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Title: Clinical Trial Data
Description: Example clinical trial data sets formatted for easy use in R.
Version: 1.0.0
License: MIT + file LICENSE
Encoding: UTF-8
LazyData: true
RoxygenNote: 7.1.1
Depends: R (≥ 3.0)
NeedsCompilation: no
Packaged: 2021-01-15 19:37:09 UTC; jeremy
Author: Jeremy Wildfire [aut, cre], Renan Escalante Chong [aut]
Maintainer: Jeremy Wildfire <jwildfire@gmail.com>
Repository: CRAN
Date/Publication: 2021-01-19 09:50:02 UTC

adam_adae

Description

ADaM adae data frame

Usage

adam_adae

Format

a data frame with 1191 rows and 55 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/adam/README.md for more details and full data specification.

adam_adlbc

Description

ADaM adlbc data frame

Usage

adam_adlbc

Format

a data frame with 74264 rows and 46 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/adam/README.md for more details and full data specification.

adam_adlbh

Description

ADaM adlbh data frame

Usage

adam_adlbh

Format

a data frame with 49932 rows and 46 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/adam/README.md for more details and full data specification.

adam_adlbhy

Description

ADaM adlbhy data frame

Usage

adam_adlbhy

Format

a data frame with 9954 rows and 43 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/adam/README.md for more details and full data specification.

adam_adqsadas

Description

ADaM adqsadas data frame

Usage

adam_adqsadas

Format

a data frame with 12463 rows and 40 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/adam/README.md for more details and full data specification.

adam_adqscibc

Description

ADaM adqscibc data frame

Usage

adam_adqscibc

Format

a data frame with 730 rows and 36 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/adam/README.md for more details and full data specification.

adam_adqsnpix

Description

ADaM adqsnpix data frame

Usage

adam_adqsnpix

Format

a data frame with 31140 rows and 41 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/adam/README.md for more details and full data specification.

adam_adsl

Description

ADaM adsl data frame

Usage

adam_adsl

Format

a data frame with 254 rows and 48 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/adam/README.md for more details and full data specification.

adam_adtte

Description

ADaM adtte data frame

Usage

adam_adtte

Format

a data frame with 254 rows and 26 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/adam/README.md for more details and full data specification.

adam_advs

Description

ADaM advs data frame

Usage

adam_advs

Format

a data frame with 32139 rows and 34 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/adam/README.md for more details and full data specification.

sdtm_ae

Description

Adverse Events data frame - One record per adverse event per subject

Usage

sdtm_ae

Format

a data frame with 1191 rows and 35 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

DOMAIN

text - Domain Abbreviation

USUBJID

text - Unique Subject Identifier

AESEQ

integer - Sequence Number

AESPID

text - Sponsor-Defined Identifier

AETERM

text - Reported Term for the Adverse Event

AELLT

text - Lowest Level Term

AELLTCD

integer - Lowest Level Term Code

AEDECOD

text - Dictionary-Derived Term

AEPTCD

integer - Preferred Term Code

AEHLT

text - High Level Term

AEHLTCD

integer - High Level Term Code

AEHLGT

text - High Level Group Term

AEHLGTCD

integer - High Level Group Term Code

AEBODSYS

text - Body System or Organ Class

AEBDSYCD

integer - Body System or Organ Class Code

AESOC

text - Primary System Organ Class

AESOCCD

integer - Primary System Organ Class Code

AESEV

text - Severity/Intensity

AESER

text - Serious Event

AEACN

text - Action Taken with Study Treatment

AEREL

text - Causality

AEOUT

text - Outcome of Adverse Event

AESCAN

text - Involves Cancer

AESCONG

text - Congenital Anomaly or Birth Defect

AESDISAB

text - Persist or Signif Disability/Incapacity

AESDTH

text - Results in Death

AESHOSP

text - Requires or Prolongs Hospitalization

AESLIFE

text - Is Life Threatening

AESOD

text - Occurred with Overdose

AEDTC

date - Date/Time of Collection

AESTDTC

date - Start Date/Time of Adverse Event

AEENDTC

date - End Date/Time of Adverse Event

AESTDY

integer - Study Day of Start of Adverse Event

AEENDY

integer - Study Day of End of Adverse Event

sdtm_cm

Description

Concomitant Medications data frame - One record per recorded medication occurrence or constant-dosing interval per subject

Usage

sdtm_cm

Format

a data frame with 7510 rows and 21 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

DOMAIN

text - Domain Abbreviation

USUBJID

text - Unique Subject Identifier

CMSEQ

integer - Sequence Number

CMSPID

text - Sponsor-Defined Identifier

CMTRT

text - Reported Name of Drug, Med, or Therapy

CMDECOD

text - Standardized Medication Name

CMINDC

text - Indication

CMCLAS

text - Medication Class

CMDOSE

integer - Dose per Administration

CMDOSU

text - Dose Units

CMDOSFRQ

text - Dosing Frequency per Interval

CMROUTE

text - Route of Administration

VISITNUM

float - Visit Number

VISIT

text - Visit Name

VISITDY

integer - Planned Study Day of Visit

CMDTC

date - Date/Time of Collection

CMSTDTC

date - Start Date/Time of Medication

CMENDTC

date - End Date/Time of Medication

CMSTDY

integer - Study Day of Start of Medication

CMENDY

integer - Study Day of End of Medication

sdtm_dm

Description

Demographics data frame - One record per subject

Usage

sdtm_dm

Format

a data frame with 306 rows and 25 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

DOMAIN

text - Domain Abbreviation

USUBJID

text - Unique Subject Identifier

SUBJID

text - Subject Identifier for the Study

RFSTDTC

date - Subject Reference Start Date/Time

RFENDTC

date - Subject Reference End Date/Time

RFXSTDTC

datetime - Date/Time of First Study Treatment

RFXENDTC

datetime - Date/Time of Last Study Treatment

RFICDTC

datetime - Date/Time of Informed Consent

RFPENDTC

datetime - Date/Time of End of Participation

DTHDTC

datetime - Date/Time of Death

DTHFL

text - Subject Death Flag

SITEID

text - Study Site Identifier

AGE

integer - Age

AGEU

text - Age Units

SEX

text - Sex

RACE

text - Race

ETHNIC

text - Ethnicity

ARMCD

text - Planned Arm Code

ARM

text - Description of Planned Arm

ACTARMCD

text - Actual Arm Code

ACTARM

text - Description of Actual Arm

COUNTRY

text - Country

DMDTC

date - Date/Time of Collection

DMDY

integer - Study Day of Collection

sdtm_ds

Description

Disposition data frame - One record per disposition status or protocol milestone per subject

Usage

sdtm_ds

Format

a data frame with 596 rows and 13 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

DOMAIN

text - Domain Abbreviation

USUBJID

text - Unique Subject Identifier

DSSEQ

integer - Sequence Number

DSSPID

text - Sponsor-Defined Identifier

DSTERM

text - Reported Term for the Disposition Event

DSDECOD

text - Standardized Disposition Term

DSCAT

text - Category for Disposition Event

VISITNUM

float - Visit Number

VISIT

text - Visit Name

DSDTC

datetime - Date/Time of Collection

DSSTDTC

date - Start Date/Time of Disposition Event

DSSTDY

integer - Study Day of Start of Disposition Event

sdtm_ex

Description

Exposure data frame - One record per constant dosing interval per subject

Usage

sdtm_ex

Format

a data frame with 591 rows and 17 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

DOMAIN

text - Domain Abbreviation

USUBJID

text - Unique Subject Identifier

EXSEQ

integer - Sequence Number

EXTRT

text - Name of Actual Treatment

EXDOSE

integer - Dose per Administration

EXDOSU

text - Dose Units

EXDOSFRM

text - Dose Form

EXDOSFRQ

text - Dosing Frequency per Interval

EXROUTE

text - Route of Administration

VISITNUM

float - Visit Number

VISIT

text - Visit Name

VISITDY

integer - Planned Study Day of Visit

EXSTDTC

date - Start Date/Time of Treatment

EXENDTC

date - End Date/Time of Treatment

EXSTDY

integer - Study Day of Start of Treatment

EXENDY

integer - Study Day of End of Treatment

sdtm_lb

Description

Laboratory Tests Results data frame - One record per analyte per planned time point number per time point reference per visit per subject

Usage

sdtm_lb

Format

a data frame with 59580 rows and 23 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

DOMAIN

text - Domain Abbreviation

USUBJID

text - Unique Subject Identifier

LBSEQ

integer - Sequence Number

LBTESTCD

text - Lab Test or Examination Short Name

LBTEST

text - Lab Test or Examination Name

LBCAT

text - Category for Lab Test

LBORRES

text - Result or Finding in Original Units

LBORRESU

text - Original Units

LBORNRLO

text - Reference Range Lower Limit in Orig Unit

LBORNRHI

text - Reference Range Upper Limit in Orig Unit

LBSTRESC

text - Character Result/Finding in Std Format

LBSTRESN

integer - Numeric Result/Finding in Standard Units

LBSTRESU

text - Standard Units

LBSTNRLO

integer - Reference Range Lower Limit-Std Units

LBSTNRHI

integer - Reference Range Upper Limit-Std Units

LBNRIND

text - Reference Range Indicator

LBBLFL

text - Baseline Flag

VISITNUM

float - Visit Number

VISIT

text - Visit Name

VISITDY

integer - Planned Study Day of Visit

LBDTC

datetime - Date/Time of Specimen Collection

LBDY

integer - Study Day of Specimen Collection

sdtm_mh

Description

Medical History data frame - One record per medical history event per subject

Usage

sdtm_mh

Format

a data frame with 1818 rows and 19 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

DOMAIN

text - Domain Abbreviation

USUBJID

text - Unique Subject Identifier

MHSEQ

integer - Sequence Number

MHSPID

text - Sponsor-Defined Identifier

MHTERM

text - Reported Term for the Medical History

MHLLT

text - Lowest Level Term

MHDECOD

text - Dictionary-Derived Term

MHHLT

text - High Level Term

MHHLGT

text - High Level Group Term

MHCAT

text - Category for Medical History

MHBODSYS

text - Body System or Organ Class

MHSEV

text - Severity/Intensity

VISITNUM

float - Visit Number

VISIT

text - Visit Name

VISITDY

integer - Planned Study Day of Visit

MHDTC

date - Date/Time of History Collection

MHSTDTC

date - Start Date/Time of Medical History Event

MHDY

integer - Study Day of History Collection

sdtm_qs

Description

Questionnaires data frame - One record per questionnaire per question per time point per visit per subject

Usage

sdtm_qs

Format

a data frame with 121749 rows and 20 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

DOMAIN

text - Domain Abbreviation

USUBJID

text - Unique Subject Identifier

QSSEQ

integer - Sequence Number

QSTESTCD

text - Question Short Name

QSTEST

text - Question Name

QSCAT

text - Category of Question

QSSCAT

text - Subcategory for Question

QSORRES

text - Finding in Original Units

QSORRESU

text - Original Units

QSSTRESC

text - Character Result/Finding in Std Format

QSSTRESN

integer - Numeric Finding in Standard Units

QSSTRESU

text - Standard Units

QSBLFL

text - Baseline Flag

QSDRVFL

text - Derived Flag

VISITNUM

float - Visit Number

VISIT

text - Visit Name

VISITDY

integer - Planned Study Day of Visit

QSDTC

date - Date/Time of Finding

QSDY

integer - Study Day of Finding

sdtm_relrec

Description

Related Records data frame - One record per related record, group of records or datasets

Usage

sdtm_relrec

Format

a data frame with 234 rows and 7 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

RDOMAIN

text - Related Domain Abbreviation

USUBJID

text - Unique Subject Identifier

IDVAR

text - Identifying Variable

IDVARVAL

text - Identifying Variable Value

RELTYPE

text - Relationship Type

RELID

text - Relationship Identifier

sdtm_sc

Description

Subject Characteristics data frame - One record per characteristic per subject

Usage

sdtm_sc

Format

a data frame with 254 rows and 14 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

DOMAIN

text - Domain Abbreviation

USUBJID

text - Unique Subject Identifier

SCSEQ

integer - Sequence Number

SCTESTCD

text - Subject Characteristic Short Name

SCTEST

text - Subject Characteristic

SCCAT

text - Category for Subject Characteristic

SCORRES

text - Result or Finding in Original Units

SCORRESU

text - Original Units

SCSTRESC

text - Character Result/Finding in Std Format

SCSTRESN

integer - Numeric Result/Finding in Standard Units

SCSTRESU

text - Standard Units

SCDTC

date - Date/Time of Collection

SCDY

integer - Study Day of Examination

sdtm_se

Description

Subject Elements data frame - One record per actual Element per subject

Usage

sdtm_se

Format

a data frame with 752 rows and 9 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

DOMAIN

text - Domain Abbreviation

USUBJID

text - Unique Subject Identifier

SESEQ

integer - Sequence Number

ETCD

text - Element Code

ELEMENT

text - Description of Element

SESTDTC

date - Start Date/Time of Element

SEENDTC

date - End Date/Time of Element

SEUPDES

text - Description of Unplanned Element

sdtm_suppae

Description

Supplemental Qualifiers for AE data frame - One record per IDVAR, IDVARVAL, and QNAM value per subject

Usage

sdtm_suppae

Format

a data frame with 1191 rows and 10 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

RDOMAIN

text - Related Domain Abbreviation

USUBJID

text - Unique Subject Identifier

IDVAR

text - Identifying Variable

IDVARVAL

text - Identifying Variable Value

QNAM

text - Qualifier Variable Name

QLABEL

text - Qualifier Variable Label

QVAL

text - Data Value

QORIG

text - Origin

QEVAL

text - Evaluator

sdtm_suppdm

Description

Supplemental Qualifiers for DM data frame - One record per IDVAR, IDVARVAL, and QNAM value per subject

Usage

sdtm_suppdm

Format

a data frame with 1197 rows and 10 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

RDOMAIN

text - Related Domain Abbreviation

USUBJID

text - Unique Subject Identifier

IDVAR

text - Identifying Variable

IDVARVAL

text - Identifying Variable Value

QNAM

text - Qualifier Variable Name

QLABEL

text - Qualifier Variable Label

QVAL

text - Data Value

QORIG

text - Origin

QEVAL

text - Evaluator

sdtm_suppds

Description

Supplemental Qualifiers for DS data frame - One record per IDVAR, IDVARVAL, and QNAM value per subject

Usage

sdtm_suppds

Format

a data frame with 3 rows and 10 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

RDOMAIN

text - Related Domain Abbreviation

USUBJID

text - Unique Subject Identifier

IDVAR

text - Identifying Variable

IDVARVAL

text - Identifying Variable Value

QNAM

text - Qualifier Variable Name

QLABEL

text - Qualifier Variable Label

QVAL

text - Data Value

QORIG

text - Origin

QEVAL

text - Evaluator

sdtm_supplb

Description

Supplemental Qualifiers for LB data frame - One record per IDVAR, IDVARVAL, and QNAM value per subject

Usage

sdtm_supplb

Format

a data frame with 64403 rows and 10 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

RDOMAIN

text - Related Domain Abbreviation

USUBJID

text - Unique Subject Identifier

IDVAR

text - Identifying Variable

IDVARVAL

text - Identifying Variable Value

QNAM

text - Qualifier Variable Name

QLABEL

text - Qualifier Variable Label

QVAL

text - Data Value

QORIG

text - Origin

QEVAL

text - Evaluator

sdtm_sv

Description

Subject Visits data frame - One record per actual visit per subject

Usage

sdtm_sv

Format

a data frame with 3559 rows and 8 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

DOMAIN

text - Domain Abbreviation

USUBJID

text - Unique Subject Identifier

VISITNUM

float - Visit Number

VISIT

text - Visit Name

VISITDY

integer - Planned Study Day of Visit

SVSTDTC

date - Start Date/Time of Visit

SVENDTC

date - End Date/Time of Visit

sdtm_ta

Description

Trial Arms data frame - One record per planned Element per Arm

Usage

sdtm_ta

Format

a data frame with 8 rows and 10 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

DOMAIN

text - Domain Abbreviation

ARMCD

text - Planned Arm Code

ARM

text - Description of Planned Arm

TAETORD

integer - Order of Element within Arm

ETCD

text - Element Code

ELEMENT

text - Description of Element

TABRANCH

text - Branch

TATRANS

text - Transition Rule

EPOCH

text - Epoch

sdtm_te

Description

Trial Elements data frame - One record per planned Element

Usage

sdtm_te

Format

a data frame with 7 rows and 7 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

DOMAIN

text - Domain Abbreviation

ETCD

text - Element Code

ELEMENT

text - Description of Element

TESTRL

text - Rule for Start of Element

TEENRL

text - Rule for End of Element

TEDUR

text - Planned Duration of Element

sdtm_ti

Description

Trial Inclusion/ Exclusion Criteria data frame - One record per I/E criterion

Usage

sdtm_ti

Format

a data frame with 31 rows and 6 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

DOMAIN

text - Domain Abbreviation

IETESTCD

text - Incl/Excl Criterion Short Name

IETEST

text - Inclusion/Exclusion Criterion

IECAT

text - Inclusion/Exclusion Category

TIRL

text - Inclusion/Exclusion Criterion Rule

sdtm_ts

Description

Trial Summary data frame - One record per trial summary parameter value

Usage

sdtm_ts

Format

a data frame with 33 rows and 6 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

DOMAIN

text - Domain Abbreviation

TSSEQ

integer - Sequence Number

TSPARMCD

text - Trial Summary Parameter Short Name

TSPARM

text - Trial Summary Parameter

TSVAL

text - Parameter Value

sdtm_tv

Description

Trial Visits data frame - One record per planned Visit per Arm

Usage

sdtm_tv

Format

a data frame with 21 rows and 9 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

DOMAIN

text - Domain Abbreviation

VISITNUM

float - Visit Number

VISIT

text - Visit Name

VISITDY

integer - Planned Study Day of Visit

ARMCD

text - Planned Arm Code

ARM

text - Description of Planned Arm

TVSTRL

text - Visit Start Rule

TVENRL

text - Visit End Rule

sdtm_vs

Description

Vital Signs data frame - One record per vital sign measurement per time point per visit per subject

Usage

sdtm_vs

Format

a data frame with 29643 rows and 24 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

DOMAIN

text - Domain Abbreviation

USUBJID

text - Unique Subject Identifier

VSSEQ

integer - Sequence Number

VSTESTCD

text - Vital Signs Test Short Name

VSTEST

text - Vital Signs Test Name

VSPOS

text - Vital Signs Position of Subject

VSORRES

text - Result or Finding in Original Units

VSORRESU

text - Original Units

VSSTRESC

text - Character Result/Finding in Std Format

VSSTRESN

integer - Numeric Result/Finding in Standard Units

VSSTRESU

text - Standard Units

VSSTAT

text - Completion Status

VSLOC

text - Location of Vital Signs Measurement

VSBLFL

text - Baseline Flag

VISITNUM

float - Visit Number

VISIT

text - Visit Name

VISITDY

integer - Planned Study Day of Visit

VSDTC

date - Date/Time of Measurements

VSDY

integer - Study Day of Vital Signs

VSTPT

text - Planned Time Point Name

VSTPTNUM

integer - Planned Time Point Number

VSELTM

text - Planned Elapsed Time from Time Point Ref

VSTPTREF

text - Time Point Reference

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