is_ada

A SDTM IS dataset containing relevant antidrug antibody assessment studies

dataset

Generic

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/>.

Lina Patil

pharmaversesdtm

SDTM Test Data for the 'Pharmaverse' Family of Packages

Stefan Bundfuss

Kristin Dahnert

Fanny Gautier

Edoardo Mancini

Tomoyuki Namai

Vinh Nguyen

Vladyslav Shuliar

Cytel Inc. 

F. Hoffmann-La Roche AG 

GlaxoSmithKline LLC 

is_ada function

A data frame with 27 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>ISSEQ</dt>
<dd>Sequence Number</dd><dt>ISTESTCD</dt>
<dd>Immunogenicity Test/Exam Short Name</dd><dt>ISTEST</dt>
<dd>Immunogenicity Test or Examination Name</dd><dt>ISBDAGNT</dt>
<dd>Binding Agent</dd><dt>ISCAT</dt>
<dd>Category for Immunogenicity Test</dd><dt>ISORRES</dt>
<dd>Results or Findings in Original Units</dd><dt>ISORRESU</dt>
<dd>Original Units</dd><dt>ISSTRESC</dt>
<dd>Character Result/Finding in Std Format</dd><dt>ISSTRESN</dt>
<dd>Numeric Results/Findings in Std. Units</dd><dt>ISSTRESU</dt>
<dd>Standard Units</dd><dt>ISSTAT</dt>
<dd>Completion Status</dd><dt>ISREASND</dt>
<dd>Reason Not Done</dd><dt>ISNAM</dt>
<dd>Vendor Name</dd><dt>ISSPEC</dt>
<dd>Specimen Type</dd><dt>ISBLFL</dt>
<dd>Baseline Flag</dd><dt>ISLLOQ</dt>
<dd>Lower Limit of Quantitation</dd><dt>VISITNUM</dt>
<dd>Visit Number</dd><dt>VISIT</dt>
<dd>Visit Name</dd><dt>VISITDY</dt>
<dd>Planned Study Day of Visit</dd><dt>EPOCH</dt>
<dd>Epoch</dd><dt>ISDTC</dt>
<dd>Date/Time of Collection</dd><dt>ISDY</dt>
<dd>Study Day of Visit/Collection/Exam</dd><dt>ISTPT</dt>
<dd>Planned Time Point Name</dd><dt>ISTPTNUM</dt>
<dd>Planned Time Point Number</dd>
</dl>

Format

Author

Immunogenicity Specimen Assessments for ADA — is_ada

A data frame with 27 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>ISSEQ</dt>
<dd>Sequence Number</dd>

<dt>ISTESTCD</dt>
<dd>Immunogenicity Test/Exam Short Name</dd>

<dt>ISTEST</dt>
<dd>Immunogenicity Test or Examination Name</dd>

<dt>ISBDAGNT</dt>
<dd>Binding Agent</dd>

<dt>ISCAT</dt>
<dd>Category for Immunogenicity Test</dd>

<dt>ISORRES</dt>
<dd>Results or Findings in Original Units</dd>

<dt>ISORRESU</dt>
<dd>Original Units</dd>

<dt>ISSTRESC</dt>
<dd>Character Result/Finding in Std Format</dd>

<dt>ISSTRESN</dt>
<dd>Numeric Results/Findings in Std. Units</dd>

<dt>ISSTRESU</dt>
<dd>Standard Units</dd>

<dt>ISSTAT</dt>
<dd>Completion Status</dd>

<dt>ISREASND</dt>
<dd>Reason Not Done</dd>

<dt>ISNAM</dt>
<dd>Vendor Name</dd>

<dt>ISSPEC</dt>
<dd>Specimen Type</dd>

<dt>ISBLFL</dt>
<dd>Baseline Flag</dd>

<dt>ISLLOQ</dt>
<dd>Lower Limit of Quantitation</dd>

<dt>VISITNUM</dt>
<dd>Visit Number</dd>

<dt>VISIT</dt>
<dd>Visit Name</dd>

<dt>VISITDY</dt>
<dd>Planned Study Day of Visit</dd>

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

<dt>ISDTC</dt>
<dd>Date/Time of Collection</dd>

<dt>ISDY</dt>
<dd>Study Day of Visit/Collection/Exam</dd>

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

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


</dl>

Immunogenicity Specimen Assessments for ADA

ISTESTCD	ISTEST
ADA_BAB	Binding Antidrug Antibody
ADA_NAB	Neutralizing Binding Antidrug Antibody

is_ada: Immunogenicity Specimen Assessments for ADA

Description

Usage

Arguments

Format

Author

Details