| Title: | J&J Innovative Medicine SDTM Test Data |
|---|---|
| Description: | A set of Study Data Tabulation Model (SDTM) datasets constructed by modifying the 'pharmaversesdtm' package to meet J&J Innovative Medicine's standard data structure for Clinical and Statistical Programming. |
| Authors: | David Munoz Tord [aut, cre], Nicholas Masel [aut], Joe Kovach [aut], Renfei Mao [ctb], J&J Innovative Medicine [cph, fnd] |
| Maintainer: | David Munoz Tord <[email protected]> |
| License: | Apache License (>= 2.0) |
| Version: | 0.0.6 |
| Built: | 2026-09-23 20:53:35 UTC |
| Source: | https://github.com/cran/pharmaversesdtmjnj |
ae modified from pharmaversesdtm
aeae
A data frame with 1191 rows and 36 variables:
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
End Relative to Reference Time Point
data from pharmaversesdtm.
ae ds dv ho ie mh pr suppho supppc supppr ts
head(data("ae"))head(data("ae"))
ds modified from pharmaversesdtm
dsds
A data frame with 850 rows and 14 variables:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Sponsor-Defined Identifier
Reported Term for the Disposition Event
Standardized Disposition Term
Category for Disposition Event
Visit Number
Visit Name
Date/Time of Collection
Start Date/Time of Disposition Event
Study Day of Start of Disposition Event
Subcategory for Disposition Event
data from pharmaversesdtm.
ae ds dv ho ie mh pr suppho supppc supppr ts
head(data("ds"))head(data("ds"))
dv created from scratch
dvdv
A data frame with 75 rows and 8 variables:
Study Identifier
Unique Subject Identifier
Domain Abbreviation
Sequence Number
Protocol Deviation Term
Standardized Deviation Term
Protocol Deviation Category
Start Date/Time of Protocol Deviation
ae ds dv ho ie mh pr suppho supppc supppr ts
head(data("dv"))head(data("dv"))
ho created from scratch
hoho
A data frame with 1191 rows and 13 variables:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Healthcare Encounter Term
Start Date/Time of Healthcare Encounter
Study Day of Start of Encounter
End Date/Time of Healthcare Encounter
Study Day of End of Healthcare Encounter
End Relative to Reference Time Point
End Relative to Reference Period
Duration of Healthcare Encounter
Healthcare Encounter Occurrence
ae ds dv ho ie mh pr suppho supppc supppr ts
head(data("ho"))head(data("ho"))
ie modified from pharmaversesdtm
ieie
A data frame with 60 rows and 12 variables:
Study Identifier
Unique Subject Identifier
Visit Name
Visit Number
Domain Abbreviation
Sequence Number
Inclusion/Exclusion Category
Inclusion/Exclusion Criterion Test Name
Inclusion/Exclusion Criterion Short Name
Result or Finding in Original Units
Character Result Standard Format
Date/Time of Collection
data from pharmaversesdtm.
ae ds dv ho ie mh pr suppho supppc supppr ts
head(data("ie"))head(data("ie"))
mh modified from pharmaversesdtm
mhmh
A data frame with 1818 rows and 31 variables:
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
Standard Toxicity Grade
Study Day of Start of Medical History
Study Day of End of Medical History
data from pharmaversesdtm.
ae ds dv ho ie mh pr suppho supppc supppr ts
head(data("mh"))head(data("mh"))
pr created from scratch
prpr
A data frame with 80 rows and 11 variables:
STUDYID
DOMAIN
USUBJID
Sequence Number
Therapeutic or Diagnostic Procedure
Standardized Procedure Name
Indication
Prior Intervention
Start Date/Time of Procedure
End Date/Time of Procedure
Duration of Procedure
ae ds dv ho ie mh pr suppho supppc supppr ts
head(data("pr"))head(data("pr"))
suppho created from scratch
supphosuppho
A data frame with 5955 rows and 8 variables:
Study Identifier
Related Domain
Unique Subject Identifier
Identifying Variable
Identifying Variable Value
Qualifier Variable Name
Qualifier Variable Label
Qualifier Value
ae ds dv ho ie mh pr suppho supppc supppr ts
head(data("suppho"))head(data("suppho"))
supppc modified from pharmaversesdtm
supppcsupppc
A data frame with 4572 rows and 8 variables:
Study Identifier
Related Domain Abbreviation
Unique Subject Identifier
Identifying Variable
Identifying Variable Value
Qualifier Variable Name
Qualifier Variable Label
Qualifier Value
data from pharmaversesdtm.
ae ds dv ho ie mh pr suppho supppc supppr ts
head(data("supppc"))head(data("supppc"))
supppr created from scratch
suppprsupppr
A data frame with 240 rows and 8 variables:
Study Identifier
Related Domain Abbreviation
Unique Subject Identifier
Identifying Variable
Identifying Variable Value
Qualifier Variable Name
Qualifier Variable Label
Qualifier Value
ae ds dv ho ie mh pr suppho supppc supppr ts
head(data("supppr"))head(data("supppr"))
ts modified from pharmaversesdtm
tsts
A data frame with 33 rows and 6 variables:
Study Identifier
Domain Abbreviation
Sequence Number
Trial Summary Parameter Short Name
Trial Summary Parameter
Parameter Value
data from pharmaversesdtm.
ae ds dv ho ie mh pr suppho supppc supppr ts
head(data("ts"))head(data("ts"))