| Type: | Package |
| Title: | SDTM Test Data for the 'Pharmaverse' Family of Packages |
| Version: | 1.3.1 |
| Description: | A set of Study Data Tabulation Model (SDTM) datasets from the Clinical Data Interchange Standards Consortium (CDISC) pilot project used for testing and developing Analysis Data Model (ADaM) datasets inside the pharmaverse family of packages. SDTM dataset specifications are described in the CDISC SDTM implementation guide, accessible by creating a free account on https://www.cdisc.org/. |
| License: | Apache License (≥ 2.0) |
| URL: | https://pharmaverse.github.io/pharmaversesdtm/, https://github.com/pharmaverse/pharmaversesdtm/ |
| Depends: | R (≥ 3.5.0) |
| Suggests: | covr, devtools, knitr, lintr, metatools, pkgdown, rmarkdown, roxygen2, spelling, testthat, usethis |
| Encoding: | UTF-8 |
| Language: | en-US |
| LazyData: | true |
| RoxygenNote: | 7.3.2 |
| NeedsCompilation: | no |
| Packaged: | 2025-08-21 08:36:51 UTC; lina.patil |
| Author: | Lina Patil [aut, cre],
Stefan Bundfuss 
[aut],
Fanny Gautier
[aut],
Edoardo Mancini
[aut],
Tomoyuki Namai [aut],
Vinh Nguyen [aut],
Vladyslav Shuliar
[aut],
Cytel Inc. [cph, fnd],
F. Hoffmann-La Roche AG [cph, fnd],
GlaxoSmithKline LLC [cph, fnd] |
| Maintainer: | Lina Patil <lina.patil@cytel.com> |
| Repository: | CRAN |
| Date/Publication: | 2025-08-21 09:20:02 UTC |
pharmaversesdtm: SDTM Test Data for the 'Pharmaverse' Family of Packages
Description
A set of Study Data Tabulation Model (SDTM) datasets from the Clinical Data Interchange Standards Consortium (CDISC) pilot project used for testing and developing Analysis Data Model (ADaM) datasets inside the pharmaverse family of packages. SDTM dataset specifications are described in the CDISC SDTM implementation guide, accessible by creating a free account on https://www.cdisc.org/.
Author(s)
Maintainer: Lina Patil lina.patil@cytel.com
Authors:
Stefan Bundfuss (ORCID)
Fanny Gautier fanny.gautier@cytel.com (ORCID)
Edoardo Mancini edoardo.mancini@roche.com (ORCID)
Tomoyuki Namai
Vinh Nguyen
Vladyslav Shuliar (ORCID)
Other contributors:
Cytel Inc. [copyright holder, funder]
F. Hoffmann-La Roche AG [copyright holder, funder]
GlaxoSmithKline LLC [copyright holder, funder]
See Also
Useful links:
Adverse Events
Description
An updated SDTM AE dataset that uses the CDISC pilot project
Usage
ae
Format
A data frame with 35 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- AESEQ
Sequence Number
- AESPID
Sponsor-Defined Identifier
- AETERM
Reported Term for the Adverse Event
- AELLT
Lowest Level Term
- AELLTCD
Lowest Level Term Code
- AEDECOD
Dictionary-Derived Term
- AEPTCD
Preferred Term Code
- AEHLT
High Level Term
- AEHLTCD
High Level Term Code
- AEHLGT
High Level Group Term
- AEHLGTCD
High Level Group Term Code
- AEBODSYS
Body System or Organ Class
- AEBDSYCD
Body System or Organ Class Code
- AESOC
Primary System Organ Class
- AESOCCD
Primary System Organ Class Code
- AESEV
Severity/Intensity
- AESER
Serious Event
- AEACN
Action Taken with Study Treatment
- AEREL
Causality
- AEOUT
Outcome of Adverse Event
- AESCAN
Involves Cancer
- AESCONG
Congenital Anomaly or Birth Defect
- AESDISAB
Persist or Signif Disability/Incapacity
- AESDTH
Results in Death
- AESHOSP
Requires or Prolongs Hospitalization
- AESLIFE
Is Life Threatening
- AESOD
Occurred with Overdose
- AEDTC
Date/Time of Collection
- AESTDTC
Start Date/Time of Adverse Event
- AEENDTC
End Date/Time of Adverse Event
- AESTDY
Study Day of Start of Adverse Event
- AEENDY
Study Day of End of Adverse Event
Details
Adverse Events
An updated SDTM AE dataset that uses the CDISC pilot project
Author(s)
Gopi Vegesna
Source
Access the source of the Adverse Events dataset.
Adverse Events for Ophthalmology
Description
An example Adverse Events SDTM dataset with ophthalmology-specific variable AELAT
Usage
ae_ophtha
Format
A data frame with 37 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- AESEQ
Sequence Number
- AESPID
Sponsor-Defined Identifier
- AETERM
Reported Term for the Adverse Event
- AELLT
Lowest Level Term
- AELLTCD
Lowest Level Term Code
- AEDECOD
Dictionary-Derived Term
- AEPTCD
Preferred Term Code
- AEHLT
High Level Term
- AEHLTCD
High Level Term Code
- AEHLGT
High Level Group Term
- AEHLGTCD
High Level Group Term Code
- AEBODSYS
Body System or Organ Class
- AEBDSYCD
Body System or Organ Class Code
- AESOC
Primary System Organ Class
- AESOCCD
Primary System Organ Class Code
- AESEV
Severity/Intensity
- AESER
Serious Event
- AEACN
Action Taken with Study Treatment
- AEREL
Causality
- AEOUT
Outcome of Adverse Event
- AESCAN
Involves Cancer
- AESCONG
Congenital Anomaly or Birth Defect
- AESDISAB
Persist or Signif Disability/Incapacity
- AESDTH
Results in Death
- AESHOSP
Requires or Prolongs Hospitalization
- AESLIFE
Is Life Threatening
- AESOD
Occurred with Overdose
- AEDTC
Date/Time of Collection
- AESTDTC
Start Date/Time of Adverse Event
- AEENDTC
End Date/Time of Adverse Event
- AESTDY
Study Day of Start of Adverse Event
- AEENDY
Study Day of End of Adverse Event
- AELAT
Laterality
- AELOC
Location
Details
Adverse Events for Ophthalmology
An example Adverse Events SDTM dataset with ophthalmology-specific variable AELAT
Source
Constructed using ae from the pharmaversesdtm package
Clinical Events for Vaccine
Description
An example SDTM CE dataset for vaccine studies
Usage
ce_vaccine
Format
A data frame with 29 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- CESEQ
Sequence Number
- CELNKID
Link ID
- CELNKGRP
Link Group ID
- CETERM
Reported Term for the Clinical Event
- CEDECOD
Dictionary-Derived Term
- CELAT
Laterality of Location of Clinical Event
- CELOC
Location of Clinical Event
- CECAT
Category for Clinical Event
- CESCAT
Subcategory for Clinical Event
- CEPRESP
Clinical Event Pre-Specified
- CEOCCUR
Clinical Event Occurrence
- CESEV
Severity/Intensity
- CEREL
Causality
- CEOUT
Outcome of Clinical Event
- EPOCH
Epoch
- CEDTC
Date/Time of Event Collection
- CESTDTC
Start Date/Time of Clinical Event
- CEENDTC
End Date/Time of Clinical Event
- CEDUR
Duration of Clinical Event
- CETPT
Planned Time Point Name
- CETPTNUM
Planned Time Point Number
- CETPTREF
Time Point Reference
- CERFTDTC
Date/Time of Reference Time Point
- CEEVINTX
Evaluation Interval Text
- CESTAT
Completion Status
- CEREASND
Reason Clinical Event Not Collected
Details
Clinical Events for Vaccine
An example SDTM CE dataset for vaccine studies
Source
Constructed by admiralvaccine developers
Concomitant Medication
Description
A SDTM CM dataset from the CDISC pilot project
Usage
cm
Format
A data frame with 22 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- CMSEQ
Sequence Number
- CMSPID
Sponsor-Defined Identifier
- CMTRT
Reported Name of Drug, Med, or Therapy
- CMDECOD
Standardized Medication Name
- CMINDC
Indication
- CMCLAS
Medication Class
- CMDOSE
Dose per Administration
- CMDOSU
Dose Units
- CMDOSFRQ
Dosing Frequency per Interval
- CMROUTE
Route of Administration
- VISITNUM
Visit Number
- VISIT
Visit Name
- VISITDY
Planned Study Day of Visit
- CMDTC
Date/Time of Collection
- CMSTDTC
Start Date/Time of Medication
- CMENDTC
End Date/Time of Medication
- CMSTDY
Study Day of Start of Medication
- CMENDY
Study Day of End of Medication
- CMENRTPT
End Relative to Reference Time Point
Details
Concomitant Medication
A SDTM CM dataset from the CDISC pilot project
Source
Access the source of the Concomitant Medication dataset.
Demography
Description
A SDTM DM dataset from the CDISC pilot project
Usage
dm
Format
A data frame with 25 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- SUBJID
Subject Identifier for the Study
- RFSTDTC
Subject Reference Start Date/Time
- RFENDTC
Subject Reference End Date/Time
- RFXSTDTC
Date/Time of First Study Treatment
- RFXENDTC
Date/Time of Last Study Treatment
- RFICDTC
Date/Time of Informed Consent
- RFPENDTC
Date/Time of End of Participation
- DTHDTC
Date/Time of Death
- DTHFL
Subject Death Flag
- SITEID
Study Site Identifier
- AGE
Age
- AGEU
Age Units
- SEX
Sex
- RACE
Race
- ETHNIC
Ethnicity
- ARMCD
Planned Arm Code
- ARM
Description of Planned Arm
- ACTARMCD
Actual Arm Code
- ACTARM
Description of Actual Arm
- COUNTRY
Country
- DMDTC
Date/Time of Collection
- DMDY
Study Day of Collection
Details
Demography
A SDTM DM dataset from the CDISC pilot project
Source
Access the source of the Demography dataset.
Demographic Dataset-metabolic
Description
A SDTM DM dataset for metabolic studies
Usage
dm_metabolic
Format
A data frame with 25 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- SUBJID
Subject Identifier for the Study
- RFSTDTC
Subject Reference Start Date/Time
- RFENDTC
Subject Reference End Date/Time
- RFXSTDTC
Date/Time of First Study Treatment
- RFXENDTC
Date/Time of Last Study Treatment
- RFICDTC
Date/Time of Informed Consent
- RFPENDTC
Date/Time of End of Participation
- DTHDTC
Date/Time of Death
- DTHFL
Subject Death Flag
- SITEID
Study Site Identifier
- AGE
Age
- AGEU
Age Units
- SEX
Sex
- RACE
Race
- ETHNIC
Ethnicity
- ARMCD
Planned Arm Code
- ARM
Description of Planned Arm
- ACTARMCD
Actual Arm Code
- ACTARM
Description of Actual Arm
- COUNTRY
Country
- DMDTC
Date/Time of Collection
- DMDY
Study Day of Collection
Details
Demographic Dataset-metabolic
A SDTM DM dataset for metabolic studies
Source
Constructed by admiralmetabolic developers
Demographic Dataset-pediatrics
Description
An updated SDTM DM dataset with pediatric patients
Usage
dm_peds
Format
A data frame with 26 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- SUBJID
Subject Identifier for the Study
- RFSTDTC
Subject Reference Start Date/Time
- RFENDTC
Subject Reference End Date/Time
- RFXSTDTC
Date/Time of First Study Treatment
- RFXENDTC
Date/Time of Last Study Treatment
- RFICDTC
Date/Time of Informed Consent
- RFPENDTC
Date/Time of End of Participation
- DTHDTC
Date/Time of Death
- DTHFL
Subject Death Flag
- SITEID
Study Site Identifier
- AGE
Age
- AGEU
Age Units
- SEX
Sex
- RACE
Race
- ETHNIC
Ethnicity
- ARMCD
Planned Arm Code
- ARM
Description of Planned Arm
- ACTARMCD
Actual Arm Code
- ACTARM
Description of Actual Arm
- COUNTRY
Country
- DMDTC
Date/Time of Collection
- DMDY
Study Day of Collection
- BRTHDTC
Date/Time of Birth
Details
Demographic Dataset-pediatrics
An updated SDTM DM dataset with pediatric patients
Source
Constructed by admiralpeds developers
Demographics for Vaccine
Description
An example SDTM DM dataset for vaccine studies
Usage
dm_vaccine
Format
A data frame with 28 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- SUBJID
Subject Identifier for the Study
- RFSTDTC
Subject Reference Start Date/Time
- RFENDTC
Subject Reference End Date/Time
- RFXSTDTC
Date/Time of First Study Treatment
- RFXENDTC
Date/Time of Last Study Treatment
- RFICDTC
Date/Time of Informed Consent
- RFPENDTC
Date/Time of End of Participation
- DTHDTC
Date/Time of Death
- DTHFL
Subject Death Flag
- SITEID
Study Site Identifier
- INVID
Investigator Identifier
- INVNAM
Investigator Name
- BRTHDTC
Date/Time of Birth
- AGE
Age
- AGEU
Age Units
- SEX
Sex
- RACE
Race
- ETHNIC
Ethnicity
- ARMCD
Planned Arm Code
- ARM
Description of Planned Arm
- ACTARMCD
Actual Arm Code
- ACTARM
Description of Actual Arm
- COUNTRY
Country
- DMDTC
Date/Time of Collection
- DMDY
Study Day of Collection
Details
Demographics for Vaccine
An example SDTM DM dataset for vaccine studies
Source
Constructed by admiralvaccine developers
Disposition
Description
An updated SDTM DS dataset that uses the CDISC pilot project
Usage
ds
Format
A data frame with 13 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- DSSEQ
Sequence Number
- DSSPID
Sponsor-Defined Identifier
- DSTERM
Reported Term for the Disposition Event
- DSDECOD
Standardized Disposition Term
- DSCAT
Category for Disposition Event
- VISITNUM
Visit Number
- VISIT
Visit Name
- DSDTC
Date/Time of Collection
- DSSTDTC
Start Date/Time of Disposition Event
- DSSTDY
Study Day of Start of Disposition Event
Details
Disposition
An updated SDTM DS dataset that uses the CDISC pilot project
Author(s)
Gopi Vegesna
Source
Access the source of the Disposition dataset.
Electrocardiogram
Description
An example of standard SDTM EG dataset to be used in deriving ADEG dataset
Usage
eg
Format
A data frame with 23 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- EGSEQ
Sequence Number
- EGTESTCD
ECG Test Short Name
- EGTEST
ECG Test Name
- EGORRES
Result or Finding in Original Units
- EGORRESU
Original Units
- EGSTRESC
Character Result/Finding in Std Format
- EGSTRESN
Numeric Result/Finding in Standard Units
- EGSTRESU
Standard Units
- EGSTAT
Completion Status
- EGLOC
Location of Vital Signs Measurement
- EGBLFL
Baseline Flag
- VISITNUM
Visit Number
- VISIT
Visit Name
- VISITDY
Planned Study Day of Visit
- EGDTC
Date/Time of Measurements
- EGDY
Study Day of Vital Signs
- EGTPT
Planned Time Point Number
- EGTPTNUM
Time Point Number
- EGELTM
Planned Elapsed Time from Time Point Ref
- EGTPTREF
Time Point Reference
Details
Electrocardiogram
An example of standard SDTM EG dataset to be used in deriving ADEG dataset
Contains a set of 4 unique Test Short Names and Test Names:
| EGTESTCD | EGTEST |
| ECGINT | ECG Interpretation |
| HR | Heart Rate |
| QT | QT Duration |
| RR | RR Duration |
Source
Generated dataset.
Exposure
Description
A SDTM EX dataset from the CDISC pilot project
Usage
ex
Format
A data frame with 17 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- EXSEQ
Sequence Number
- EXTRT
Name of Actual Treatment
- EXDOSE
Dose per Administration
- EXDOSU
Dose Units
- EXDOSFRM
Dose Form
- EXDOSFRQ
Dosing Frequency per Interval
- EXROUTE
Route of Administration
- VISITNUM
Visit Number
- VISIT
Visit Name
- VISITDY
Planned Study Day of Visit
- EXSTDTC
Start Date/Time of Treatment
- EXENDTC
End Date/Time of Treatment
- EXSTDY
Study Day of Start of Treatment
- EXENDY
Study Day of End of Treatment
Details
Exposure
A SDTM EX dataset from the CDISC pilot project
Source
Access the source of the Exposure dataset.
Exposure for Ophthalmology
Description
An example Exposure SDTM dataset with ophthalmology-specific variables such as EXLOC and EXLAT
Usage
ex_ophtha
Format
A data frame with 19 columns:
- USUBJID
Unique Subject Identifier
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- EXSEQ
Sequence Number
- EXTRT
Name of Actual Treatment
- EXDOSE
Dose per Administration
- EXDOSU
Dose Units
- EXDOSFRM
Dose Form
- EXDOSFRQ
Dose Frequency per Interval
- EXROUTE
Route of Administration
- EXLOC
Location of Dose Administration
- EXLAT
Laterality
- VISITNUM
Visit Number
- VISIT
Visit Name
- VISITDY
Planned Study Day of Visit
- EXSTDTC
Start Date/Time of Treatment
- EXENDTC
End Date/Time of Treatment
- EXSTDY
Study Day of Start of Treatment
- EXENDY
Study Day of End of Treatment
Details
Exposure for Ophthalmology
An example Exposure SDTM dataset with ophthalmology-specific variables such as EXLOC and EXLAT
Source
Constructed using ex from the pharmaversesdtm package
Exposures for Vaccine
Description
An example SDTM EX dataset for vaccine studies
Usage
ex_vaccine
Format
A data frame with 19 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- EXSEQ
Sequence Number
- EXLNKGRP
Link Group ID
- EXLNKID
Link ID
- EXTRT
Name of Actual Treatment
- EXCAT
Category of Treatment
- EXDOSE
Dose per Administration
- EXDOSU
Dose Units
- EXDOSFRM
Dose Form
- EXROUTE
Route of Administration
- EXLOC
Location of Dose Administration
- EXLAT
Laterality
- VISITNUM
Visit Number
- VISIT
Visit Name
- EPOCH
Epoch
- EXSTDTC
Start Date/Time of Treatment
- EXENDTC
End Date/Time of Treatment
Details
Exposures for Vaccine
An example SDTM EX dataset for vaccine studies
Source
Constructed by admiralvaccine developers
Findings About Clinical Events for Vaccine
Description
An example SDTM FACE for vaccine studies
Usage
face_vaccine
Format
A data frame with 30 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- FASEQ
Sequence Number
- FALNKGRP
Link Group ID
- FALAT
Laterality
- FALNKID
Link ID
- FALOC
Location of the Finding About
- FATESTCD
Findings About Test Short Name
- FATEST
Findings About Test Name
- FAOBJ
Object of the Observation
- FACAT
Category for Findings About
- FASCAT
Subcategory for Findings About
- FAEVAL
Evaluator
- FAORRES
Result or Finding in Original Units
- FAORRESU
Original Units
- EPOCH
Epoch
- FADTC
Date/Time of Collection
- FADY
Study Day of Collection
- FATPT
Planned Time Point Name
- FATPTNUM
Planned Time Point Number
- FATPTREF
Time Point Reference
- FARFTDTC
Date/Time of Reference Time Point
- FAEVLINT
Evaluation Interval
- FAEVINTX
Evaluation Interval Text
- FASTAT
Completion Status
- FAREASND
Reason Not Performed
- FASTRESC
Character Result/Finding in Std Format
- FASTRESN
Numeric Result/Finding in Standard Units
- FASTRESU
Standard Units
Details
Findings About Clinical Events for Vaccine
An example SDTM FACE for vaccine studies
Contains a set of 3 unique Test Short Names and Test Names:
| FATESTCD | FATEST |
| DIAMETER | Diameter |
| OCCUR | Occurrence Indicator |
| SEV | Severity/Intensity |
Source
Constructed by admiralvaccine developers
An example function as expected by the get_terms_fun parameter of
admiral::create_query_data()
Description
An example function as expected by the get_terms_fun parameter of
admiral::create_query_data()
Usage
get_terms(basket_select, version, keep_id, temp_env)
Arguments
basket_select |
A basket_select object defining the terms |
version |
MedDRA version |
keep_id |
Should |
temp_env |
Temporary environment |
Immunogenicity Specimen Assessments for Vaccine
Description
An example SDTM IS for vaccine studies
Usage
is_vaccine
Format
A data frame with 24 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- ISSEQ
Sequence Number
- ISTESTCD
Immunogenicity Test/Exam Short Name
- ISTEST
Immunogenicity Test or Exam Name
- ISCAT
Category for Immunogenicity Test
- ISORRES
Result or Finding in Original Units
- ISORRESU
Original Units
- ISSTRESC
Character Result/Finding in Std Format
- ISSTRESN
Numeric Result/Finding in Standard Units
- ISSTRESU
Standard Units
- ISSTAT
Completion Status
- ISREASND
Reason Not Done
- ISNAM
Vendor Name
- ISSPEC
Specimen Type
- ISMETHOD
Method of Test or Examination
- ISBLFL
Baseline Flag
- ISLLOQ
Lower Limit of Quantitation
- VISITNUM
Visit Number
- EPOCH
Epoch
- ISDTC
Date/Time of Collection
- ISDY
Study Day of Collection
- ISULOQ
Upper Limit of Quantitation
Details
Immunogenicity Specimen Assessments for Vaccine
An example SDTM IS for vaccine studies
Contains a set of 4 unique Test Short Names and Test Names:
| ISTESTCD | ISTEST |
| I0019NT | I0019NT Antibody |
| J0033VN | J0033VN Antibody |
| M0019LN | M0019LN Antibody |
| R0003MA | R0003MA Antibody |
Source
Constructed by admiralvaccine developers
Laboratory Measurements
Description
An updated SDTM LB dataset that uses data from the CDISC pilot project
Usage
lb
Format
A data frame with 23 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- LBSEQ
Sequence Number
- LBTESTCD
Lab Test or Examination Short Name
- LBTEST
Lab Test or Examination Name
- LBCAT
Category for Lab Test
- LBORRES
Result or Finding in Original Units
- LBORRESU
Original Units
- LBORNRLO
Reference Range Lower Limit in Orig Unit
- LBORNRHI
Reference Range Upper Limit in Orig Unit
- LBSTRESC
Character Result/Finding in Std Format
- LBSTRESN
Numeric Result/Finding in Standard Units
- LBSTRESU
Standard Units
- LBSTNRLO
Reference Range Lower Limit-Std Units
- LBSTNRHI
Reference Range Upper Limit-Std Units
- LBNRIND
Reference Range Indicator
- LBBLFL
Baseline Flag
- VISITNUM
Visit Number
- VISIT
Visit Name
- VISITDY
Planned Study Day of Visit
- LBDTC
Date/Time of Specimen Collection
- LBDY
Study Day of Specimen Collection
Details
Laboratory Measurements
An updated SDTM LB dataset that uses data from the CDISC pilot project
Contains a set of 47 unique Test Short Names and Test Names:
| LBTESTCD | LBTEST |
| ALB | Albumin |
| ALP | Alkaline Phosphatase |
| ALT | Alanine Aminotransferase |
| ANISO | Anisocytes |
| AST | Aspartate Aminotransferase |
| BASO | Basophils |
| BASOLE | Basophils/Leukocytes |
| BILI | Bilirubin |
| BUN | Blood Urea Nitrogen |
| CA | Calcium |
| CHOL | Cholesterol |
| CK | Creatine Kinase |
| CL | Chloride |
| COLOR | Color |
| CREAT | Creatinine |
| EOS | Eosinophils |
| EOSLE | Eosinophils/Leukocytes |
| GGT | Gamma Glutamyl Transferase |
| GLUC | Glucose |
| HBA1C | Hemoglobin A1C |
| HCT | Hematocrit |
| HGB | Hemoglobin |
| K | Potassium |
| KETONES | Ketones |
| LYM | Lymphocytes |
| LYMLE | Lymphocytes/Leukocytes |
| MACROCY | Macrocytes |
| MCH | Ery. Mean Corpuscular Hemoglobin |
| MCHC | Ery. Mean Corpuscular HGB Concentration |
| MCV | Ery. Mean Corpuscular Volume |
| MICROCY | Microcytes |
| MONO | Monocytes |
| MONOLE | Monocytes/Leukocytes |
| PH | pH |
| PHOS | Phosphate |
| PLAT | Platelet |
| POIKILO | Poikilocytes |
| POLYCHR | Polychromasia |
| PROT | Protein |
| RBC | Erythrocytes |
| SODIUM | Sodium |
| SPGRAV | Specific Gravity |
| TSH | Thyrotropin |
| URATE | Urate |
| UROBIL | Urobilinogen |
| VITB12 | Vitamin B12 |
| WBC | Leukocytes |
Author(s)
Annie Yang
Source
Access the source of the Laboratory Measurements dataset.
Laboratory Measurements Dataset-metabolic
Description
A SDTM LB dataset containing relevant laboratory measurements for metabolic studies
Usage
lb_metabolic
Format
A data frame with 24 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- LBSEQ
Sequence Number
- LBTESTCD
Lab Test or Examination Short Name
- LBTEST
Lab Test or Examination Name
- LBCAT
Category for Lab Test
- LBORRES
Result or Finding in Original Units
- LBORRESU
Original Units
- LBORNRLO
Reference Range Lower Limit in Orig Unit
- LBORNRHI
Reference Range Upper Limit in Orig Unit
- LBSTRESC
Character Result/Finding in Std Format
- LBSTRESN
Numeric Result/Finding in Standard Units
- LBSTRESU
Standard Units
- LBSTNRLO
Reference Range Lower Limit-Std Units
- LBSTNRHI
Reference Range Upper Limit-Std Units
- LBNRIND
Reference Range Indicator
- LBBLFL
Baseline Flag
- LBFAST
Fasting Status
- VISITNUM
Visit Number
- VISIT
Visit Name
- VISITDY
Planned Study Day of Visit
- LBDTC
Date/Time of Specimen Collection
- LBDY
Study Day of Specimen Collection
Details
Laboratory Measurements Dataset-metabolic
A SDTM LB dataset containing relevant laboratory measurements for metabolic studies
Contains a set of 9 unique Test Short Names and Test Names:
| LBTESTCD | LBTEST |
| ALB | Albumin |
| ALP | Alkaline Phosphatase |
| AST | Aspartate Aminotransferase |
| CHOL | Cholesterol |
| GGT | Gamma Glutamyl Transferase |
| GLUC | Glucose |
| HBA1CHGB | Hemoglobin A1C/Hemoglobin |
| INSULIN | Insulin |
| TRIG | Triglycerides |
Source
Constructed by admiralmetabolic developers
Medical History
Description
An updated SDTM MH dataset that uses data from the CDISC pilot project
Usage
mh
Format
A data frame with 28 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- MHSEQ
Sequence Number
- MHSPID
Sponsor-Defined Identifier
- MHTERM
Reported Term for the Medical History
- MHLLT
Lowest Level Term
- MHDECOD
Dictionary-Derived Term
- MHHLT
High Level Term
- MHHLGT
High Level Group Term
- MHCAT
Category for Medical History
- MHBODSYS
Body System or Organ Class
- MHSEV
Severity/Intensity
- VISITNUM
Visit Number
- VISIT
Visit Name
- VISITDY
Planned Study Day of Visit
- MHDTC
Date/Time of History Collection
- MHSTDTC
Start Date/Time of Medical History Event
- MHDY
Study Day of History Collection
- MHENDTC
End Date/Time of Medical History Event
- MHPRESP
Medical History Event Pre-Specified
- MHOCCUR
Medical History Occurrence
- MHSTRTPT
Start Relative to Reference Time Point
- MHENRTPT
End Relative to Reference Time Point
- MHSTTPT
Start Reference Time Point
- MHENTPT
End Reference Time Point
- MHENRF
End Relative to Reference Period
- MHSTAT
Completion Status
Details
Medical History
An updated SDTM MH dataset that uses data from the CDISC pilot project
Author(s)
Annie Yang
Source
Access the source of the Medical History dataset.
Ophthalmic Examinations for Ophthalmology
Description
A SDTM OE dataset simulated by Ophthalmology team
Usage
oe_ophtha
Format
A data frame with 25 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- OESEQ
Sequence Number
- OECAT
Category for Ophthalmic Test or Exam
- OESCAT
Subcategory for Ophthalmic Test or Exam
- OEDTC
Date/Time of Collection
- VISIT
Visit Name
- VISITNUM
Visit Number
- VISITDY
Planned Study Day of Visit
- OESTRESN
Numeric Result/Finding in Standard Units
- OESTRESC
Character Result/Finding in Std Format
- OEORRES
Result or Finding in Original Units
- OETEST
Name of Ophthalmic Test or Examination
- OETESTCD
Short Name of Ophthalmic Test or Exam
- OETSTDTL
Ophthalmic Test or Exam Detail
- OELAT
Laterality
- OELOC
Location Used for the Measurement
- OEDY
Study Day of Visit/Collection/Exam
- OEMETHOD
Method of Test or Examination
- OEORRESU
Original Units
- OESTRESU
Standard Units
- OESTAT
Completion Status
- OETPT
Planned Time Point Name
- OETPTNUM
Planned Time Point Number
Details
Ophthalmic Examinations for Ophthalmology
A SDTM OE dataset simulated by Ophthalmology team
Contains a set of 4 unique Test Short Names and Test Names:
| OETESTCD | OETEST |
| CSUBTH | Center Subfield Thickness |
| DRSSR | Diabetic Retinopathy Sev Recode Value |
| IOP | Intraocular Pressure |
| VACSCORE | Visual Acuity Score |
Author(s)
Gordon Miller
Source
Generated dataset.
Pharmacokinetic Concentrations
Description
A SDTM PC dataset simulated by Antonio Rodriguez Contesti
Usage
pc
Format
A data frame with 20 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- PCSEQ
Sequence Number
- PCTESTCD
Pharmacokinetic Test Short Name
- PCTEST
Pharmacokinetic Test Name
- PCORRES
Result or Finding in Original Units
- PCORRESU
Original Units
- PCSTRESC
Character Result/Finding in Std Format
- PCSTRESN
Numeric Result/Finding in Standard Units
- PCSTRESU
Standard Units
- PCNAM
Vendor Name
- PCSPEC
Specimen Material Type
- PCLLOQ
Lower Limit of Quantitation
- VISIT
Visit Name
- VISITNUM
Visit Number
- PCDTC
Date/Time of Specimen Collection
- PCDY
Actual Study Day of Specimen Collection
- PCTPT
Planned Time Point Name
- PCTPTNUM
Planned Time Point Number
Details
Pharmacokinetic Concentrations
A SDTM PC dataset simulated by Antonio Rodriguez Contesti
Contains a set of 1 unique Test Short Name and Test Name:
| PCTESTCD | PCTEST |
| XAN | XANOMELINE |
Author(s)
Antonio Rodriguez Contesti
Source
Access the source of the Pharmacokinetic Concentrations dataset.
Pharmacokinetic Parameters
Description
A SDTM PP dataset simulated by Antonio Rodriguez Contesti
Usage
pp
Format
A data frame with 14 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- PPSEQ
Sequence Number
- PPTESTCD
Parameter Short Name
- PPTEST
Parameter Name
- PPCAT
Parameter Category
- PPORRES
Result or Finding in Original Units
- PPORRESU
Original Units
- PPSTRESC
Character Result/Finding in Std Format
- PPSTRESN
Numeric Result/Finding in Standard Units
- PPSTRESU
Standard Units
- PPSPEC
Specimen Material Type
- PPRFDTC
Date/Time of Reference Point
Details
Pharmacokinetic Parameters
A SDTM PP dataset simulated by Antonio Rodriguez Contesti
Contains a set of 10 unique Test Short Names and Test Names:
| PPTESTCD | PPTEST |
| AUCALL | AUC All |
| AUCLST | AUC to Last Nonzero Conc |
| CLST | Last Nonzero Conc |
| CMAX | Max Conc |
| LAMZ | Lambda z |
| LAMZHL | Half-Life Lambda z |
| LAMZNPT | Number of Points for Lambda z |
| RCAMINT | Ae |
| RENALCL | CLR |
| TMAX | Time of CMAX |
Author(s)
Antonio Rodriguez Contesti
Source
Access the source of the Pharmacokinetic Parameters dataset.
Questionnaire Dataset-metabolic
Description
A SDTM QS dataset containing COEQ data (Control of Eating Questionnaire) for metabolic studies. Note that University of Leeds are the copyright holders of the Control of Eating Questionnaire (CoEQ) and the test data included within pharmaversesdtm as well as the ADCOEQ code are for not-for-profit use only within admiralmetabolic and pharmaverse-related examples/documentation. Any persons or companies wanting to use the CoEQ should request a license to do so from the following link.
Usage
qs_metabolic
Format
A data frame with 18 columns:
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- DOMAIN
Domain Abbreviation
- VISIT
Visit Name
- VISITNUM
Visit Number
- VISITDY
Planned Study Day of Visit
- QSBLFL
Baseline Flag
- QSDTC
Date/Time of Finding
- QSDY
Study Day of Finding
- QSCAT
Category for Questionnaire
- QSTEST
Questionnaire Test Name
- QSTESTCD
Questionnaire Test Short Name
- QSORRES
Result or Finding in Original Units
- QSORRESU
Original Units
- QSSTRESC
Character Result/Finding in Std Format
- QSSTRESN
Numeric Result/Finding in Standard Units
- QSSTRESU
Standard Units
- QSSEQ
Sequence Number
Details
Questionnaire Dataset-metabolic
A SDTM QS dataset containing COEQ data (Control of Eating Questionnaire) for metabolic studies. Note that University of Leeds are the copyright holders of the Control of Eating Questionnaire (CoEQ) and the test data included within pharmaversesdtm as well as the ADCOEQ code are for not-for-profit use only within admiralmetabolic and pharmaverse-related examples/documentation. Any persons or companies wanting to use the CoEQ should request a license to do so from the following link.
Contains a set of 21 unique Test Short Names and Test Names:
| QSTESTCD | QSTEST |
| COEQ01 | How hungry have you felt? |
| COEQ02 | How full have you felt? |
| COEQ03 | How strong was your desire to eat sweet foods? |
| COEQ04 | How strong was your desire to eat savoury foods? |
| COEQ05 | How happy have you felt? |
| COEQ06 | How anxious have you felt? |
| COEQ07 | How alert have you felt? |
| COEQ08 | How contented have you felt? |
| COEQ09 | During the last 7 days how often have you had food cravings? |
| COEQ10 | How strong have any food cravings been? |
| COEQ11 | How difficult has it been to resist any food cravings? |
| COEQ12 | How often have you eaten in response to food cravings? |
| COEQ13 | Chocolate or chocolate flavoured foods |
| COEQ14 | Other sweet foods (cakes, pastries, biscuits, etc) |
| COEQ15 | Fruit or fruit juice |
| COEQ16 | Dairy foods (cheese, yoghurts, milk, etc) |
| COEQ17 | Starchy foods (bread, rice, pasta, etc) |
| COEQ18 | Savoury foods (french fries, crisps, burgers, pizza, etc) |
| COEQ19 | Generally, how difficult has it been to control your eating? |
| COEQ20 | Which one food makes it most difficult for you to control eating? |
| COEQ21 | How difficult has it been to resist eating this food during the last 7 days? |
Source
Constructed by admiralmetabolic developers
Questionnaire for Ophthalmology
Description
An example Questionnaires SDTM dataset with ophthalmology-specific questionnaire of NEI VFQ-25
Usage
qs_ophtha
Format
A data frame with 20 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- QSSEQ
Sequence Number
- QSTESTCD
Question Short Name
- QSTEST
Question Name
- QSCAT
Category of Question
- QSSCAT
Subcategory for Question
- QSORRES
Finding in Original Units
- QSORRESU
Original Units
- QSSTRESC
Character Result/Finding in Std Format
- QSSTRESN
Numeric Finding in Standard Units
- QSSTRESU
Standard Units
- QSBLFL
Baseline Flag
- QSDRVFL
Derived Flag
- VISITNUM
Visit Number
- VISIT
Visit Name
- VISITDY
Planned Study Day of Visit
- QSDTC
Date/Time of Finding
- QSDY
Study Day of Finding
Details
Questionnaire for Ophthalmology
An example Questionnaires SDTM dataset with ophthalmology-specific questionnaire of NEI VFQ-25
Contains a set of 29 unique Test Short Names and Test Names:
| QSTESTCD | QSTEST |
| VFQ1 | Your Overall Health Is |
| VFQ10 | Difficulty Noticing Objects to Side |
| VFQ11 | Difficulty Seeing How People React |
| VFQ12 | Difficulty Picking Out Own Clothes |
| VFQ13 | Difficulty Visiting With People |
| VFQ14 | Difficulty Going Out to See Movies |
| VFQ15 | Are You Currently Driving |
| VFQ16 | Difficulty Driving During Daytime |
| VFQ17 | Difficulty Driving at Night |
| VFQ18 | Driving in Difficult Conditions |
| VFQ19 | Eye Pain Keep You From Doing What You Like |
| VFQ2 | Eyesight Using Both Eyes Is |
| VFQ20 | I Stay Home Most of the Time |
| VFQ21 | I Feel Frustrated a Lot of the Time |
| VFQ22 | I Need a Lot of Help From Others |
| VFQ23 | Worry I'll Do Embarrassing Things |
| VFQ24 | Difficulty Reading Small Print |
| VFQ25 | Difficulty Figure Out Bill Accuracy |
| VFQ26 | Difficulty Shaving or Styling Hair |
| VFQ27 | Difficulty Recognizing People |
| VFQ28 | Difficulty Taking Part in Sports |
| VFQ29 | Difficulty Seeing Programs on TV |
| VFQ3 | How Often You Worry About Eyesight |
| VFQ4 | How Often Pain in and Around Eyes |
| VFQ5 | Difficulty Reading Newspapers |
| VFQ6 | Difficulty Doing Work/Hobbies |
| VFQ7 | Difficulty Finding on Crowded Shelf |
| VFQ8 | Difficulty Reading Street Signs |
| VFQ9 | Difficulty Going Down Step at Night |
Source
Constructed using qs from the pharmaversesdtm package
Disease Response for Oncology
Description
A SDTM RS dataset simulated by Gopi Vegesna
Usage
rs_onco
Format
A data frame with 19 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- RSSEQ
Sequence Number
- RSLNKGRP
Link Group
- RSTESTCD
Response Assessment Short Name
- RSTEST
Response Assessment Name
- RSCAT
Category for Response Assessment
- RSORRES
Response Assessment Original Result
- RSSTRESC
Response Assessment Result in Std Format
- RSSTAT
Completion Status
- RSREASND
Reason Response Assessment Not Performed
- RSEVAL
Evaluator
- RSEVALID
Evaluator Identifier
- RSACPTFL
Accepted Record Flag
- VISITNUM
Visit Number
- VISIT
Visit Name
- RSDTC
Date/Time of Response Assessment
- RSDY
Study Day of Response Assessment
Details
Disease Response for Oncology
A SDTM RS dataset simulated by Gopi Vegesna
Contains a set of 4 unique Test Short Names and Test Names:
| RSTESTCD | RSTEST |
| NEWLPROG | New Lesion Progression |
| NTRGRESP | Non-target Response |
| OVRLRESP | Overall Response |
| TRGRESP | Target Response |
Author(s)
Gopi Vegesna
Source
Access the source of the Disease Response for Oncology dataset.
Disease Response (GCIG)
Description
A SDTM RS dataset using GCIG criteria. The dataset contains just a few patients. It is intended for vignettes and examples of ADaM dataset creation.
Usage
rs_onco_ca125
Format
A data frame with 13 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- RSSEQ
Sequence Number
- RSTESTCD
Assessment Short Name
- RSTEST
Assessment Name
- RSCAT
Category for Assessment
- RSORRES
Result or Finding in Original Units
- RSSTRESC
Character Result/Finding in Std Format
- RSEVAL
Evaluator
- VISITNUM
Visit Number
- VISIT
Visit Name
- RSDTC
Date/Time of Assessment
Details
Disease Response (GCIG)
A SDTM RS dataset using GCIG criteria. The dataset contains just a few patients. It is intended for vignettes and examples of ADaM dataset creation.
Contains a set of 1 unique Test Short Name and Test Name:
| RSTESTCD | RSTEST |
| OVRLRESP | Overall Response |
Author(s)
Vinh Nguyen
Source
Generated dataset (rs_supprs_onco_ca125.R)
Disease Response (IMWG)
Description
A SDTM RS dataset using IMWG criteria intended for examples of ADaM dataset creation
Usage
rs_onco_imwg
Format
A data frame with 17 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- RSSEQ
Sequence Number
- RSLNKGRP
Link Group ID
- RSTESTCD
Assessment Short Name
- RSTEST
Assessment Name
- RSCAT
Category for Assessment
- RSORRES
Result or Finding in Original Units
- RSSTRESC
Character Result/Finding in Std Format
- RSSTAT
Completion Status
- RSREASND
Reason Not Done
- RSEVAL
Evaluator
- VISITNUM
Visit Number
- VISIT
Visit Name
- RSDTC
Date/Time of Assessment
- RSDY
Study Day of Assessment
Details
Disease Response (IMWG)
A SDTM RS dataset using IMWG criteria intended for examples of ADaM dataset creation
Contains a set of 1 unique Test Short Name and Test Name:
| RSTESTCD | RSTEST |
| OVRLRESP | Overall Response |
Author(s)
Vinh Nguyen
Source
Derived from tr_onco_recist
Disease Response (iRECIST) for Oncology
Description
A SDTM RS dataset using iRECIST intended for examples of ADaM dataset creation
Usage
rs_onco_irecist
Format
A data frame with 19 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- RSSEQ
Sequence Number
- RSLNKGRP
Link Group ID
- RSTESTCD
Assessment Short Name
- RSTEST
Assessment Name
- RSCAT
Category for Assessment
- RSORRES
Result or Finding in Original Units
- RSSTRESC
Character Result/Finding in Std Format
- RSSTAT
Completion Status
- RSREASND
Reason Not Done
- RSEVAL
Evaluator
- RSEVALID
Evaluator Identifier
- RSACPTFL
Accepted Record Flag
- VISITNUM
Visit Number
- VISIT
Visit Name
- RSDTC
Date/Time of Assessment
- RSDY
Study Day of Assessment
Details
Disease Response (iRECIST) for Oncology
A SDTM RS dataset using iRECIST intended for examples of ADaM dataset creation
Contains a set of 6 unique Test Short Names and Test Names:
| RSTESTCD | RSTEST |
| IRECLIND | Last iRECIST Assessment Indicator |
| NEWLIND | New Lesion Indicator |
| NEWLPROG | New Lesion Progression |
| NTRGRESP | Non-target Response |
| OVRLRESP | Overall Response |
| TRGRESP | Target Response |
Author(s)
Rohan Thampi
Source
Generated dataset.
Disease Response (PCWG3) for Oncology
Description
A SDTM RS dataset for oncology studies using PCWG3 criteria intended for examples of ADaM dataset creation
Usage
rs_onco_pcwg3
Format
A data frame with 14 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- RSSEQ
Sequence Number
- RSTESTCD
Response Assessment Short Name
- RSTEST
Response Assessment Name
- RSCAT
Category for Response Assessment
- RSORRES
Response Assessment Original Result
- RSSTRESC
Response Assessment Result in Std Format
- RSEVAL
Evaluator
- VISITNUM
Visit Number
- VISIT
Visit Name
- RSDTC
Date/Time of Response Assessment
- RSDY
Study Day of Response Assessment
Details
Disease Response (PCWG3) for Oncology
A SDTM RS dataset for oncology studies using PCWG3 criteria intended for examples of ADaM dataset creation
Contains a set of 4 unique Test Short Names and Test Names:
| RSTESTCD | RSTEST |
| BONERESP | Bone Response |
| OVRLRESP | Overall Response |
| SFTSRESP | Soft Tissue Response |
| TMRESP | Tumor Marker Response |
Author(s)
Tomoyuki Namai
Source
Generated dataset
Disease Response (RECIST 1.1) for Oncology
Description
A SDTM RS dataset using RECIST 1.1 intended for examples of ADaM dataset creation
Usage
rs_onco_recist
Format
A data frame with 14 columns:
- DOMAIN
Domain Abbreviation
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- VISITNUM
Visit Number
- VISIT
Visit Name
- RSTESTCD
Assessment Short Name
- RSTEST
Assessment Name
- RSORRES
Result or Finding in Original Units
- RSSTRESC
Character Result/Finding in Std Format
- RSEVAL
Evaluator
- RSEVALID
Evaluator Identifier
- RSACPTFL
Accepted Record Flag
- RSDTC
Date/Time of Assessment
- RSSEQ
Sequence Number
Details
Disease Response (RECIST 1.1) for Oncology
A SDTM RS dataset using RECIST 1.1 intended for examples of ADaM dataset creation
Contains a set of 1 unique Test Short Name and Test Name:
| RSTESTCD | RSTEST |
| OVRLRESP | Overall Response |
Author(s)
Stefan Bundfuss
Source
Generated dataset.
Subject Characteristic for Ophthalmology
Description
A SDTM SC dataset simulated by Ophthalmology team
Usage
sc_ophtha
Format
A data frame with 12 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- SCSEQ
Sequence Number
- SCTESTCD
Subject Characteristic Short Name
- SCTEST
Subject Characteristic
- SCCAT
Category for Subject Characteristic
- SCORRES
Result or Finding in Original Units
- SCSTRESC
Character Result/Finding in Std Format
- EPOCH
Epoch
- SCDTC
Date/Time of Collection
- SCDY
Study Day of Examination
Details
Subject Characteristic for Ophthalmology
A SDTM SC dataset simulated by Ophthalmology team
Contains a set of 1 unique Test Short Name and Test Name:
| SCTESTCD | SCTEST |
| FOCID | Focus of Study-Specific Interest |
Author(s)
Gordon Miller
Source
Generated dataset.
SDG
Description
An example SDG dataset
Usage
sdg_db
Format
A data frame with 5 columns:
- termchar
Reported Term
- sdg_name
Name
- sdg_id
Name ID
- termvar
Variable
- version
Version
Details
SDG
An example SDG dataset
Source
Access the source of the SDG dataset.
Standardized MedDRA Queries
Description
An example SMQ dataset
Usage
smq_db
Format
A data frame with 6 columns:
- termchar
Reported Term
- scope
Scope
- smq_name
Name
- smq_id
Name ID
- version
Version
- termvar
Variable
Details
Standardized MedDRA Queries
An example SMQ dataset
Source
Generated dataset.
Supplemental Adverse Events
Description
A SDTM SUPPAE dataset from the CDISC pilot project
Usage
suppae
Format
A data frame with 10 columns:
- STUDYID
Study Identifier
- RDOMAIN
Related Domain Abbreviation
- USUBJID
Unique Subject Identifier
- IDVAR
Identifying Variable
- IDVARVAL
Identifying Variable Value
- QNAM
Qualifier Variable Name
- QLABEL
Qualifier Variable Label
- QVAL
Data Value
- QORIG
Origin
- QEVAL
Evaluator
Details
Supplemental Adverse Events
A SDTM SUPPAE dataset from the CDISC pilot project
Source
Access the source of the Supplemental Adverse Events dataset.
Supplemental Qualifiers for Clinical Events for Vaccine
Description
An example SDTM SUPPCE for vaccine studies
Usage
suppce_vaccine
Format
A data frame with 9 columns:
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- RDOMAIN
Related Domain Abbreviation
- IDVAR
Identifying Variable
- IDVARVAL
Identifying Variable Value
- QNAM
Qualifier Variable Name
- QVAL
Data Value
- QLABEL
Qualifier Variable Label
- QORIG
Origin
Details
Supplemental Qualifiers for Clinical Events for Vaccine
An example SDTM SUPPCE for vaccine studies
Source
Constructed by admiralvaccine developers
Supplemental Demography
Description
A SDTM SUPPDM dataset from the CDISC pilot project
Usage
suppdm
Format
A data frame with 10 columns:
- STUDYID
Study Identifier
- RDOMAIN
Related Domain Abbreviation
- USUBJID
Unique Subject Identifier
- IDVAR
Identifying Variable
- IDVARVAL
Identifying Variable Value
- QNAM
Qualifier Variable Name
- QLABEL
Qualifier Variable Label
- QVAL
Data Value
- QORIG
Origin
- QEVAL
Evaluator
Details
Supplemental Demography
A SDTM SUPPDM dataset from the CDISC pilot project
Source
Generated dataset.
Supplemental Qualifiers for Demographics for Vaccine
Description
An example SDTM SUPPDM dataset for vaccine studies
Usage
suppdm_vaccine
Format
A data frame with 9 columns:
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- RDOMAIN
Related Domain Abbreviation
- IDVAR
Identifying Variable
- IDVARVAL
Identifying Variable Value
- QNAM
Qualifier Variable Name
- QVAL
Data Value
- QLABEL
Qualifier Variable Label
- QORIG
Origin
Details
Supplemental Qualifiers for Demographics for Vaccine
An example SDTM SUPPDM dataset for vaccine studies
Source
Constructed by admiralvaccine developers
Supplemental Disposition
Description
A SDTM SUPPDS dataset from the CDISC pilot project
Usage
suppds
Format
A data frame with 9 columns:
- STUDYID
Study Identifier
- RDOMAIN
Related Domain Abbreviation
- USUBJID
Unique Subject Identifier
- IDVAR
Identifying Variable
- IDVARVAL
Identifying Variable Value
- QNAM
Qualifier Variable Name
- QLABEL
Qualifier Variable Label
- QVAL
Data Value
- QORIG
Origin
Details
Supplemental Disposition
A SDTM SUPPDS dataset from the CDISC pilot project
Source
Access the source of the Supplemental Disposition dataset.
Supplemental Qualifiers for Exposures for Vaccine
Description
An example SDTM SUPPEX dataset for vaccine studies
Usage
suppex_vaccine
Format
A data frame with 9 columns:
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- RDOMAIN
Related Domain Abbreviation
- IDVAR
Identifying Variable
- IDVARVAL
Identifying Variable Value
- QNAM
Qualifier Variable Name
- QVAL
Data Value
- QLABEL
Qualifier Variable Label
- QORIG
Origin
Details
Supplemental Qualifiers for Exposures for Vaccine
An example SDTM SUPPEX dataset for vaccine studies
Source
Constructed by admiralvaccine developers
Supplemental Qualifiers for Findings About for Clinical Events for Vaccine
Description
An example SDTM SUPPFACE dataset for vaccine studies
Usage
suppface_vaccine
Format
A data frame with 9 columns:
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- RDOMAIN
Related Domain Abbreviation
- IDVAR
Identifying Variable
- IDVARVAL
Identifying Variable Value
- QNAM
Qualifier Variable Name
- QVAL
Data Value
- QLABEL
Qualifier Variable Label
- QORIG
Origin
Details
Supplemental Qualifiers for Findings About for Clinical Events for Vaccine
An example SDTM SUPPFACE dataset for vaccine studies
Source
Constructed by admiralvaccine developers
Supplemental Qualifiers for Immunogenicity Specimen Assessments for Vaccine
Description
An example SDTM SUPPIS dataset for vaccine studies
Usage
suppis_vaccine
Format
A data frame with 10 columns:
- STUDYID
Study Identifier
- RDOMAIN
Related Domain Abbreviation
- USUBJID
Unique Subject Identifier
- IDVAR
Identifying Variable
- IDVARVAL
Identifying Variable Value
- QNAM
Qualifier Variable Name
- QLABEL
Qualifier Variable Label
- QVAL
Data Value
- QORIG
Origin
- QEVAL
Evaluator
Details
Supplemental Qualifiers for Immunogenicity Specimen Assessments for Vaccine
An example SDTM SUPPIS dataset for vaccine studies
Source
Constructed by admiralpeds developers
Supplemental Qualifiers for RS_ONCO_CA125
Description
A SDTM supplemental RS dataset using GCIG criteria. It is intended to be used together with rs_onco_ca125.
Usage
supprs_onco_ca125
Format
A data frame with 9 columns:
- STUDYID
Study Identifier
- RDOMAIN
Related Domain Abbreviation
- USUBJID
Unique Subject Identifier
- IDVAR
Identifying Variable
- IDVARVAL
Identifying Variable Value
- QNAM
Qualifier Variable Name
- QLABEL
Qualifier Variable Label
- QVAL
Data Value
- QORIG
Origin
Details
Supplemental Qualifiers for RS_ONCO_CA125
A SDTM supplemental RS dataset using GCIG criteria. It is intended to be used together with rs_onco_ca125.
Author(s)
Vinh Nguyen
Source
Generated dataset (rs_supprs_onco_ca125.R)
Supplemental Qualifiers for RS_ONCO_IMWG
Description
A SDTM supplemental RS dataset using IMWG criteria intended to be used with rs_onco_imwg
Usage
supprs_onco_imwg
Format
A data frame with 9 columns:
- STUDYID
Study Identifier
- RDOMAIN
Related Domain Abbreviation
- USUBJID
Unique Subject Identifier
- IDVAR
Identifying Variable
- IDVARVAL
Identifying Variable Value
- QNAM
Qualifier Variable Name
- QLABEL
Qualifier Variable Label
- QVAL
Data Value
- QORIG
Origin
Details
Supplemental Qualifiers for RS_ONCO_IMWG
A SDTM supplemental RS dataset using IMWG criteria intended to be used with rs_onco_imwg
Author(s)
Vinh Nguyen
Source
Access the source of the Supplemental Qualifiers for RS_ONCO_IMWG dataset.
Supplemental Tumor Results for Oncology
Description
A SDTM SUPPTR dataset simulated by Gopi Vegesna
Usage
supptr_onco
Format
A data frame with 9 columns:
- STUDYID
Study Identifier
- RDOMAIN
Related Domain Abbreviation
- USUBJID
Unique Subject Identifier
- IDVAR
Identifying Variable
- IDVARVAL
Identifying Variable Value
- QNAM
Qualifier Variable Name
- QLABEL
Qualifier Variable Label
- QVAL
Data Value
- QORIG
Origin
Details
Supplemental Tumor Results for Oncology
A SDTM SUPPTR dataset simulated by Gopi Vegesna
Author(s)
Gopi Vegesna
Source
Access the source of the Supplemental Tumor Results for Oncology dataset.
Subject Visits
Description
A SDTM SV dataset from the CDISC pilot project with corrected duplicate observation
Usage
sv
Format
A data frame with 8 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- VISITNUM
Visit Number
- VISIT
Visit Name
- VISITDY
Planned Study Day of Visit
- SVSTDTC
Start Date/Time of Visit
- SVENDTC
End Date/Time of Visit
Details
Subject Visits
A SDTM SV dataset from the CDISC pilot project with corrected duplicate observation
Source
Constructed by admiralvaccine developers
Tumor Results for Oncology
Description
A SDTM TR dataset simulated by Gopi Vegesna
Usage
tr_onco
Format
A data frame with 24 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- TRSEQ
Sequence Number
- TRGRPID
Group ID
- TRLNKGRP
Link Group
- TRLNKID
Link ID
- TRTESTCD
Tumor Assessment Short Name
- TRTEST
Tumor Assessment Test Name
- TRORRES
Result or Finding in Original Units
- TRORRESU
Original Units
- TRSTRESC
Character Result/Finding in Std Format
- TRSTRESN
Numeric Result/Finding in Standard Units
- TRSTRESU
Standard Units
- TRSTAT
Completion Status
- TRREASND
Reason Tumor Measurement Not Performed
- TRMETHOD
Method used to Identify the Tumor
- TREVAL
Evaluator
- TREVALID
Evaluator Identifier
- TRACPTFL
Accepted Record Flag
- VISITNUM
Visit Number
- VISIT
Visit Name
- TRDTC
Date/Time of Tumor Measurement
- TRDY
Study Day of Tumor Measurement
Details
Tumor Results for Oncology
A SDTM TR dataset simulated by Gopi Vegesna
Contains a set of 5 unique Test Short Names and Test Names:
| TRTESTCD | TRTEST |
| DIAMETER | Diameter |
| LDIAM | Longest Diameter |
| LPERP | Longest Perpendicular |
| SUMDIAM | Sum of Diameter |
| TUMSTATE | Tumor State |
Author(s)
Gopi Vegesna
Source
Generated dataset.
Tumor Results (RECIST 1.1) for Oncology
Description
A SDTM TR dataset using RECIST 1.1 intended for examples of ADaM dataset creation
Usage
tr_onco_recist
Format
A data frame with 19 columns:
- DOMAIN
Domain Abbreviation
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- TRGRPID
Group ID
- TRLNKID
Link ID
- TRTESTCD
Tumor/Lesion Assessment Short Name
- TRTEST
Tumor/Lesion Assessment Test Name
- TRORRES
Result or Finding in Original Units
- TRORRESU
Original Units
- TRSTRESC
Character Result/Finding in Std Format
- TRSTRESN
Numeric Result/Finding in Standard Units
- TRSTRESU
Standard Units
- VISITNUM
Visit Number
- VISIT
Visit Name
- TREVAL
Evaluator
- TREVALID
Evaluator Identifier
- TRACPTFL
Accepted Record Flag
- TRDTC
Date/Time of Tumor/Lesion Measurement
- TRSEQ
Sequence Number
Details
Tumor Results (RECIST 1.1) for Oncology
A SDTM TR dataset using RECIST 1.1 intended for examples of ADaM dataset creation
Contains a set of 3 unique Test Short Names and Test Names:
| TRTESTCD | TRTEST |
| LDIAM | Longest Diameter |
| LPERP | Longest Perpendicular |
| TUMSTATE | Tumor State |
Author(s)
Stefan Bundfuss
Source
Generated dataset.
Trial Design
Description
A SDTM TS dataset from the CDISC pilot project
Usage
ts
Format
A data frame with 6 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- TSSEQ
Sequence Number
- TSPARMCD
Trial Summary Parameter Short Name
- TSPARM
Trial Summary Parameter
- TSVAL
Parameter Value
Details
Trial Design
A SDTM TS dataset from the CDISC pilot project
Source
Access the source of the Trial Design dataset.
Tumor Identification for Oncology
Description
A SDTM TU dataset simulated by Gopi Vegesna
Usage
tu_onco
Format
A data frame with 18 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- TUSEQ
Sequence Number
- TULNKID
Link ID
- TUTESTCD
Tumor Identification Short Name
- TUTEST
Tumor Identification Test Name
- TUORRES
Tumor Identification Result
- TUSTRESC
Tumor Identification Result Std. Format
- TULOC
Location of the Tumor
- TUMETHOD
Method of Identification
- TUEVAL
Evaluator
- TUEVALID
Evaluator Identifier
- TUACPTFL
Accepted Record Flag
- VISITNUM
Visit Number
- VISIT
Visit Name
- TUDTC
Date/Time of Tumor Identification
- TUDY
Study Day of Tumor Identification
Details
Tumor Identification for Oncology
A SDTM TU dataset simulated by Gopi Vegesna
Contains a set of 1 unique Test Short Name and Test Name:
| TUTESTCD | TUTEST |
| TUMIDENT | Tumor Identification |
Author(s)
Gopi Vegesna
Source
Generated dataset.
Tumor Identification (RECIST 1.1) for Oncology
Description
A SDTM TU dataset using RECIST 1.1 intended for examples of ADaM dataset creation
Usage
tu_onco_recist
Format
A data frame with 16 columns:
- DOMAIN
Domain Abbreviation
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- VISIT
Visit Name
- VISITNUM
Visit Number
- TULOC
Location of the Tumor/Lesion
- TUTESTCD
Tumor/Lesion ID Short Name
- TUTEST
Tumor/Lesion ID Test Name
- TUORRES
Tumor/Lesion ID Result
- TUSTRESC
Tumor/Lesion ID Result Std. Format
- TUMETHOD
Method of Identification
- TULNKID
Link ID
- TUEVAL
Evaluator
- TUEVALID
Evaluator Identifier
- TUACPTFL
Accepted Record Flag
- TUSEQ
Sequence Number
Details
Tumor Identification (RECIST 1.1) for Oncology
A SDTM TU dataset using RECIST 1.1 intended for examples of ADaM dataset creation
Contains a set of 1 unique Test Short Name and Test Name:
| TUTESTCD | TUTEST |
| TUMIDENT | Tumor Identification |
Author(s)
Stefan Bundfuss
Source
Generated dataset.
Vital Signs
Description
A SDTM VS dataset from the CDISC pilot project
Usage
vs
Format
A data frame with 24 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- VSSEQ
Sequence Number
- VSTESTCD
Vital Signs Test Short Name
- VSTEST
Vital Signs Test Name
- VSPOS
Vital Signs Position of Subject
- VSORRES
Result or Finding in Original Units
- VSORRESU
Original Units
- VSSTRESC
Character Result/Finding in Std Format
- VSSTRESN
Numeric Result/Finding in Standard Units
- VSSTRESU
Standard Units
- VSSTAT
Completion Status
- VSLOC
Location of Vital Signs Measurement
- VSBLFL
Baseline Flag
- VISITNUM
Visit Number
- VISIT
Visit Name
- VISITDY
Planned Study Day of Visit
- VSDTC
Date/Time of Measurements
- VSDY
Study Day of Vital Signs
- VSTPT
Planned Time Point Name
- VSTPTNUM
Planned Time Point Number
- VSELTM
Planned Elapsed Time from Time Point Ref
- VSTPTREF
Time Point Reference
Details
Vital Signs
A SDTM VS dataset from the CDISC pilot project
Contains a set of 6 unique Test Short Names and Test Names:
| VSTESTCD | VSTEST |
| DIABP | Diastolic Blood Pressure |
| HEIGHT | Height |
| PULSE | Pulse Rate |
| SYSBP | Systolic Blood Pressure |
| TEMP | Temperature |
| WEIGHT | Weight |
Source
Generated dataset.
Vital signs Dataset-metabolic
Description
A SDTM VS dataset for metabolic studies
Usage
vs_metabolic
Format
A data frame with 24 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- VSSEQ
Sequence Number
- VSTESTCD
Vital Signs Test Short Name
- VSTEST
Vital Signs Test Name
- VSPOS
Vital Signs Position of Subject
- VSORRES
Result or Finding in Original Units
- VSORRESU
Original Units
- VSSTRESC
Character Result/Finding in Std Format
- VSSTRESN
Numeric Result/Finding in Standard Units
- VSSTRESU
Standard Units
- VSSTAT
Completion Status
- VSLOC
Location of Vital Signs Measurement
- VSBLFL
Baseline Flag
- VISITNUM
Visit Number
- VISIT
Visit Name
- VISITDY
Planned Study Day of Visit
- VSDTC
Date/Time of Measurements
- VSDY
Study Day of Vital Signs
- VSTPT
Planned Time Point Name
- VSTPTNUM
Planned Time Point Number
- VSELTM
Planned Elapsed Time from Time Point Ref
- VSTPTREF
Time Point Reference
Details
Vital signs Dataset-metabolic
A SDTM VS dataset for metabolic studies
Contains a set of 9 unique Test Short Names and Test Names:
| VSTESTCD | VSTEST |
| BMI | Body Mass Index |
| DIABP | Diastolic Blood Pressure |
| HEIGHT | Height |
| HIPCIR | Hip Circumference |
| PULSE | Pulse Rate |
| SYSBP | Systolic Blood Pressure |
| TEMP | Temperature |
| WEIGHT | Weight |
| WSTCIR | Waist Circumference |
Source
Constructed by admiralmetabolic developers
Vital signs Dataset-pediatrics
Description
An updated SDTM VS dataset with anthropometric measurements for pediatric patients
Usage
vs_peds
Format
A data frame with 26 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- VSSEQ
Sequence Number
- VSTESTCD
Vital Signs Test Short Name
- VSTEST
Vital Signs Test Name
- VSPOS
Vital Signs Position of Subject
- VSORRES
Result or Finding in Original Units
- VSORRESU
Original Units
- VSSTRESC
Character Result/Finding in Std Format
- VSSTRESN
Numeric Result/Finding in Standard Units
- VSSTRESU
Standard Units
- VSSTAT
Completion Status
- VSLOC
Location of Vital Signs Measurement
- VSBLFL
Baseline Flag
- VISITNUM
Visit Number
- VISIT
Visit Name
- VISITDY
Planned Study Day of Visit
- VSDTC
Date/Time of Measurements
- VSDY
Study Day of Vital Signs
- VSTPT
Planned Time Point Name
- VSTPTNUM
Planned Time Point Number
- VSELTM
Planned Elapsed Time from Time Point Ref
- VSTPTREF
Time Point Reference
- VSEVAL
Evaluator
- EPOCH
Epoch
Details
Vital signs Dataset-pediatrics
An updated SDTM VS dataset with anthropometric measurements for pediatric patients
Contains a set of 4 unique Test Short Names and Test Names:
| VSTESTCD | VSTEST |
| BMI | BMI |
| HDCIRC | Head Circumference |
| HEIGHT | Height |
| WEIGHT | Weight |
Source
Constructed by admiralpeds developers
Vital Signs for Vaccine
Description
An example SDTM VS dataset for vaccine studies
Usage
vs_vaccine
Format
A data frame with 23 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- VSSEQ
Sequence Number
- VSLNKID
Link ID
- VSLNKGRP
Link Group ID
- VSTESTCD
Vital Signs Test Short Name
- VSTEST
Vital Signs Test Name
- VSCAT
Category for Vital Signs
- VSSCAT
Subcategory for Vital Signs
- VSORRES
Result or Finding in Original Units
- VSORRESU
Original Units
- VSSTRESC
Character Result/Finding in Std Format
- VSSTRESN
Numeric Result/Finding in Standard Units
- VSSTRESU
Standard Units
- VSEVAL
Evaluator
- VSLOC
Location of Vital Signs Measurement
- EPOCH
Epoch
- VSDTC
Date/Time of Measurements
- VSDY
Study Day of Vital Signs
- VSTPT
Planned Time Point Name
- VSTPTNUM
Planned Time Point Number
- VSTPTREF
Time Point Reference
Details
Vital Signs for Vaccine
An example SDTM VS dataset for vaccine studies
Contains a set of 1 unique Test Short Name and Test Name:
| VSTESTCD | VSTEST |
| TEMP | Temperature |
Source
Constructed by admiralvaccine developers