| Type: | Package |
| Title: | Raw Data for 'pharmaversesdtm' Package |
| Version: | 0.1.1 |
| Description: | A set of raw datasets used to create SDTM domains in 'pharmaversesdtm' package. |
| License: | Apache License (≥ 2.0) |
| URL: | https://pharmaverse.github.io/pharmaverseraw/, https://github.com/pharmaverse/pharmaverseraw/ |
| Depends: | R (≥ 4.1) |
| Suggests: | covr, devtools, knitr, lintr, pkgdown, rmarkdown, roxygen2, spelling, testthat, usethis, pharmaversesdtm (≥ 0.2.0) |
| Encoding: | UTF-8 |
| Language: | en-US |
| LazyData: | true |
| RoxygenNote: | 7.3.2 |
| NeedsCompilation: | no |
| Packaged: | 2025-08-30 02:47:28 UTC; r2846492 |
| Author: | Rammprasad Ganapathy [aut, cre], Shiyu Chen [aut] |
| Maintainer: | Rammprasad Ganapathy <ganapathy.rammprasad@gene.com> |
| Repository: | CRAN |
| Date/Publication: | 2025-08-30 03:10:02 UTC |
Adverse Events Raw Dataset
Description
A raw dataset used to create pharmaversesdtm::ae
Usage
ae_raw
Format
A data frame with 32 columns:
- STUDY
Study Identifier
- PATNUM
Patient Number
- FOLDER
Folder
- FOLDERL
Folder Label
- IT.AETERM
Reported Term for the Adverse Event
- AEOUTCOME
Outcome of 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
- IT.AESEV
Severity/Intensity
- IT.AESER
Serious Event
- IT.AEREL
Causality
- IT.AEACN
Action Taken with Study Treatment
- AESCAN
Involves Cancer
- AESCNO
Congenital Anomaly or Birth Defect
- AEDIS
Persist or Signif Disability/Incapacity
- IT.AESDTH
Results in Death
- IT.AESHOSP
Requires or Prolongs Hospitalization
- IT.AESLIFE
Is Life Threatening
- AESOD
Occurred with Overdose
- AEDTCOL
Date/Time of Collection
- IT.AESTDAT
Start Date/Time of Adverse Event
- IT.AEENDAT
End Date/Time of Adverse Event
Details
Adverse Events
A raw dataset used to create pharmaversesdtm::ae
Author(s)
Shiyu Chen
Source
Access the source of the adverse events dataset.
Demographics Raw Dataset
Description
A raw dataset used to create pharmaversesdtm::dm
Usage
dm_raw
Format
A data frame with 13 columns:
- STUDY
Study Identifier
- PATNUM
Patient Number
- IT.AGE
Age
- IT.SEX
Sex
- IT.ETHNIC
Ethnicity
- IT.RACE
Race
- COUNTRY
Country
- PLANNED_ARM
Planned Arm
- PLANNED_ARMCD
Planned Arm Code
- ACTUAL_ARM
Actual Arm
- ACTUAL_ARMCD
Actual Arm Code
- COL_DT
Date of Collection
- IC_DT
Date of Informed Consent
Details
Demographics
A raw dataset used to create pharmaversesdtm::dm
Author(s)
Shiyu Chen
Source
Access the source of the demographics dataset.
Subject Disposition Raw Dataset
Description
A raw dataset used to create pharmaversesdtm::ds
Usage
ds_raw
Format
A data frame with 13 columns:
- STUDY
Study Identifier
- PATNUM
Patient Number
- SITENM
Site Name
- INSTANCE
Instance
- FORM
Form
- FORML
Form Label
- IT.DSTERM
Reason for Discontinuation
- IT.DSDECOD
Discontinuation Code
- OTHERSP
Other Reason for Discontinuation
- DSDTCOL
Date of Collection
- DSTMCOL
Time of Collection
- IT.DSSTDAT
Start Date of Subject Disposition
- DEATHDT
Death Date of Subject
Details
Subject Disposition
A raw dataset used to create pharmaversesdtm::ds
Author(s)
Shiyu Chen
Source
Access the source of the subject disposition dataset.
Exposure as Collected Raw Dataset
Description
A raw dataset used to create pharmaversesdtm::ex
Usage
ec_raw
Format
A data frame with 14 columns:
- STUDY
Study Identifier
- PATNUM
Patient Number
- VISITNAME
Visit Name
- FOLDER
Folder
- FOLDERL
Folder Label
- IT.ECREFID
Study Treatment Label Identifier
- DRUGAD
Drug Administered
- IT.ECSTDAT
Study Treatment Start Date
- IT.ECENDAT
Study Treatment End Date
- IT.ECDSTXT
Dose of Study Treatment
- IT.ECDOSU
Dose Unit of Study Treatment
- DOSFM
Dose Form of Study Treatment
- DOSFRQ
Dose Frequency of Study Treatment
- IT.ECROUTE
Route of Administration
Details
Exposure as Collected
A raw dataset used to create pharmaversesdtm::ex
Author(s)
Shiyu Chen
Source
Access the source of the exposure as collected dataset.
Vital Signs Raw Dataset
Description
A raw dataset used to create pharmaversesdtm::vs
Usage
vs_raw
Format
A data frame with 15 columns:
- STUDY
Study Identifier
- PATNUM
Patient Number
- INSTANCE
Folder
- FORM
Form
- FORML
Form Label
- VTLD
Vital Signs Collection Date
- IT.HEIGHT_VSORRES
Height
- IT.WEIGHT
Weight
- IT.TEMP
Temperature
- IT.TEMP_LOC
Temperature Location
- TMPTC
Timepoint
- SYS_BP
Systolic Blood Pressure
- DIA_BP
Diastolic Blood Pressure
- PULSE
Pulse
- SUBPOS
Subject Position
Details
Vital Signs
A raw dataset used to create pharmaversesdtm::vs
Author(s)
Shiyu Chen & Rammprasad Ganapathy