, Kangjie Zhang [aut],
Stefan Bundfuss [aut]
, Gayatri G [aut],
Daphne Grassely [aut], Zelos Zhu [aut], Sadchla Mascary [aut]| Title: | ADaM Test Data for the 'Pharmaverse' Family of Packages |
|---|---|
| Description: | A set of Analysis Data Model (ADaM) datasets constructed using the Study Data Tabulation Model (SDTM) datasets contained in the 'pharmaversesdtm' package and the template scripts from the 'admiral' family of packages. ADaM dataset specifications are described in the CDISC ADaM implementation guide, accessible by creating a free account on <https://www.cdisc.org/>. |
| Authors: | Edoardo Mancini [aut, cre]
, Kangjie Zhang [aut],
Stefan Bundfuss [aut]
, Gayatri G [aut],
Daphne Grassely [aut], Zelos Zhu [aut], Sadchla Mascary [aut] |
| Maintainer: | Edoardo Mancini <[email protected]> |
| License: | Apache License (>= 2) |
| Version: | 1.1.0 |
| Built: | 2024-11-25 06:28:45 UTC |
| Source: | CRAN |
Adverse Events Analysis
adaeadae
A data frame with 105 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Sponsor-Defined Identifier
Reported Term for the Adverse Event
Lowest Level Term
Lowest Level Term Code
Dictionary-Derived Term
Preferred Term Code
High Level Term
High Level Term Code
High Level Group Term
High Level Group Term Code
Body System or Organ Class
Body System or Organ Class Code
Primary System Organ Class
Primary System Organ Class Code
Severity/Intensity
Serious Event
Action Taken with Study Treatment
Causality
Outcome of Adverse Event
Involves Cancer
Congenital Anomaly or Birth Defect
Persist or Signif Disability/Incapacity
Results in Death
Requires or Prolongs Hospitalization
Is Life Threatening
Occurred with Overdose
Date/Time of Collection
Start Date/Time of Adverse Event
End Date/Time of Adverse Event
Study Day of Start of Adverse Event
Study Day of End of Adverse Event
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Date of Death
End of Study Date
Analysis Start Date/Time
Analysis Start Date Imputation Flag
Analysis Start Time Imputation Flag
Analysis End Date/Time
Analysis End Date Imputation Flag
Analysis End Time Imputation Flag
Analysis Start Date
Analysis End Date
Analysis Start Relative Day
Analysis End Relative Day
Analysis Duration (N)
Analysis Duration Units
End Date/Time of Last Dose
Analysis Severity/Intensity
Analysis Causality
Treatment Emergent Analysis Flag
Analysis Severity/Intensity (N)
1st Max Sev./Int. Occurrence Flag
Subject Identifier for the Study
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of Informed Consent
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Study Site Identifier
Age
Age Units
Sex
Race
Ethnicity
Planned Arm Code
Description of Planned Arm
Actual Arm Code
Description of Actual Arm
Country
Date/Time of Collection
Study Day of Collection
Planned Treatment for Period 01
Actual Treatment for Period 01
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
Total Treatment Duration (Days)
Screen Failure Date
End of Study Status
Final Retrievel Visit Date
Date of Randomization
undocumented field
Relative Day of Death
Elapsed Days from Last Dose to Death
undocumented field
undocumented field
undocumented field
Date Last Known Alive
Safety Population Flag
Pooled Race Group 1
Pooled Age Group 1
Geographic Region 1
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Death Within 30 Days of First Trt Flag
Generated from admiral package (template ad_adae.R).
None
data("adae")data("adae")
Best Corrected Visual Acuity Analysis
adbcva_ophthaadbcva_ophtha
A data frame with 120 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Category for Ophthalmic Test or Exam
Subcategory for Ophthalmic Test or Exam
Date/Time of Collection
Visit Name
Visit Number
Planned Study Day of Visit
Numeric Result/Finding in Standard Units
Character Result/Finding in Std Format
Result or Finding in Original Units
Name of Ophthalmic Test or Exam
Short Name of Ophthalmic Test or Exam
Ophthalmic Test or Exam Detail
Laterality
Location Used for the Measurement
Study Day of Visit/Collection/Exam
Method of Test or Examination
Original Units
Standard Units
Completion Status
Planned Time Point Name
Planned Time Point Number
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Actual Treatment for Period 01
Planned Treatment for Period 01
Study Eye Location
Analysis Value
Analysis Value Unit
Derivation Type
Affected Eye
Parameter
Parameter Code
Analysis Value (C)
Analysis Date
Analysis Relative Day
Analysis Timepoint (N)
Analysis Timepoint
Analysis Visit
Analysis Visit (N)
Baseline Type
On Treatment Record Flag
Baseline Record Flag
Analysis Flag 01
Analysis Flag 02
Worst Post Baseline Obs
Baseline Value
Baseline Value (C)
Change from Baseline
Percent Change from Baseline
Analysis Sequence Number
Subject Identifier for the Study
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of Informed Consent
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Study Site Identifier
Age
Age Units
Sex
Race
Ethnicity
Planned Arm Code
Description of Planned Arm
Actual Arm Code
Description of Actual Arm
Country/Region
Date/Time of Collection
Study Day of Collection
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
Total Treatment Duration (Days)
Screen Failure Date
End of Study Date
End of Study Status
Final Retrievel Visit Date
Date of Randomization
Date of Death
undocumented field
Relative Day of Death
Elapsed Days from Last Dose to Death
undocumented field
undocumented field
undocumented field
Date Last Known Alive
Safety Population Flag
Pooled Race Group 1
Pooled Age Group 1
Geographic Region 1
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Death Within 30 Days of First Trt Flag
Analysis Criterion 1
Criterion 1 Evaluation Result Flag
Analysis Criterion 2
Criterion 2 Evaluation Result Flag
Analysis Criterion 3
Criterion 3 Evaluation Result Flag
Analysis Criterion 4
Criterion 4 Evaluation Result Flag
Analysis Criterion 5
Criterion 5 Evaluation Result Flag
Analysis Criterion 6
Criterion 6 Evaluation Result Flag
Analysis Criterion 7
Criterion 7 Evaluation Result Flag
Analysis Criterion 8
Criterion 8 Evaluation Result Flag
Analysis Value Category 1 (N)
Analysis Value Category 1
Generated from admiralophtha package (template ad_adbcva.R).
None
data("adbcva_ophtha")data("adbcva_ophtha")
Clinical Events Analysis for Vaccine
adce_vaccineadce_vaccine
A data frame with 56 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Link ID
Link Group ID
Reported Term for the Clinical Event
Dictionary-Derived Term
Laterality
Location of Event
Category for the Clinical Event
Subcategory for the Clinical Event
Clinical Event Pre-specified
Clinical Event Occurrence
Severity/Intensity
Causality
Outcome of Event
Epoch
Date/Time of Event Collection
Start Date/Time of Clinical Event
End Date/Time of Clinical Event
Duration of Clinical Event
Planned Time Point Name
Planned Time Point Number
Time Point Reference
Date/Time of Reference Time Point
Evaluation Interval Text
Completion Status
Reason Clinical Event Not Collected
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Analysis Start Date
Analysis End Date
Analysis Start Relative Day
Analysis End Relative Day
Period
Period Start Date
Period End Date
Analysis Sub-period Start Relative Day
Analysis Causality
Analysis Severity/Intensity
Analysis Severity/Intensity (N)
Event Occurrence Flag
Analysis Sequence Number
Analysis Duration (N)
Analysis Duration Units
Actual Treatment for Period 01
Planned Treatment for Period 01
Age
Age Units
Sex
Race
Country
Ethnicity
Study Site Identifier
Subject Identifier for the Study
Generated from admiralvaccine package (template ad_adce.R).
None
data("adce_vaccine")data("adce_vaccine")
Concomitant Medications Analysis
adcmadcm
A data frame with 95 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Sponsor-Defined Identifier
Reported Name of Drug, Med, or Therapy
Standardized Medication Name
Indication
Medication Class
Dose per Administration
Dose Units
Dosing Frequency per Interval
Route of Administration
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of Collection
Start Date/Time of Medication
End Date/Time of Medication
Study Day of Start of Medication
Study Day of End of Medication
undocumented field
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Date of Death
End of Study Date
Planned Treatment for Period 01
Actual Treatment for Period 01
Analysis Start Date/Time
Analysis Start Date Imputation Flag
Analysis Start Time Imputation Flag
Analysis End Date/Time
Analysis End Date Imputation Flag
Analysis End Time Imputation Flag
Analysis Start Date
Analysis End Date
Analysis Start Relative Day
Analysis End Relative Day
Analysis Duration (N)
Analysis Duration Units
On Treatment Record Flag
Pre-treatment Flag
Follow-up Flag
Analysis Flag 01
1st Occurrence of Preferred Term Flag
Phase
Description of Phase N
Planned Treatment
Actual Treatment
Subject Identifier for the Study
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of Informed Consent
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Study Site Identifier
Age
Age Units
Sex
Race
Ethnicity
Planned Arm Code
Description of Planned Arm
Actual Arm Code
Description of Actual Arm
Country
Date/Time of Collection
Study Day of Collection
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Datetime of Last Exposure to Treatment
Treatment End Datetime Imput Flag
Total Treatment Duration (Days)
Screen Failure Date
End of Study Status
Final Retrievel Visit Date
Date of Randomization
undocumented field
Relative Day of Death
Elapsed Days from Last Dose to Death
undocumented field
undocumented field
undocumented field
Date Last Known Alive
Safety Population Flag
Pooled Race Group 1
Pooled Age Group 1
Geographic Region 1
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Death Within 30 Days of First Trt Flag
Generated from admiral package (template ad_adcm.R).
None
data("adcm")data("adcm")
Electrocardiogram Tests Analysis
adegadeg
A data frame with 108 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
ECG Test or Examination Short Name
ECG Test or Examination Name
Result or Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Completion Status
Lead Location Used for Measurement
Baseline Flag
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of ECG
Study Day of ECG
Planned Time Point Name
Planned Time Point Number
Planned Elapsed Time from Time Point Ref
Time Point Reference
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Actual Treatment for Period 01
Planned Treatment for Period 01
Analysis Datetime
Analysis Time Imputation Flag
Analysis Relative Day
Parameter Code
Analysis Value
Analysis Value (C)
Analysis Date
Analysis Timepoint (N)
Analysis Timepoint
Analysis Visit
Analysis Visit (N)
Derivation Type
On Treatment Record Flag
Analysis Normal Range Lower Limit
Analysis Normal Range Upper Limit
Analysis Reference Range Indicator
Baseline Type
Baseline Record Flag
Baseline Value
Baseline Value (C)
Baseline Reference Range Indicator
Change from Baseline
Percent Change from Baseline
Analysis Flag 01
Planned Treatment
Actual Treatment
Analysis Sequence Number
Analysis Value Category 1
Analysis Value Category 1 (N)
Change from Baseline Category 1
Change from Baseline Category 1 (N)
Parameter
Parameter (N)
Subject Identifier for the Study
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of Informed Consent
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Study Site Identifier
Age
Age Units
Sex
Race
Ethnicity
Planned Arm Code
Description of Planned Arm
Actual Arm Code
Description of Actual Arm
Country
Date/Time of Collection
Study Day of Collection
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
Total Treatment Duration (Days)
Screen Failure Date
End of Study Date
End of Study Status
Final Retrievel Visit Date
Date of Randomization
Date of Death
undocumented field
Relative Day of Death
Elapsed Days from Last Dose to Death
undocumented field
undocumented field
undocumented field
Date Last Known Alive
Safety Population Flag
Pooled Race Group 1
Pooled Age Group 1
Geographic Region 1
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Death Within 30 Days of First Trt Flag
Generated from admiral package (template ad_adeg.R).
None
data("adeg")data("adeg")
Exposure Analysis
adexadex
A data frame with 92 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Name of Treatment
Dose
Dose Units
Dose Form
Dosing Frequency per Interval
Route of Administration
Visit Number
Visit Name
Planned Study Day of Visit
Start Date/Time of Treatment
End Date/Time of Treatment
Study Day of Start of Treatment
Study Day of End of Treatment
Reason for Dose Adjustment
Planned Dose
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Datetime of Last Exposure to Treatment
Analysis Start Datetime
Analysis Start Date Imputation Flag
Analysis Start Time Imputation Flag
Analysis End Datetime
Analysis End Date Imputation Flag
Analysis End Time Imputation Flag
Analysis Start Relative Day
Analysis End Relative Day
Duration of Treatment (Days)
Analysis Start Date
Analysis End Date
Dose O
PDose O
Parameter Code
Analysis Value
Analysis Value (C)
Parameter Category 1
Parameter
Parameter (N)
Analysis Value Category 1
Analysis Sequence Number
Subject Identifier for the Study
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of Informed Consent
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Study Site Identifier
Age
Age Units
Sex
Race
Ethnicity
Planned Arm Code
Description of Planned Arm
Actual Arm Code
Description of Actual Arm
Country
Date/Time of Collection
Study Day of Collection
Planned Treatment for Period 01
Actual Treatment for Period 01
Time of First Exposure Imput. Flag
Time of Last Exposure Imput. Flag
Date of Last Exposure to Treatment
Total Treatment Duration (Days)
Screen Failure Date
End of Study Date
End of Study Status
Final Retrievel Visit Date
Date of Randomization
Date of Death
undocumented field
Relative Day of Death
Elapsed Days from Last Dose to Death
undocumented field
undocumented field
undocumented field
Date Last Known Alive
Safety Population Flag
Pooled Race Group 1
Pooled Age Group 1
Geographic Region 1
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Death Within 30 Days of First Trt Flag
Generated from admiral package (template ad_adex.R).
None
data("adex")data("adex")
Findings About Clinical Events Analysis
adface_vaccineadface_vaccine
A data frame with 61 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Age
Age Units
Sex
Race
Safety Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Findings About Test Name
Link ID
Link Group ID
Findings About Test Short Name
Parameter Code
Parameter
Parameter (N)
Object of the Observation
Parameter Category 1
Parameter Category 2
Analysis Value (C)
Analysis Value
Completion Status
Reason Not Performed
Evaluator
Epoch
Analysis Date
Analysis Datetime
Evaluation Interval Text
Analysis Relative Day
Analysis Timepoint
Analysis Timepoint (N)
Analysis Timepoint Reference
Dose
Name of Treatment
Start Date/Time of Treatment
End Date/Time of Treatment
Actual Treatment
Planned Treatment
Period
Period Start Date
Period End Date
Result or Finding in Original Units
Planned Treatment for Period 01
Planned Treatment for Period 02
Actual Treatment for Period 01
Actual Treatment for Period 02
Vaccination Date 01
Vaccination Date 02
Event Value Flag
Day Event Value Flag
Analysis Flag 01
Analysis Flag 02
undocumented field
Generated from admiralvaccine package (template ad_adface.R).
None
data("adface_vaccine")data("adface_vaccine")
Immunogenicity Specimen Assessments
adis_vaccineadis_vaccine
A data frame with 102 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Immunogenicity Test/Exam Short Name
Immunogenicity Test or Examination Name
Category for Immunogenicity Test
Results or Findings in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Results/Findings in Std. Units
Standard Units
Completion Status
Reason Not Done
Vendor Name
Specimen Type
Method of Test or Examination
Baseline Flag
Lower Limit of Quantitation
Visit Number
Epoch
Date/Time of Collection
Study Day of Visit/Collection/Exam
Upper Limit of Quantitation
Limit of Detection
Analysis Visit (N)
Analysis Visit
Analysis Timepoint (N)
Analysis Timepoint
Analysis Timepoint Reference
Analysis Date
Subject Reference Start Date/Time
Per-Protocol Population Flag
Analysis Relative Day
Parameter Code
Parameter
Parameter (N)
Parameter Category 1
First Cutoff Value
Second Cutoff Value
Analysis Value
Analysis Value Unit
Pre-vaccination seropositivity status
Pre-vaccination sero status (n)
Derivation Type
Baseline Type
Baseline Value
Baseline Record Flag
Baseline Category 1
Change from Baseline
Ratio to Baseline
Criterion 1 Evaluation Result Flag
Criterion 1 Evaluation Result Flag (N)
Analysis Criterion 1
Period
Period Start Date
Period End Date
Actual Treatment
Planned Treatment
Per-Protocol Record-Level Flag
Subject Identifier for the Study
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of Informed Consent
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Study Site Identifier
Investigator Identifier
Investigator Name
Date/Time of Birth
Age
Age Units
Sex
Race
Ethnicity
Planned Arm Code
Description of Planned Arm
Actual Arm Code
Description of Actual Arm
Country
Date/Time of Collection
Study Day of Collection
Planned Treatment for Period 01
Planned Treatment for Period 02
Actual Treatment for Period 01
Actual Treatment for Period 02
Datetime of First Exposure to Treatment
Datetime of Last Exposure to Treatment
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Safety Population Flag
Pooled Race Group 1
Pooled Age Group 1
Geographic Region 1
Vaccination Date 01
Vaccination Date 02
Period 01 Start Date
Period 01 End Date
Period 02 Start Date
Period 02 End Date
Generated from admiralvaccine package (template ad_adis.R).
None
data("adis_vaccine")data("adis_vaccine")
Laboratory Analysis
adlbadlb
A data frame with 115 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Lab Test or Examination Short Name
Lab Test or Examination Name
Category for Lab Test
Result or Finding in Original Units
Original Units
Reference Range Lower Limit in Orig Unit
Reference Range Upper Limit in Orig Unit
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Reference Range Lower Limit-Std Units
Reference Range Upper Limit-Std Units
Reference Range Indicator
Baseline Flag
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of Specimen Collection
Study Day of Specimen Collection
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Actual Treatment for Period 01
Planned Treatment for Period 01
Analysis Date
Analysis Relative Day
Parameter Code
Parameter
Parameter (N)
Parameter Category 1
Analysis Value
Analysis Value (C)
Analysis Normal Range Lower Limit
Analysis Normal Range Upper Limit
Derivation Type
Analysis Visit
Analysis Visit (N)
On Treatment Record Flag
Analysis Reference Range Indicator
Baseline Type
Baseline Record Flag
Baseline Value
Baseline Value (C)
Baseline Reference Range Indicator
Change from Baseline
Percent Change from Baseline
Analysis Toxicity Description Low
Analysis Toxicity Description High
Analysis Toxicity Grade Low
Analysis Toxicity Grade High
Analysis Toxicity Grade
Baseline Toxicity Grade Low
Baseline Toxicity Grade High
Baseline Toxicity Grade
Ratio to Baseline
Ratio of Analysis Val compared to ANRLO
Ratio of Analysis Val compared to ANRHI
Shift from Baseline to Analysis Value
Shift from Baseline to Overall Grade
Analysis Flag 01
Last Value On Treatment Record Flag
Planned Treatment
Actual Treatment
Analysis Sequence Number
Subject Identifier for the Study
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of Informed Consent
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Study Site Identifier
Age
Age Units
Sex
Race
Ethnicity
Planned Arm Code
Description of Planned Arm
Actual Arm Code
Description of Actual Arm
Country
Date/Time of Collection
Study Day of Collection
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
Total Treatment Duration (Days)
Screen Failure Date
End of Study Date
End of Study Status
Final Retrievel Visit Date
Date of Randomization
Date of Death
undocumented field
Relative Day of Death
Elapsed Days from Last Dose to Death
undocumented field
undocumented field
undocumented field
Date Last Known Alive
Safety Population Flag
Pooled Race Group 1
Pooled Age Group 1
Geographic Region 1
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Death Within 30 Days of First Trt Flag
Generated from admiral package (template ad_adlb.R).
None
data("adlb")data("adlb")
Analysis of Lab Hy's Law
adlbhyadlbhy
A data frame with 14 columns:
Study Identifier
Unique Subject Identifier
Actual Treatment for Period 01
Parameter Code
Sequence Number
Analysis Date
Analysis Visit
Analysis Relative Day
Analysis Value
Analysis Normal Range Upper Limit
Analysis Criterion 1
Criterion 1 Evaluation Result Flag
Analysis Value (C)
Parameter
Generated from admiral package (template ad_adlbhy.R).
None
data("adlbhy")data("adlbhy")
Medical History Analysis
admhadmh
A data frame with 114 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Sponsor-Defined Identifier
Reported Term for the Medical History
Lowest Level Term
Dictionary-Derived Term
High Level Term
High Level Group Term
Category for Medical History
Body System or Organ Class
Severity/Intensity
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of History Collection
Start Date/Time of Medical History Event
Study Day of History Collection
End Date/Time of Medical History Event
Medical History Event Pre-Specified
Medical History Occurrence
Start Relative to Reference Time Point
End Relative to Reference Time Point
Start Reference Time Point
End Reference Time Point
End Relative to Reference Period
Completion Status
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Actual Treatment for Period 01
Planned Treatment for Period 01
Date of Death
End of Study Date
Analysis Start Date
Analysis End Date
Analysis Start Relative Day
Analysis End Relative Day
Analysis Date
Analysis Relative Day
SMQ 02 Name
SMQ 02 Code
SMQ 02 Scope
SMQ 02 Scope (N)
SMQ 03 Name
SMQ 03 Code
SMQ 03 Scope
SMQ 03 Scope (N)
SMQ 05 Name
SMQ 05 Code
SMQ 05 Scope
SMQ 05 Scope (N)
Customized Query 01 Name
Customized Query 04 Name
Customized Query 04 Code
Response of Med Hx (past or current)
1st Occurrence within Subject Flag
1st Occurrence of SOC Flag
1st Occurrence of Preferred Term Flag
1st Occur w/in Trt Prd FL
1st Occur of SOC w/in Trt Prd FL
1st Occur of PT w/in Trt Prd FL
Analysis Flag 01
Planned Treatment
Actual Treatment
Phase
Description of Phase N
Medical History Term (N)
Subject Identifier for the Study
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of Informed Consent
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Study Site Identifier
Age
Age Units
Sex
Race
Ethnicity
Planned Arm Code
Description of Planned Arm
Actual Arm Code
Description of Actual Arm
Country
Date/Time of Collection
Study Day of Collection
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Datetime of Last Exposure to Treatment
Treatment End Datetime Imput Flag
Total Treatment Duration (Days)
Screen Failure Date
End of Study Status
Final Retrievel Visit Date
Date of Randomization
undocumented field
Relative Day of Death
Elapsed Days from Last Dose to Death
undocumented field
undocumented field
undocumented field
Date Last Known Alive
Safety Population Flag
Pooled Race Group 1
Pooled Age Group 1
Geographic Region 1
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Death Within 30 Days of First Trt Flag
Generated from admiral package (template ad_admh.R).
None
data("admh")data("admh")
Exam Analysis for Ophthalmology
adoe_ophthaadoe_ophtha
A data frame with 102 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Category for Ophthalmic Test or Exam
Subcategory for Ophthalmic Test or Exam
Date/Time of Collection
Visit Name
Visit Number
Planned Study Day of Visit
Numeric Result/Finding in Standard Units
Character Result/Finding in Std Format
Result or Finding in Original Units
Name of Ophthalmic Test or Exam
Short Name of Ophthalmic Test or Exam
Ophthalmic Test or Exam Detail
Laterality
Location Used for the Measurement
Study Day of Visit/Collection/Exam
Method of Test or Examination
Original Units
Standard Units
Completion Status
Planned Time Point Name
Planned Time Point Number
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Actual Treatment for Period 01
Planned Treatment for Period 01
Study Eye Location
Analysis Value
Analysis Value (C)
Analysis Value Unit
Derivation Type
Affected Eye
Parameter
Parameter Code
Analysis Date
Analysis Relative Day
Analysis Timepoint (N)
Analysis Timepoint
Analysis Visit
Analysis Visit (N)
Baseline Type
On Treatment Record Flag
Baseline Record Flag
Analysis Flag 01
Analysis Flag 02
Worst Post Baseline Obs
Baseline Value
Baseline Value (C)
Change from Baseline
Percent Change from Baseline
Analysis Sequence Number
Subject Identifier for the Study
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of Informed Consent
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Study Site Identifier
Age
Age Units
Sex
Race
Ethnicity
Planned Arm Code
Description of Planned Arm
Actual Arm Code
Description of Actual Arm
Country
Date/Time of Collection
Study Day of Collection
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
Total Treatment Duration (Days)
Screen Failure Date
End of Study Date
End of Study Status
Final Retrievel Visit Date
Date of Randomization
Date of Death
undocumented field
Relative Day of Death
Elapsed Days from Last Dose to Death
undocumented field
undocumented field
undocumented field
Date Last Known Alive
Safety Population Flag
Pooled Race Group 1
Pooled Age Group 1
Geographic Region 1
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Death Within 30 Days of First Trt Flag
Generated from admiralophtha package (template ad_adoe.R).
None
data("adoe_ophtha")data("adoe_ophtha")
Pharmacokinetic Concentrations
adpcadpc
A data frame with 127 columns:
Study Identifier
Unique Subject Identifier
Nom. Rel. Time from Analyte First Dose
Pharmacokinetic Test Short Name
Pharmacokinetic Test Name
Result or Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Vendor Name
Specimen Material Type
Lower Limit of Quantitation
Visit Name
Visit Number
Date/Time of Specimen Collection
Actual Study Day of Specimen Collection
Planned Time Point Name
Planned Time Point Number
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Planned Treatment for Period 01
Actual Treatment for Period 01
Analysis Datetime
Analysis Time Imputation Flag
Analysis Date
Analysis Time
Analysis Relative Day
First Datetime of Dose for Analyte
Analysis Visit (N)
Analysis Visit
Analysis Start Date
Analysis Start Datetime
Analysis End Date
Analysis End Datetime
Analysis Start Time
Analysis End Time
Act. Rel. Time from Analyte First Dose
Actual Rel. Time from Ref. Dose
Reference Datetime of Dose for Analyte
First Date of Dose for Analyte
First Time of Dose for Analyte
Reference Date of Dose for Analyte
Reference Time of Dose for Analyte
Nominal Rel. Time from Ref. Dose
Parameter Category 1
Analysis Timepoint (N)
Analysis Timepoint
Analysis Timepoint Reference
Baseline Record Flag
Baseline Type
Actual Treatment Dose
Planned Treatment Dose
Treatment Dose Units
Rel. Time from First Dose Unit
Rel. Time from Ref. Dose Unit
Parameter Code
Analysis Lower Limit of Quantitation
Analysis Value
Analysis Value Unit
Analysis Value Category 1
Source Data
Source Variable
Source Sequence Number
Derivation Type
Modified Rel. Time from Ref. Dose
Analysis Flag 01
Analysis Flag 02
Baseline Value
Change from Baseline
Analysis Sequence Number
Parameter
Parameter (N)
Numeric Result/Finding in Standard Units
Standard Units
Numeric Result/Finding in Standard Units
Standard Units
Baseline Body Mass Index (kg/m2)
BMI at Baseline (Unit)
Subject Identifier for the Study
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of Informed Consent
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Study Site Identifier
Age
Age Units
Sex
Race
Ethnicity
Planned Arm Code
Description of Planned Arm
Actual Arm Code
Description of Actual Arm
Country
Date/Time of Collection
Study Day of Collection
Time of First Exposure Imput. Flag
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
Date of Last Exposure to Treatment
Total Treatment Duration (Days)
Screen Failure Date
End of Study Date
End of Study Status
Final Retrievel Visit Date
Date of Randomization
Date of Death
undocumented field
Relative Day of Death
Elapsed Days from Last Dose to Death
undocumented field
undocumented field
undocumented field
Date Last Known Alive
Safety Population Flag
Pooled Race Group 1
Pooled Age Group 1
Geographic Region 1
Last Dose to Death - Days Elapsed Grp 1
Under 30 Group
Over 30 Group
Over 30 plus 30 days Group
Generated from admiral package (template ad_adpc.R).
None
data("adpc")data("adpc")
Pharmacokinetic Parameters
adppadpp
A data frame with 79 columns:
Study Identifier
Unique Subject Identifier
Parameter Short Name
Parameter Name
Parameter Category
Result or Finding in Original Units
Original Units
Standard Units
Specimen Material Type
Date/Time of Reference Point
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Date of Death
End of Study Date
Planned Treatment for Period 01
Actual Treatment for Period 01
Analysis Date
Analysis Relative Day
Parameter Code
Parameter Category
Numeric Result/Finding in Standard Units
Standard Units
Domain Abbreviation
Source Variable
Sequence Number
Analysis Visit (N)
Analysis Visit
Visit Number
Visit Name
Planned Treatment
Actual Treatment
Analysis Value Category 1
Analysis Value Category 1 (N)
Subject Identifier for the Study
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of Informed Consent
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Study Site Identifier
Age
Age Units
Sex
Race
Ethnicity
Planned Arm Code
Description of Planned Arm
Actual Arm Code
Description of Actual Arm
Country
Date/Time of Collection
Study Day of Collection
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
Total Treatment Duration (Days)
Screen Failure Date
End of Study Status
Final Retrievel Visit Date
Date of Randomization
undocumented field
Relative Day of Death
Elapsed Days from Last Dose to Death
undocumented field
undocumented field
undocumented field
Date Last Known Alive
Safety Population Flag
Pooled Race Group 1
Pooled Age Group 1
Geographic Region 1
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Death Within 30 Days of First Trt Flag
Generated from admiral package (template ad_adpp.R).
None
data("adpp")data("adpp")
Population Pharmacokinetic
adppkadppk
A data frame with 61 columns:
Study Identifier
Unique Subject Identifier
Event ID
Nom. Rel. Time from Analyte First Dose
Act. Rel. Time from Analyte First Dose
Actual Rel Time from Previous Dose
Nominal Rel Time from Previous Dose
Actual Treatment Dose
Planned Treatment Dose
Parameter Code
Analysis Lower Limit of Quantitation
Compartment
Below Lower Limit of Quant Flag
Below Lower Limit of Quant Flag (N)
Actual Amount of Dose Received (unit)
Dependent Variable Result
Analysis Value
Log DV
Missing Dependent Variable Result
Analysis Value Unit
Date/Time
Dosing Interval (unit)
Steady State
Analysis Sequence Number
Parameter
Parameter (N)
Project Identifier
Project Identifier (N)
Study Identifier (N)
Study Site Identifier
Study Site Identifier (N)
Unique Subject Identifier (N)
Subject Identifier for the Study
Subject Identifier for the Study (N)
Age
Sex
Sex (N)
Cohort Subject Enrolled Into
Description of Planned Arm
Route of Administration
Route of Administration (N)
Race
Race (N)
Ethnicity
Ethnicity (N)
Drug Formulation
Drug Formulation (N)
Country
Country (N)
Country Name
Numeric Result/Finding in Standard Units
Numeric Result/Finding in Standard Units
Numeric Result/Finding in Standard Units
Numeric Result/Finding in Standard Units
Numeric Result/Finding in Standard Units
Numeric Result/Finding in Standard Units
Baseline Body Mass Index (kg/m2)
Numeric Result/Finding in Standard Units
Baseline Creatinine Clearance
Age
Record Sequence
Generated from admiral package (template ad_adppk.R).
None
data("adppk")data("adppk")
Tumor Response Analysis
adrs_oncoadrs_onco
A data frame with 79 columns:
Domain Abbreviation
Study Identifier
Unique Subject Identifier
Visit Number
Visit Name
Assessment Short Name
Assessment Name
Result or Finding in Original Units
Character Result/Finding in Std Format
Evaluator
Evaluator Identifier
Accepted Record Flag
Date/Time of Assessment
Sequence Number
Date of Randomization
Parameter Code
Parameter
Parameter Category 1
Parameter Category 2
Parameter Category 3
Analysis Date
Analysis Date Imputation Flag
Analysis Visit
Analysis Value (C)
Analysis Value
Analysis Flag 01
Analysis Flag 02
Analysis Sequence Number
Subject Identifier for the Study
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of Informed Consent
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Study Site Identifier
Age
Age Units
Sex
Race
Ethnicity
Planned Arm Code
Description of Planned Arm
Actual Arm Code
Description of Actual Arm
Country
Date/Time of Collection
Study Day of Collection
Planned Treatment for Period 01
Actual Treatment for Period 01
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Total Treatment Duration (Days)
Screen Failure Date
End of Study Date
End of Study Status
Final Retrievel Visit Date
Date of Death
Date of Death Imputation Flag
Relative Day of Death
Elapsed Days from Last Dose to Death
Cause of Death
Domain for Date of Death Collection
Cause of Death Reason 1
Date Last Known Alive
Safety Population Flag
Pooled Race Group 1
Pooled Age Group 1
Geographic Region 1
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Death Within 30 Days of First Trt Flag
Generated from admiralonco package (template ad_adrs.R).
None
data("adrs_onco")data("adrs_onco")
Subject Level Analysis
adsladsl
A data frame with 54 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of Informed Consent
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Study Site Identifier
Age
Age Units
Sex
Race
Ethnicity
Planned Arm Code
Description of Planned Arm
Actual Arm Code
Description of Actual Arm
Country
Date/Time of Collection
Study Day of Collection
Planned Treatment for Period 01
Actual Treatment for Period 01
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Total Treatment Duration (Days)
Screen Failure Date
End of Study Date
End of Study Status
Final Retrievel Visit Date
Date of Randomization
Date of Death
Date of Death Imputation Flag
Relative Day of Death
Elapsed Days from Last Dose to Death
undocumented field
undocumented field
undocumented field
Date Last Known Alive
Safety Population Flag
Pooled Race Group 1
Pooled Age Group 1
Geographic Region 1
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Death Within 30 Days of First Trt Flag
Generated from admiral package (template ad_adsl.R).
None
data("adsl")data("adsl")
Subject Level Analysis for Vaccine
adsl_vaccineadsl_vaccine
A data frame with 46 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of Informed Consent
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Study Site Identifier
Investigator Identifier
Investigator Name
Date/Time of Birth
Age
Age Units
Sex
Race
Ethnicity
Planned Arm Code
Description of Planned Arm
Actual Arm Code
Description of Actual Arm
Country/Region
Date/Time of Collection
Study Day of Collection
Planned Treatment for Period 01
Planned Treatment for Period 02
Actual Treatment for Period 01
Actual Treatment for Period 02
Datetime of First Exposure to Treatment
Datetime of Last Exposure to Treatment
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Safety Population Flag
Per-Protocol Population Flag
Pooled Race Group 1
Pooled Age Group 1
Geographic Region 1
Vaccination Date 01
Vaccination Date 02
Period 01 Start Date
Period 01 End Date
Period 02 Start Date
Period 02 End Date
Generated from admiralvaccine package (template ad_adsl.R).
None
data("adsl_vaccine")data("adsl_vaccine")
Tumor Results Analysis for Oncology
adtr_oncoadtr_onco
A data frame with 99 columns:
Domain Abbreviation
Study Identifier
Unique Subject Identifier
Group ID
Link ID
Tumor/Lesion Assessment Short Name
Tumor/Lesion Assessment Test Name
Result or Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Visit Number
Visit Name
Evaluator
Evaluator Identifier
Accepted Record Flag
Date/Time of Tumor/Lesion Measurement
Sequence Number
Date of Randomization
Location of the Tumor/Lesion
Tumor Site Group 1
Lesion IDs Expected
Lesion IDs Assessed
Analysis Date
Analysis Date Imputation Flag
Analysis Relative Day
Analysis Visit
Analysis Visit (N)
Parameter Code
Parameter
Parameter Category 1
Parameter Category 2
Parameter Category 3
Analysis Value
Analysis Flag 01
Baseline Record Flag
Baseline Value
NADIR
Change from Baseline
Percent Change from Baseline
Change from NADIR
Percent Change from NADIR
Pharmacodynamic Analysis Set Flag
Analysis Flag 02
Analysis Flag 03
Analysis Flag 04
Analysis Sequence Number
Subject Identifier for the Study
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of Informed Consent
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Study Site Identifier
Age
Age Units
Sex
Race
Ethnicity
Planned Arm Code
Description of Planned Arm
Actual Arm Code
Description of Actual Arm
Country
Date/Time of Collection
Study Day of Collection
Planned Treatment for Period 01
Actual Treatment for Period 01
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Total Treatment Duration (Days)
Screen Failure Date
End of Study Date
End of Study Status
Final Retrievel Visit Date
Date of Death
Date of Death Imputation Flag
Relative Day of Death
Elapsed Days from Last Dose to Death
Cause of Death
Domain for Date of Death Collection
Cause of Death Reason 1
Date Last Known Alive
Safety Population Flag
Pooled Race Group 1
Pooled Age Group 1
Geographic Region 1
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Death Within 30 Days of First Trt Flag
Generated from admiralonco package (template ad_adtr.R).
None
data("adtr_onco")data("adtr_onco")
Time to Event Analysis for Oncology
adtte_oncoadtte_onco
A data frame with 20 columns:
Study Identifier
Unique Subject Identifier
Analysis Date
Event or Censoring Description
Source Data
Source Variable
Source Sequence Number
Censor
Censor Date Description
Time-to-Event Origin Date for Subject
Parameter Code
Parameter
Analysis Value
Analysis Sequence Number
Planned Arm Code
Description of Planned Arm
Actual Arm Code
Description of Actual Arm
Age
Sex
Generated from admiralonco package (template ad_adtte.R).
None
data("adtte_onco")data("adtte_onco")
Visual Function Questionnaire Analysis
advfq_ophthaadvfq_ophtha
A data frame with 89 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Question Short Name
Question Name
Category of Question
Subcategory for Question
Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Finding in Standard Units
Standard Units
Baseline Flag
Derived Flag
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of Finding
Study Day of Finding
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Actual Treatment for Period 01
Planned Treatment for Period 01
Analysis Date
Analysis Relative Day
Parameter Code
Analysis Value
Analysis Value (C)
Analysis Visit
Analysis Visit (N)
On Treatment Record Flag
Baseline Record Flag
Baseline Value
Change from Baseline
Percent Change from Baseline
Analysis Flag 01
Analysis Sequence Number
Parameter
Parameter Category 1
Parameter Category 2
Subject Identifier for the Study
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of Informed Consent
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Study Site Identifier
Age
Age Units
Sex
Race
Ethnicity
Planned Arm Code
Description of Planned Arm
Actual Arm Code
Description of Actual Arm
Country
Date/Time of Collection
Study Day of Collection
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
Total Treatment Duration (Days)
Screen Failure Date
End of Study Date
End of Study Status
Final Retrievel Visit Date
Date of Randomization
Date of Death
undocumented field
Relative Day of Death
Elapsed Days from Last Dose to Death
undocumented field
undocumented field
undocumented field
Date Last Known Alive
Safety Population Flag
Pooled Race Group 1
Pooled Age Group 1
Geographic Region 1
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Death Within 30 Days of First Trt Flag
Generated from admiralophtha package (template ad_advfq.R).
None
data("advfq_ophtha")data("advfq_ophtha")
Vital Signs Analysis
advsadvs
A data frame with 105 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Vital Signs Test Short Name
Vital Signs Test Name
Vital Signs Position of Subject
Result or Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Completion Status
Location of Vital Signs Measurement
Baseline Flag
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of Measurements
Study Day of Vital Signs
Planned Time Point Name
Planned Time Point Number
Planned Elapsed Time from Time Point Ref
Time Point Reference
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Actual Treatment for Period 01
Planned Treatment for Period 01
Analysis Date
Analysis Relative Day
Parameter Code
Analysis Value
Analysis Timepoint (N)
Analysis Timepoint
Analysis Visit
Analysis Visit (N)
Derivation Type
On Treatment Record Flag
Analysis Normal Range Lower Limit
Analysis Normal Range Upper Limit
Analysis Range 1 Lower Limit
Analysis Range 1 Upper Limit
Analysis Reference Range Indicator
Baseline Type
Baseline Record Flag
Baseline Value
Baseline Reference Range Indicator
Change from Baseline
Percent Change from Baseline
Analysis Flag 01
Planned Treatment
Actual Treatment
Analysis Sequence Number
Analysis Value Category 1
Analysis Value Category 1 (N)
Parameter
Parameter (N)
Subject Identifier for the Study
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of Informed Consent
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Study Site Identifier
Age
Age Units
Sex
Race
Ethnicity
Planned Arm Code
Description of Planned Arm
Actual Arm Code
Description of Actual Arm
Country
Date/Time of Collection
Study Day of Collection
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
Total Treatment Duration (Days)
Screen Failure Date
End of Study Date
End of Study Status
Final Retrievel Visit Date
Date of Randomization
Date of Death
undocumented field
Relative Day of Death
Elapsed Days from Last Dose to Death
undocumented field
undocumented field
undocumented field
Date Last Known Alive
Safety Population Flag
Pooled Race Group 1
Pooled Age Group 1
Geographic Region 1
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Death Within 30 Days of First Trt Flag
Generated from admiral package (template ad_advs.R).
None
data("advs")data("advs")
Vital Signs Analysis for Pediatrics
advs_pedsadvs_peds
A data frame with 80 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Vital Signs Test Short Name
Vital Signs Test Name
Vital Signs Position of Subject
Result or Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Completion Status
Location of Vital Signs Measurement
Baseline Flag
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of Measurements
Study Day of Vital Signs
Planned Time Point Name
Planned Time Point Number
Planned Elapsed Time from Time Point Ref
Time Point Reference
Evaluator
Epoch
Sex
Date/Time of Birth (Character)
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Actual Treatment for Period 01
Planned Treatment for Period 01
Date/Time of Birth
Analysis Date
Analysis Relative Day
Current Analysis Age (Days)
Current Analysis Age Units
Parameter Code
Analysis Value
Analysis Timepoint (N)
Analysis Timepoint
Analysis Visit
Analysis Visit (N)
Temporary Height at Timepoint
Temporary Height at Timepoint Units
Parameter
Parameter (N)
Baseline Record Flag
Baseline Value
Change from Baseline
Percent Change from Baseline
On Treatment Record Flag
Analysis Flag 01
Subject Identifier for the Study
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of Informed Consent
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Study Site Identifier
Age
Age Units
Race
Ethnicity
Planned Arm Code
Description of Planned Arm
Actual Arm Code
Description of Actual Arm
Country
Date/Time of Collection
Study Day of Collection
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
Total Treatment Duration (Days)
Analysis Sequence Number
Generated from admiralpeds package (template ad_advs.R).
None
data("advs_peds")data("advs_peds")