A SDTM IS dataset containing relevant antidrug antibody assessment studies
Format
A data frame with 27 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- ISSEQ
Sequence Number
- ISTESTCD
Immunogenicity Test/Exam Short Name
- ISTEST
Immunogenicity Test or Examination Name
- ISBDAGNT
Binding Agent
- ISCAT
Category for Immunogenicity Test
- ISORRES
Results or Findings in Original Units
- ISORRESU
Original Units
- ISSTRESC
Character Result/Finding in Std Format
- ISSTRESN
Numeric Results/Findings in Std. Units
- ISSTRESU
Standard Units
- ISSTAT
Completion Status
- ISREASND
Reason Not Done
- ISNAM
Vendor Name
- ISSPEC
Specimen Type
- ISBLFL
Baseline Flag
- ISLLOQ
Lower Limit of Quantitation
- VISITNUM
Visit Number
- VISIT
Visit Name
- VISITDY
Planned Study Day of Visit
- EPOCH
Epoch
- ISDTC
Date/Time of Collection
- ISDY
Study Day of Visit/Collection/Exam
- ISTPT
Planned Time Point Name
- ISTPTNUM
Planned Time Point Number