 123 columns: STUDYID Study Identifier USUBJID Unique Subject Identifier NFRLT Nom. Rel. Time Analyte First Dose PCTESTCD Pharmacokinetic Test Short Name PCTEST Pharmacokinetic Test Name PCORRES Result Finding Original Units PCORRESU Original Units PCSTRESC Character Result/Finding Std Format PCSTRESN Numeric Result/Finding Standard Units PCSTRESU Standard Units PCNAM Vendor Name PCSPEC Specimen Material Type PCLLOQ Lower Limit Quantitation VISIT Visit Name VISITNUM Visit Number PCDTC Date/Time Specimen Collection PCDY Actual Study Day Specimen Collection PCTPT Planned Time Point Name PCTPTNUM Planned Time Point Number TRTSDT Date First Exposure Treatment TRTSDTM Datetime First Exposure Treatment TRT01P Planned Treatment Period 01 TRT01A Actual Treatment Period 01 ADTM Analysis Datetime ATMF Analysis Time Imputation Flag ADT Analysis Date ATM Analysis Time ADY Analysis Relative Day FANLDTM First Datetime Dose 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 Analyte First Dose ARRLT Actual Rel. Time Ref. Dose PCRFTDTM Reference Datetime Dose Analyte FANLDT First Date Dose Analyte FANLTM First Time Dose Analyte PCRFTDT Reference Date Dose Analyte PCRFTTM Reference Time Dose Analyte NRRLT Nominal Rel. Time 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 First Dose Unit RRLTU Rel. Time Ref. Dose Unit PARAMCD Parameter Code ALLOQ Analysis Lower Limit 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 Ref. Dose ANL01FL Analysis Flag 01 ANL02FL Analysis Flag 02 BASE Baseline Value CHG Change Baseline ASEQ Analysis Sequence Number PARAM Parameter PARAMN Parameter (N) HTBL Numeric Result/Finding Standard Units HTBLU Standard Units WTBL Numeric Result/Finding Standard Units WTBLU Standard Units BMIBL Baseline Body Mass Index (kg/m2) BMIBLU BMI Baseline (Unit) SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTEDT Date Last Exposure Treatment TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSDT End Study Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHDT Date Death DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL 30 Group DTHA30FL 30 Group DTHB30FL 30 plus 30 days Group","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpc.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Pharmacokinetic Concentrations — adpc","text":"Generated admiral package (template ad_adpc.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpc.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Pharmacokinetic Concentrations — adpc","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpc.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Pharmacokinetic Concentrations — adpc","text":"","code":"data(\"adpc\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpp.html","id":null,"dir":"Reference","previous_headings":"","what":"Pharmacokinetic Parameters — adpp","title":"Pharmacokinetic Parameters — adpp","text":"example ADPP ADaM dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpp.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Pharmacokinetic Parameters — adpp","text":"","code":"adpp"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpp.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Pharmacokinetic Parameters — adpp","text":"data frame 75 columns: STUDYID Study Identifier USUBJID Unique Subject Identifier PPTESTCD Parameter Short Name PPTEST Parameter Name PPCAT Parameter Category PPORRES Result Finding Original Units PPORRESU Original Units PPSTRESU Standard Units PPSPEC Specimen Material Type PPRFDTC Date/Time Reference Point TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment DTHDT Date Death EOSDT End Study Date TRT01P Planned Treatment Period 01 TRT01A Actual Treatment Period 01 ADT Analysis Date ADY Analysis Relative Day PARAMCD Parameter Code PARCAT1 Parameter Category AVAL Numeric Result/Finding 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 AVALCA1N Analysis Value Category 1 (N) AVALCAT1 Analysis Value Category 1 SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpp.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Pharmacokinetic Parameters — adpp","text":"Generated admiral package (template ad_adpp.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpp.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Pharmacokinetic Parameters — adpp","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adpp.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Pharmacokinetic Parameters — adpp","text":"","code":"data(\"adpp\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adppk.html","id":null,"dir":"Reference","previous_headings":"","what":"Population Pharmacokinetic — adppk","title":"Population Pharmacokinetic — adppk","text":"template ADPPK ADaM dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adppk.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Population Pharmacokinetic — adppk","text":"","code":"adppk"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adppk.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Population Pharmacokinetic — adppk","text":"data frame 61 columns: STUDYID Study Identifier USUBJID Unique Subject Identifier EVID Event ID NFRLT Nom. Rel. Time Analyte First Dose AFRLT Act. Rel. Time Analyte First Dose APRLT Actual Rel Time Previous Dose NPRLT Nominal Rel Time Previous Dose DOSEA Actual Treatment Dose DOSEP Planned Treatment Dose PARAMCD Parameter Code ALLOQ Analysis Lower Limit Quantitation CMT Compartment BLQFL Lower Limit Quant Flag BLQFN Lower Limit Quant Flag (N) AMT Actual Amount 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 Study SUBJIDN Subject Identifier Study (N) AGE Age SEX Sex SEXN Sex (N) COHORT Cohort Subject Enrolled COHORTC Description Planned Arm ROUTE Route Administration ROUTEN Route 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 Standard Units WTBL Numeric Result/Finding Standard Units ALTBL Numeric Result/Finding Standard Units ASTBL Numeric Result/Finding Standard Units TBILBL Numeric Result/Finding Standard Units CREATBL Numeric Result/Finding Standard Units BMIBL Baseline Body Mass Index (kg/m2) BSABL Numeric Result/Finding Standard Units CRCLBL Baseline Creatinine Clearance EGFRBL Age RECSEQ Record Sequence","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adppk.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Population Pharmacokinetic — adppk","text":"Generated admiral package (template ad_adppk.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adppk.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Population Pharmacokinetic — adppk","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adppk.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Population Pharmacokinetic — adppk","text":"","code":"data(\"adppk\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adrs_onco.html","id":null,"dir":"Reference","previous_headings":"","what":"Tumor Response Analysis — adrs_onco","title":"Tumor Response Analysis — adrs_onco","text":"example ADRS dataset Oncology studies","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adrs_onco.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Tumor Response Analysis — adrs_onco","text":"","code":"adrs_onco"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adrs_onco.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Tumor Response Analysis — adrs_onco","text":"data frame 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 Finding Original Units RSSTRESC Character Result/Finding Std Format RSEVAL Evaluator RSEVALID Evaluator Identifier RSACPTFL Accepted Record Flag RSDTC Date/Time Assessment RSSEQ Sequence Number RANDDT Date 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 Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRT01P Planned Treatment Period 01 TRT01A Actual Treatment Period 01 TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSDT End Study Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date DTHDT Date Death DTHDTF Date Death Imputation Flag DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death DTHCAUS Cause Death DTHDOM Domain Date Death Collection DTHCGR1 Cause 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 Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adrs_onco.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Tumor Response Analysis — adrs_onco","text":"Generated admiralonco package (template ad_adrs.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adrs_onco.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Tumor Response Analysis — adrs_onco","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adrs_onco.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Tumor Response Analysis — adrs_onco","text":"","code":"data(\"adrs_onco\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl.html","id":null,"dir":"Reference","previous_headings":"","what":"Subject Level Analysis — adsl","title":"Subject Level Analysis — adsl","text":"example ADSL ADaM dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Subject Level Analysis — adsl","text":"","code":"adsl"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Subject Level Analysis — adsl","text":"data frame 54 columns: STUDYID Study Identifier USUBJID Unique Subject Identifier SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRT01P Planned Treatment Period 01 TRT01A Actual Treatment Period 01 TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSDT End Study Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHDT Date Death DTHDTF Date Death Imputation Flag DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose 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 Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Subject Level Analysis — adsl","text":"Generated admiral package (template ad_adsl.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Subject Level Analysis — adsl","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Subject Level Analysis — adsl","text":"","code":"data(\"adsl\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl_vaccine.html","id":null,"dir":"Reference","previous_headings":"","what":"Subject Level Analysis for Vaccine — adsl_vaccine","title":"Subject Level Analysis for Vaccine — adsl_vaccine","text":"example ADSL ADaM dataset Vaccine studies","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl_vaccine.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Subject Level Analysis for Vaccine — adsl_vaccine","text":"","code":"adsl_vaccine"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl_vaccine.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Subject Level Analysis for Vaccine — adsl_vaccine","text":"data frame 46 columns: STUDYID Study Identifier USUBJID Unique Subject Identifier SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time Death DTHFL Subject Death Flag SITEID Study Site Identifier INVID Investigator Identifier INVNAM Investigator Name BRTHDTC Date/Time Birth AGE Age AGEU Age Units SEX Sex RACE Race ETHNIC Ethnicity ARMCD Planned Arm Code ARM Description Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country/Region DMDTC Date/Time Collection DMDY Study Day Collection TRT01P Planned Treatment Period 01 TRT02P Planned Treatment Period 02 TRT01A Actual Treatment Period 01 TRT02A Actual Treatment Period 02 TRTSDTM Datetime First Exposure Treatment TRTEDTM Datetime Last Exposure Treatment TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure 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","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl_vaccine.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Subject Level Analysis for Vaccine — adsl_vaccine","text":"Generated admiralvaccine package (template ad_adsl.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl_vaccine.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Subject Level Analysis for Vaccine — adsl_vaccine","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adsl_vaccine.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Subject Level Analysis for Vaccine — adsl_vaccine","text":"","code":"data(\"adsl_vaccine\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtr_onco.html","id":null,"dir":"Reference","previous_headings":"","what":"Tumor Results Analysis for Oncology — adtr_onco","title":"Tumor Results Analysis for Oncology — adtr_onco","text":"example ADTR ADaM dataset Oncology studies","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtr_onco.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Tumor Results Analysis for Oncology — adtr_onco","text":"","code":"adtr_onco"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtr_onco.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Tumor Results Analysis for Oncology — adtr_onco","text":"data frame 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 Finding Original Units TRORRESU Original Units TRSTRESC Character Result/Finding Std Format TRSTRESN Numeric Result/Finding Standard Units TRSTRESU Standard Units VISITNUM Visit Number VISIT Visit Name TREVAL Evaluator TREVALID Evaluator Identifier TRACPTFL Accepted Record Flag TRDTC Date/Time Tumor/Lesion Measurement TRSEQ Sequence Number RANDDT Date Randomization TULOC Location 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 Baseline PCHG Percent Change Baseline CHGNAD Change NADIR PCHGNAD Percent Change 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 Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRT01P Planned Treatment Period 01 TRT01A Actual Treatment Period 01 TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSDT End Study Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date DTHDT Date Death DTHDTF Date Death Imputation Flag DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death DTHCAUS Cause Death DTHDOM Domain Date Death Collection DTHCGR1 Cause 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 Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtr_onco.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Tumor Results Analysis for Oncology — adtr_onco","text":"Generated admiralonco package (template ad_adtr.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtr_onco.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Tumor Results Analysis for Oncology — adtr_onco","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtr_onco.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Tumor Results Analysis for Oncology — adtr_onco","text":"","code":"data(\"adtr_onco\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtte_onco.html","id":null,"dir":"Reference","previous_headings":"","what":"Time to Event Analysis for Oncology — adtte_onco","title":"Time to Event Analysis for Oncology — adtte_onco","text":"example ADTTE ADaM dataset Oncology studies","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtte_onco.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Time to Event Analysis for Oncology — adtte_onco","text":"","code":"adtte_onco"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtte_onco.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Time to Event Analysis for Oncology — adtte_onco","text":"data frame 20 columns: STUDYID Study Identifier USUBJID Unique Subject Identifier ADT Analysis Date EVNTDESC Event Censoring Description SRCDOM Source Data SRCVAR Source Variable SRCSEQ Source Sequence Number CNSR Censor CNSDTDSC Censor Date Description STARTDT Time--Event Origin Date Subject PARAMCD Parameter Code PARAM Parameter AVAL Analysis Value ASEQ Analysis Sequence Number ARMCD Planned Arm Code ARM Description Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm AGE Age SEX Sex","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtte_onco.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Time to Event Analysis for Oncology — adtte_onco","text":"Generated admiralonco package (template ad_adtte.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtte_onco.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Time to Event Analysis for Oncology — adtte_onco","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/adtte_onco.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Time to Event Analysis for Oncology — adtte_onco","text":"","code":"data(\"adtte_onco\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advfq_ophtha.html","id":null,"dir":"Reference","previous_headings":"","what":"Visual Function Questionnaire Analysis — advfq_ophtha","title":"Visual Function Questionnaire Analysis — advfq_ophtha","text":"example ADVFQ ADaM dataset Ophthalmology studies","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advfq_ophtha.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Visual Function Questionnaire Analysis — advfq_ophtha","text":"","code":"advfq_ophtha"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advfq_ophtha.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Visual Function Questionnaire Analysis — advfq_ophtha","text":"data frame 85 columns: STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier QSSEQ Sequence Number QSTESTCD Question Short Name QSTEST Question Name QSCAT Category Question QSSCAT Subcategory Question QSORRES Finding Original Units QSORRESU Original Units QSSTRESC Character Result/Finding Std Format QSSTRESN Numeric Finding Standard Units QSSTRESU Standard Units QSBLFL Baseline Flag QSDRVFL Derived Flag VISITNUM Visit Number VISIT Visit Name VISITDY Planned Study Day Visit QSDTC Date/Time Finding QSDY Study Day Finding TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment TRT01A Actual Treatment Period 01 TRT01P Planned Treatment 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 Treatment Record Flag ABLFL Baseline Record Flag BASE Baseline Value CHG Change Baseline PCHG Percent Change Baseline ANL01FL Analysis Flag 01 ASEQ Analysis Sequence Number PARAM Parameter PARCAT1 Parameter Category 1 PARCAT2 Parameter Category 2 SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSDT End Study Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHDT Date Death DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advfq_ophtha.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Visual Function Questionnaire Analysis — advfq_ophtha","text":"Generated admiralophtha package (template ad_advfq.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advfq_ophtha.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Visual Function Questionnaire Analysis — advfq_ophtha","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advfq_ophtha.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Visual Function Questionnaire Analysis — advfq_ophtha","text":"","code":"data(\"advfq_ophtha\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advs.html","id":null,"dir":"Reference","previous_headings":"","what":"Vital Signs Analysis — advs","title":"Vital Signs Analysis — advs","text":"example ADVS ADaM dataset","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advs.html","id":"ref-usage","dir":"Reference","previous_headings":"","what":"Usage","title":"Vital Signs Analysis — advs","text":"","code":"advs"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advs.html","id":"format","dir":"Reference","previous_headings":"","what":"Format","title":"Vital Signs Analysis — advs","text":"data frame 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 Subject VSORRES Result Finding Original Units VSORRESU Original Units VSSTRESC Character Result/Finding Std Format VSSTRESN Numeric Result/Finding Standard Units VSSTRESU Standard Units VSSTAT Completion Status VSLOC Location Vital Signs Measurement VSBLFL Baseline Flag VISITNUM Visit Number VISIT Visit Name VISITDY Planned Study Day Visit VSDTC Date/Time Measurements VSDY Study Day Vital Signs VSTPT Planned Time Point Name VSTPTNUM Planned Time Point Number VSELTM Planned Elapsed Time Time Point Ref VSTPTREF Time Point Reference TRTSDT Date First Exposure Treatment TRTEDT Date Last Exposure Treatment TRT01A Actual Treatment Period 01 TRT01P Planned Treatment 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 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 Baseline PCHG Percent Change Baseline ANL01FL Analysis Flag 01 TRTP Planned Treatment TRTA Actual Treatment ASEQ Analysis Sequence Number AVALCA1N Analysis Value Category 1 (N) AVALCAT1 Analysis Value Category 1 PARAM Parameter PARAMN Parameter (N) SUBJID Subject Identifier Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time First Study Treatment RFXENDTC Date/Time Last Study Treatment RFICDTC Date/Time Informed Consent RFPENDTC Date/Time End Participation DTHDTC Date/Time 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 Planned Arm ACTARMCD Actual Arm Code ACTARM Description Actual Arm COUNTRY Country DMDTC Date/Time Collection DMDY Study Day Collection TRTSDTM Datetime First Exposure Treatment TRTSTMF Time First Exposure Imput. Flag TRTEDTM Datetime Last Exposure Treatment TRTETMF Time Last Exposure Imput. Flag TRTDURD Total Treatment Duration (Days) SCRFDT Screen Failure Date EOSDT End Study Date EOSSTT End Study Status FRVDT Final Retrievel Visit Date RANDDT Date Randomization DTHDT Date Death DTHADY Relative Day Death LDDTHELD Elapsed Days Last Dose Death LSTALVDT Date Last Known Alive AGEGR1 Pooled Age Group 1 SAFFL Safety Population Flag RACEGR1 Pooled Race Group 1 REGION1 Geographic Region 1 LDDTHGR1 Last Dose Death - Days Elapsed Grp 1 DTH30FL Death Within 30 Days Last Trt Flag DTHA30FL Death 30 Days Last Trt Flag DTHB30FL Death Within 30 Days First Trt Flag","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advs.html","id":"source","dir":"Reference","previous_headings":"","what":"Source","title":"Vital Signs Analysis — advs","text":"Generated admiral package (template ad_advs.R).","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advs.html","id":"references","dir":"Reference","previous_headings":"","what":"References","title":"Vital Signs Analysis — advs","text":"None","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/advs.html","id":"ref-examples","dir":"Reference","previous_headings":"","what":"Examples","title":"Vital Signs Analysis — advs","text":"","code":"data(\"advs\")"},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/pharmaverseadam-package.html","id":null,"dir":"Reference","previous_headings":"","what":"pharmaverseadam: ADaM Test Data for the 'Pharmaverse' Family of Packages — pharmaverseadam-package","title":"pharmaverseadam: ADaM Test Data for the 'Pharmaverse' Family of Packages — pharmaverseadam-package","text":"set Analysis Data Model (ADaM) datasets constructed using Study Data Tabulation Model (SDTM) datasets contained 'pharmaversesdtm' package template scripts 'admiral' family packages. ADaM dataset specifications described : CDISC Analysis Data Model Team (2021) https://www.cdisc.org/system/files/members/standard/foundational/ADaMIG_v1.3.pdf.","code":""},{"path":[]},{"path":"https://pharmaverse.github.io/pharmaverseadam/reference/pharmaverseadam-package.html","id":"author","dir":"Reference","previous_headings":"","what":"Author","title":"pharmaverseadam: ADaM Test Data for the 'Pharmaverse' Family of Packages — pharmaverseadam-package","text":"Maintainer: Edoardo Mancini edoardo.mancini@roche.com Authors: Kangjie Zhang Stefan Bundfuss Gayatri G Daphne Grassely Zelos Zhu Sadchla Mascary","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/news/index.html","id":"pharmaverseadam-100","dir":"Changelog","previous_headings":"","what":"pharmaverseadam 1.0.0","title":"pharmaverseadam 1.0.0","text":"CRAN release: 2024-07-01","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/news/index.html","id":"documentation-1-0-0","dir":"Changelog","previous_headings":"","what":"Documentation","title":"pharmaverseadam 1.0.0","text":"first stable version pharmaverseadam! Dataset labels updated align ADaM IG (#64) Refreshed pharmaverseadam datasets using admiral 1.1.1, admiralophtha 1.1.0, admiralonco 1.1.0, admiralvaccine 0.2.0. (#58)","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/news/index.html","id":"pharmaverseadam-020","dir":"Changelog","previous_headings":"","what":"pharmaverseadam 0.2.0","title":"pharmaverseadam 0.2.0","text":"CRAN release: 2024-01-08","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/news/index.html","id":"new-features-0-2-0","dir":"Changelog","previous_headings":"","what":"New Features","title":"pharmaverseadam 0.2.0","text":"Variables labels applied datasets metacore/metatools. (#50) ADPC, ADPPK ADPP updated handle urine records. (#57)","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/news/index.html","id":"pharmaverseadam-011","dir":"Changelog","previous_headings":"","what":"pharmaverseadam 0.1.1","title":"pharmaverseadam 0.1.1","text":"CRAN release: 2023-09-20","code":""},{"path":"https://pharmaverse.github.io/pharmaverseadam/news/index.html","id":"new-features-0-1-1","dir":"Changelog","previous_headings":"","what":"New Features","title":"pharmaverseadam 0.1.1","text":"DESCRIPTION file updated ahead CRAN release include references ADaM Implementation Guide 1.3.","code":""},{"path":[]},{"path":"https://pharmaverse.github.io/pharmaverseadam/news/index.html","id":"new-features-0-1-0","dir":"Changelog","previous_headings":"","what":"New Features","title":"pharmaverseadam 0.1.0","text":"Test ADaM data created admiral templates added.","code":""}]