Package 'pharmaversesdtm'

Title: 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: CDISC Submission Data Standards Team (2021) <https://www.cdisc.org/system/files/members/standard/foundational/SDTMIG%20v3.4-FINAL_2022-07-21.pdf>.
Authors: Edoardo Mancini [aut, cre] , Gayatri G [aut], Kangjie Zhang [aut], Pooja Kumari [aut], Stefan Bundfuss [aut] , Zelos Zhu [aut], Sadchla Mascary [aut], Vladyslav Shuliar [aut]
Maintainer: Edoardo Mancini <[email protected]>
License: Apache License (>= 2.0)
Version: 1.0.0
Built: 2024-10-16 14:16:39 UTC
Source: https://github.com/pharmaverse/pharmaversesdtm

Help Index


Adverse Events

Description

An updated SDTM AE dataset that uses the CDISC pilot project

Usage

ae

Format

An object of class tbl_df (inherits from tbl, data.frame) with 1191 rows and 35 columns.

Source

https://github.com/pharmaverse/pharmaversesdtm/blob/main/data/ae.rda


Adverse Events for Ophthalmology

Description

An example Adverse Events SDTM dataset with ophthalmology-specific variable AELAT

Usage

ae_ophtha

Format

An object of class tbl_df (inherits from tbl, data.frame) with 1191 rows and 36 columns.

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

An object of class tbl_df (inherits from tbl, data.frame) with 44 rows and 29 columns.

Source

Constructed by {admiralvaccine} developers


Concomitant Medication

Description

A SDTM CM dataset from the CDISC pilot project

Usage

cm

Format

An object of class tbl_df (inherits from tbl, data.frame) with 7510 rows and 22 columns.

Source

https://github.com/cdisc-org/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/tabulations/sdtm/cm.xpt?raw=true # nolint


Demography

Description

A SDTM DM dataset from the CDISC pilot project

Usage

dm

Format

An object of class tbl_df (inherits from tbl, data.frame) with 306 rows and 25 columns.

Source

https://github.com/cdisc-org/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/tabulations/sdtm/dm.xpt?raw=true # nolint


Demographic Dataset-pediatrics

Description

An updated SDTM DM dataset with pediatric patients

Usage

dm_peds

Format

An object of class tbl_df (inherits from tbl, data.frame) with 5 rows and 26 columns.

Source

Constructed by {admiralpeds} developers


Demographics for Vaccine

Description

An example SDTM DM dataset for vaccine studies

Usage

dm_vaccine

Format

An object of class tbl_df (inherits from tbl, data.frame) with 2 rows and 28 columns.

Source

Constructed by {admiralvaccine} developers


Disposition

Description

An updated SDTM DS dataset that uses the CDISC pilot project

Usage

ds

Format

An object of class tbl_df (inherits from tbl, data.frame) with 850 rows and 13 columns.

Author(s)

Gopi Vegesna

Source

https://github.com/pharmaverse/pharmaversesdtm/blob/main/data/ds.rda


Electrocardiogram

Description

An example of standard SDTM EG dataset to be used in deriving ADEG dataset

Usage

eg

Format

An object of class tbl_df (inherits from tbl, data.frame) with 26717 rows and 23 columns.


Exposure

Description

A SDTM EX dataset from the CDISC pilot project

Usage

ex

Format

An object of class tbl_df (inherits from tbl, data.frame) with 591 rows and 17 columns.

Source

https://github.com/cdisc-org/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/tabulations/sdtm/ex.xpt?raw=true # nolint


Exposure for Ophthalmology

Description

An example Exposure SDTM dataset with ophthalmology-specific variables such as EXLOC and EXLAT

Usage

ex_ophtha

Format

An object of class tbl_df (inherits from tbl, data.frame) with 591 rows and 19 columns.

Source

Constructed using ex from the {pharmaversesdtm} package


Exposures for Vaccine

Description

An example SDTM EX dataset for vaccine studies

Usage

ex_vaccine

Format

An object of class tbl_df (inherits from tbl, data.frame) with 4 rows and 21 columns.

Source

Constructed by {admiralvaccine} developers


Findings About Clinical Events for Vaccine

Description

An example SDTM FACE for vaccine studies

Usage

face_vaccine

Format

An object of class tbl_df (inherits from tbl, data.frame) with 307 rows and 30 columns.

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 GRPID be included in the output?

temp_env

Temporary environment


Immunogenicity Specimen Assessments for Vaccine

Description

An example SDTM IS for vaccine studies

Usage

is_vaccine

Format

An object of class tbl_df (inherits from tbl, data.frame) with 16 rows and 24 columns.

Source

Constructed by {admiralvaccine} developers


Laboratory Measurements

Description

An updated SDTM LB dataset that uses data from the CDISC pilot project

Usage

lb

Format

An object of class tbl_df (inherits from tbl, data.frame) with 59580 rows and 23 columns.

Author(s)

Annie Yang

Source

https://github.com/pharmaverse/pharmaversesdtm/blob/main/data/lb.rda


Medical History

Description

An updated SDTM MH dataset that uses data from the CDISC pilot project

Usage

mh

Format

An object of class tbl_df (inherits from tbl, data.frame) with 1818 rows and 28 columns.

Author(s)

Annie Yang

Source

https://github.com/cdisc-org/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/tabulations/sdtm/mh.xpt?raw=true # nolint


Ophthalmic Examinations for Ophthalmology

Description

A SDTM OE dataset simulated by Ophthalmology team

Usage

oe_ophtha

Format

An object of class grouped_df (inherits from tbl_df, tbl, data.frame) with 15344 rows and 25 columns.

Author(s)

Gordon Miller


Pharmacokinetic Concentrations

Description

A SDTM PC dataset simulated by Antonio Rodriguez Contesti

Usage

pc

Format

An object of class tbl_df (inherits from tbl, data.frame) with 4572 rows and 20 columns.

Author(s)

Antonio Rodriguez Contesti

Source

https://github.com/pharmaverse/pharmaversesdtm/blob/main/data/pc.rda


Pharmacokinetic Parameters

Description

A SDTM PP dataset simulated by Antonio Rodriguez Contesti

Usage

pp

Format

An object of class data.frame with 2688 rows and 14 columns.

Author(s)

Antonio Rodriguez Contesti

Source

https://github.com/pharmaverse/pharmaversesdtm/blob/main/data/pp.rda


Questionnaire for Ophthalmology

Description

An example Questionnaires SDTM dataset with ophthalmology-specific questionnaire of NEI VFQ-25

Usage

qs_ophtha

Format

An object of class tbl_df (inherits from tbl, data.frame) with 75922 rows and 20 columns.

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

An object of class tbl_df (inherits from tbl, data.frame) with 5808 rows and 19 columns.

Author(s)

Gopi Vegesna


Disease Response (IMWG)

Description

A SDTM RS dataset using IMWG criteria. The dataset contains just a few patients. It is intended for vignettes and examples of ADaM dataset creation.

Usage

rs_onco_imwg

Format

An object of class tbl_df (inherits from tbl, data.frame) with 65 rows and 17 columns.

Author(s)

Vinh Nguyen


Disease Response (iRECIST) for Oncology

Description

A SDTM RS dataset using iRECIST. The dataset contains just a few patients. It is intended for vignettes and examples of ADaM dataset creation.

Usage

rs_onco_irecist

Format

An object of class tbl_df (inherits from tbl, data.frame) with 376 rows and 19 columns.

Author(s)

Rohan Thampi


Disease Response (RECIST 1.1) for Oncology

Description

A SDTM RS dataset using RECIST 1.1. The dataset contains just a few patients. It is intended for vignettes and examples of ADaM dataset creation.

Usage

rs_onco_recist

Format

An object of class tbl_df (inherits from tbl, data.frame) with 66 rows and 14 columns.

Author(s)

Stefan Bundfuss

Source

The dataset is derived from tr_onco_recist.


Subject Characteristic for Ophthalmology

Description

A SDTM SC dataset simulated by Ophthalmology team

Usage

sc_ophtha

Format

An object of class tbl_df (inherits from tbl, data.frame) with 254 rows and 12 columns.

Author(s)

Gordon Miller


SDG

Description

An example SDG dataset

Usage

sdg_db

Format

An object of class tbl_df (inherits from tbl, data.frame) with 16 rows and 5 columns.


Standardized MedDRA Queries

Description

An example SMQ dataset

Usage

smq_db

Format

An object of class tbl_df (inherits from tbl, data.frame) with 44 rows and 6 columns.


Supplemental Adverse Events

Description

A SDTM SUPPAE dataset from the CDISC pilot project

Usage

suppae

Format

An object of class tbl_df (inherits from tbl, data.frame) with 1191 rows and 10 columns.

Source

https://github.com/cdisc-org/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/tabulations/sdtm/suppae.xpt?raw=true # nolint


Supplemental Qualifiers for Clinical Events for Vaccine

Description

An example SDTM SUPPCE for vaccine studies

Usage

suppce_vaccine

Format

An object of class tbl_df (inherits from tbl, data.frame) with 4 rows and 9 columns.

Source

Constructed by {admiralvaccine} developers


Supplemental Demography

Description

A SDTM SUPPDM dataset from the CDISC pilot project

Usage

suppdm

Format

An object of class tbl_df (inherits from tbl, data.frame) with 1197 rows and 10 columns.

Source

https://github.com/cdisc-org/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/tabulations/sdtm/suppdm.xpt?raw=true # nolint


Supplemental Qualifiers for Demographics for Vaccine

Description

An example SDTM SUPPDM dataset for vaccine studies

Usage

suppdm_vaccine

Format

An object of class tbl_df (inherits from tbl, data.frame) with 2 rows and 9 columns.

Source

Constructed by {admiralvaccine} developers


Supplemental Disposition

Description

A SDTM SUPPDS dataset from the CDISC pilot project

Usage

suppds

Format

An object of class tbl_df (inherits from tbl, data.frame) with 3 rows and 9 columns.

Source

https://github.com/cdisc-org/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/tabulations/sdtm/suppds.xpt?raw=true # nolint


Supplemental Qualifiers for Exposures for Vaccine

Description

An example SDTM SUPPEX dataset for vaccine studies

Usage

suppex_vaccine

Format

An object of class tbl_df (inherits from tbl, data.frame) with 4 rows and 9 columns.

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

An object of class tbl_df (inherits from tbl, data.frame) with 4 rows and 9 columns.

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

An object of class tbl_df (inherits from tbl, data.frame) with 16 rows and 10 columns.

Source

Constructed by {admiralvaccine} developers


Supplemental Qualifiers for RS_ONCO_IMWG

Description

A SDTM supplemental RS dataset using IMWG criteria. It is intended to be used together with rs_onco_imwg.

Usage

supprs_onco_imwg

Format

An object of class tbl_df (inherits from tbl, data.frame) with 19 rows and 9 columns.

Author(s)

Vinh Nguyen


Supplemental Tumor Results for Oncology

Description

A SDTM SUPPTR dataset simulated by Gopi Vegesna

Usage

supptr_onco

Format

An object of class tbl_df (inherits from tbl, data.frame) with 55995 rows and 9 columns.

Author(s)

Gopi Vegesna


Subject Visits

Description

A SDTM SV dataset from the CDISC pilot project. Duplicate observation for group variable USUBJID and VISIT is corrected.

Usage

sv

Format

An object of class tbl_df (inherits from tbl, data.frame) with 3559 rows and 8 columns.

Source

https://github.com/cdisc-org/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/tabulations/sdtm/sv.xpt?raw=true # nolint


Tumor Results for Oncology

Description

A SDTM TR dataset simulated by Gopi Vegesna

Usage

tr_onco

Format

An object of class tbl_df (inherits from tbl, data.frame) with 55995 rows and 24 columns.

Author(s)

Gopi Vegesna


Tumor Results (RECIST 1.1) for Oncology

Description

A SDTM TR dataset using RECIST 1.1. The dataset contains just a few patients. It is intended for vignettes and examples of ADaM dataset creation.

Usage

tr_onco_recist

Format

An object of class tbl_df (inherits from tbl, data.frame) with 546 rows and 19 columns.

Author(s)

Stefan Bundfuss


Trial Design

Description

A SDTM TS dataset from the CDISC pilot project

Usage

ts

Format

An object of class tbl_df (inherits from tbl, data.frame) with 33 rows and 6 columns.

Source

https://github.com/cdisc-org/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/tabulations/sdtm/ts.xpt?raw=true # nolint


Tumor Identification for Oncology

Description

A SDTM TU dataset simulated by Gopi Vegesna

Usage

tu_onco

Format

An object of class tbl_df (inherits from tbl, data.frame) with 7734 rows and 18 columns.

Author(s)

Gopi Vegesna


Tumor Identification (RECIST 1.1) for Oncology

Description

A SDTM TU dataset using RECIST 1.1. The dataset contains just a few patients. It is intended for vignettes and examples of ADaM dataset creation.

Usage

tu_onco_recist

Format

An object of class tbl_df (inherits from tbl, data.frame) with 75 rows and 16 columns.

Author(s)

Stefan Bundfuss


Vital Signs

Description

A SDTM VS dataset from the CDISC pilot project

Usage

vs

Format

An object of class tbl_df (inherits from tbl, data.frame) with 29643 rows and 24 columns.

Source

https://github.com/cdisc-org/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/tabulations/sdtm/vs.xpt?raw=true # nolint


Vital signs Dataset-pediatrics

Description

An updated SDTM VS dataset with anthropometric measurements for pediatric patients

Usage

vs_peds

Format

An object of class tbl_df (inherits from tbl, data.frame) with 164 rows and 26 columns.

Source

Constructed by {admiralpeds} developers


Vital Signs for Vaccine

Description

An example SDTM VS dataset for vaccine studies

Usage

vs_vaccine

Format

An object of class grouped_df (inherits from tbl_df, tbl, data.frame) with 28 rows and 23 columns.

Source

Constructed by {admiralvaccine} developers