Package {pharmaversesdtmjnj}

pharmaversesdtmjnj: 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.

Author(s)

Maintainer: David Munoz Tord david.munoztord@mailbox.org

Authors:

• Nicholas Masel nmasel@its.jnj.com

• Joe Kovach jkovach2@its.jnj.com

Other contributors:

• Renfei Mao rmao6@its.jnj.com [contributor]

• J&J Innovative Medicine [copyright holder, funder]

ae

Description

ae modified from pharmaversesdtm

Usage

ae

Format

A data frame with 1191 rows and 36 variables:

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

AEENRTPT

End Relative to Reference Time Point

Source

data from pharmaversesdtm.

See Also

ae ds dv ho ie mh suppho ts

Examples

 head(data("ae"))

ds

Description

ds modified from pharmaversesdtm

Usage

ds

Format

A data frame with 850 rows and 14 variables:

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

DSSCAT

Subcategory for Disposition Event

Source

data from pharmaversesdtm.

See Also

ae ds dv ho ie mh suppho ts

Examples

 head(data("ds"))

dv

Description

dv modified from pharmaversesdtm

Usage

dv

Format

A data frame with 75 rows and 17 variables:

STUDYID

Study Identifier

USUBJID

Unique Subject Identifier

TRTSDTM

Datetime of First Exposure to Treatment

TRTEDTM

Datetime of Last Exposure to Treatment

DOMAIN

Domain Abbreviation

DVSEQ

Sequence Number

DVTERM

Protocol Deviation Term

DVDECOD

DVDECOD

DVCAT

DVCAT

DVSCAT

Subcategory for Protocol Deviation

DVREAS

Reason for Deviation

DVEPRELI

Epi/Pandemic Related Indicator

ASTDT

Analysis Start Date

ASTDY

Analysis Start Relative Day

AEPRELFL

Analysis Epi/Pandemic Related Flag

TRTSDT

Date of First Exposure to Treatment

DVSTDTC

Date of First Exposure to Treatment

Source

data from pharmaversesdtm.

See Also

ae ds dv ho ie mh suppho ts

Examples

 head(data("dv"))

ho

Description

ho modified from pharmaversesdtm

Usage

ho

Format

A data frame with 1191 rows and 12 variables:

STUDYID

Study Identifier

USUBJID

Unique Subject Identifier

HOSEQ

Sequence Number

HOTERM

Healthcare Encounter Term

HOSTDTC

Start Date/Time of Healthcare Encounter

HOSTDY

Study Day of Start of Encounter

HOENDTC

End Date/Time of Healthcare Encounter

HOENDY

Study Day of End of Healthcare Encounter

HOENRTPT

End Relative to Reference Time Point

HOENRF

End Relative to Reference Period

HODUR

Duration of Healthcare Encounter

HOOCCUR

Healthcare Encounter Occurrence

Source

data from pharmaversesdtm.

See Also

ae ds dv ho ie mh suppho ts

Examples

 head(data("ho"))

ie

Description

ie modified from pharmaversesdtm

Usage

ie

Format

A data frame with 60 rows and 4 variables:

STUDYID

Study Identifier

USUBJID

Unique Subject Identifier

IECAT

IE Category

IETEST

IE Criterion Test Name

Source

data from pharmaversesdtm.

See Also

ae ds dv ho ie mh suppho ts

Examples

 head(data("ie"))

mh

Description

mh modified from pharmaversesdtm

Usage

mh

Format

A data frame with 1818 rows and 31 variables:

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

MHTOXGR

Standard Toxicity Grade

MHSTDY

Study Day of Start of Medical History

MHENDY

Study Day of End of Medical History

Source

data from pharmaversesdtm.

See Also

ae ds dv ho ie mh suppho ts

Examples

 head(data("mh"))

suppho

Description

suppho modified from pharmaversesdtm

Usage

suppho

Format

A data frame with 5955 rows and 8 variables:

STUDYID

Study Identifier

RDOMAIN

Related Domain

USUBJID

Unique Subject Identifier

IDVAR

Identifying Variable

IDVARVAL

Identifying Variable Value

QNAM

Qualifier Variable Name

QLABEL

Qualifier Variable Label

QVAL

Qualifier Value

Source

data from pharmaversesdtm.

See Also

ae ds dv ho ie mh suppho ts

Examples

 head(data("suppho"))

ts

Description

ts modified from pharmaversesdtm

Usage

ts

Format

A data frame with 33 rows and 6 variables:

STUDYID

Study Identifier

DOMAIN

Domain Abbreviation

TSSEQ

Sequence Number

TSPARMCD

Trial Summary Parameter Short Name

TSPARM

Trial Summary Parameter

TSVAL

Parameter Value

Source

data from pharmaversesdtm.

See Also

ae ds dv ho ie mh suppho ts

Examples

 head(data("ts"))