ce_vaccine

An example SDTM CE dataset for vaccine studies

dataset

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 the CDISC SDTM implementation guide, accessible by
creating a free account on <https://www.cdisc.org/>.

Edoardo Mancini

pharmaversesdtm

SDTM Test Data for the 'Pharmaverse' Family of Packages

Fanny Gautier

Gayatri G

Kangjie Zhang

Lina Patil

Pooja Kumari

Sadchla Mascary

Stefan Bundfuss

Tomoyuki Namai

Vinh Nguyen

Vladyslav Shuliar

Zelos Zhu

ce_vaccine function

A data frame with 29 columns:<dl>
<dt>STUDYID</dt>
<dd>Study Identifier</dd><dt>DOMAIN</dt>
<dd>Domain Abbreviation</dd><dt>USUBJID</dt>
<dd>Unique Subject Identifier</dd><dt>CESEQ</dt>
<dd>Sequence Number</dd><dt>CELNKID</dt>
<dd>Link ID</dd><dt>CELNKGRP</dt>
<dd>Link Group ID</dd><dt>CETERM</dt>
<dd>Reported Term for the Clinical Event</dd><dt>CEDECOD</dt>
<dd>Dictionary-Derived Term</dd><dt>CELAT</dt>
<dd>Laterality of Location of Clinical Event</dd><dt>CELOC</dt>
<dd>Location of Clinical Event</dd><dt>CECAT</dt>
<dd>Category for Clinical Event</dd><dt>CESCAT</dt>
<dd>Subcategory for Clinical Event</dd><dt>CEPRESP</dt>
<dd>Clinical Event Pre-Specified</dd><dt>CEOCCUR</dt>
<dd>Clinical Event Occurrence</dd><dt>CESEV</dt>
<dd>Severity/Intensity</dd><dt>CEREL</dt>
<dd>Causality</dd><dt>CEOUT</dt>
<dd>Outcome of Clinical Event</dd><dt>EPOCH</dt>
<dd>Epoch</dd><dt>CEDTC</dt>
<dd>Date/Time of Event Collection</dd><dt>CESTDTC</dt>
<dd>Start Date/Time of Clinical Event</dd><dt>CEENDTC</dt>
<dd>End Date/Time of Clinical Event</dd><dt>CEDUR</dt>
<dd>Duration of Clinical Event</dd><dt>CETPT</dt>
<dd>Planned Time Point Name</dd><dt>CETPTNUM</dt>
<dd>Planned Time Point Number</dd><dt>CETPTREF</dt>
<dd>Time Point Reference</dd><dt>CERFTDTC</dt>
<dd>Date/Time of Reference Time Point</dd><dt>CEEVINTX</dt>
<dd>Evaluation Interval Text</dd><dt>CESTAT</dt>
<dd>Completion Status</dd><dt>CEREASND</dt>
<dd>Reason Clinical Event Not Collected</dd>
</dl>

Format

Clinical Events for Vaccine — ce_vaccine

A data frame with 29 columns:<dl>
<dt>STUDYID</dt>
<dd>Study Identifier</dd>

<dt>DOMAIN</dt>
<dd>Domain Abbreviation</dd>

<dt>USUBJID</dt>
<dd>Unique Subject Identifier</dd>

<dt>CESEQ</dt>
<dd>Sequence Number</dd>

<dt>CELNKID</dt>
<dd>Link ID</dd>

<dt>CELNKGRP</dt>
<dd>Link Group ID</dd>

<dt>CETERM</dt>
<dd>Reported Term for the Clinical Event</dd>

<dt>CEDECOD</dt>
<dd>Dictionary-Derived Term</dd>

<dt>CELAT</dt>
<dd>Laterality of Location of Clinical Event</dd>

<dt>CELOC</dt>
<dd>Location of Clinical Event</dd>

<dt>CECAT</dt>
<dd>Category for Clinical Event</dd>

<dt>CESCAT</dt>
<dd>Subcategory for Clinical Event</dd>

<dt>CEPRESP</dt>
<dd>Clinical Event Pre-Specified</dd>

<dt>CEOCCUR</dt>
<dd>Clinical Event Occurrence</dd>

<dt>CESEV</dt>
<dd>Severity/Intensity</dd>

<dt>CEREL</dt>
<dd>Causality</dd>

<dt>CEOUT</dt>
<dd>Outcome of Clinical Event</dd>

<dt>EPOCH</dt>
<dd>Epoch</dd>

<dt>CEDTC</dt>
<dd>Date/Time of Event Collection</dd>

<dt>CESTDTC</dt>
<dd>Start Date/Time of Clinical Event</dd>

<dt>CEENDTC</dt>
<dd>End Date/Time of Clinical Event</dd>

<dt>CEDUR</dt>
<dd>Duration of Clinical Event</dd>

<dt>CETPT</dt>
<dd>Planned Time Point Name</dd>

<dt>CETPTNUM</dt>
<dd>Planned Time Point Number</dd>

<dt>CETPTREF</dt>
<dd>Time Point Reference</dd>

<dt>CERFTDTC</dt>
<dd>Date/Time of Reference Time Point</dd>

<dt>CEEVINTX</dt>
<dd>Evaluation Interval Text</dd>

<dt>CESTAT</dt>
<dd>Completion Status</dd>

<dt>CEREASND</dt>
<dd>Reason Clinical Event Not Collected</dd>


</dl>

Clinical Events for Vaccine

ce_vaccine: Clinical Events for Vaccine

Description

Usage

Arguments

Format

Details