Anti-Drug Antibody Analysis Dataset
Format
A data frame with 72 columns:
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- SUBJID
Subject Identifier for the Study
- SITEID
Study Site Identifier
- ASEQ
Analysis Sequence Number
- REGION1
Geographic Region 1
- COUNTRY
Country
- ETHNIC
Ethnicity
- AGE
Age
- AGEU
Age Units
- SEX
Sex
- RACE
Race
- SAFFL
Safety Population Flag
- TRT01P
Description of Planned Arm
- TRT01A
Description of Actual Arm
- TRTSDTM
Datetime of First Exposure to Treatment
- TRTSDT
Date of First Exposure to Treatment
- TRTEDTM
Datetime of Last Exposure to Treatment
- TRTEDT
Date of Last Exposure to Treatment
- ISSEQ
Sequence Number
- ISTESTCD
Immunogenicity Test/Exam Short Name
- ISTEST
Immunogenicity Test or Examination Name
- ISCAT
Category for Immunogenicity Test
- ISBDAGNT
Binding Agent
- ISSTRESC
Character Result/Finding in Std Format
- ISSTRESN
Numeric Results/Findings in Std. Units
- ISSTRESU
Standard Units
- ISSTAT
Completion Status
- ISREASND
Reason Not Done
- ISSPEC
Specimen Type
- DTL
Drug Tolerance Level
- MRT
Minimum Reportable Titer
- 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
- PARAM
Parameter
- PARAMCD
Parameter Code
- PARCAT1
Parameter Category 1
- AVAL
Analysis Value
- AVALC
Analysis Value (C)
- AVALU
Analysis Value Unit
- BASETYPE
Baseline Type
- BASE
Baseline Value
- CHG
Change from Baseline
- DTYPE
Derivation Type
- ADTM
Analysis Datetime
- ADT
Analysis Date
- ADY
Analysis Relative Day
- ATMF
Analysis Time Imputation Flag
- AVISIT
Analysis Visit
- AVISITN
Analysis Visit (N)
- ATPT
Analysis Timepoint
- APHASE
Phase
- APHASEN
Phase (N)
- APERIOD
Period
- APERIODC
Period (C)
- FANLDTM
First Datetime of Dose for Analyte
- FANLDT
First Date of Dose for Analyte
- FANLTM
First Time of Dose for Analyte
- FANLTMF
First Time of Dose for Analyte ImputeFL
- NFRLT
Nom. Rel. Time from Analyte First Dose
- AFRLT
Act. Rel. Time from Analyte First Dose
- FRLTU
Rel. Time from First Dose Unit
- ABLFL
Baseline Record Flag
- ADABLPFL
Baseline ADA Eval. Param-Level Flag
- ADPBLPFL
Post-Baseline ADA Eval. Param-Level Flag
- ADAFL
ADA Population Flag
Details
Contains a set of 22 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| ADADUR1 | ADA Duration (Weeks), Anti-XANOMELINE Antibody (1) |
| ADASTAT1 | ADA Status of a patient, Anti-XANOMELINE Antibody (1) |
| ADASTTV1 | ADA Status of a patient by Visit, Anti-XANOMELINE Antibody (1) |
| BABXANOM | Anti-XANOMELINE Antibody, Titer Units (1) |
| BFLAG1 | Baseline Pos/Neg, Anti-XANOMELINE Antibody (1) |
| EMERNEG1 | Treatment Emergent - Negative, Anti-XANOMELINE Antibody (1) |
| EMERPOS1 | Treatment Emergent - Positive, Anti-XANOMELINE Antibody (1) |
| ENHANC1 | Treatment enhanced ADA, Anti-XANOMELINE Antibody (1) |
| FPPDTM1 | First Post Dose Positive Datetime, Anti-XANOMELINE Antibody (1) |
| INDUCD1 | Treatment induced ADA, Anti-XANOMELINE Antibody (1) |
| LPPDTM1 | Last Post Dose Positive Datetime, Anti-XANOMELINE Antibody (1) |
| NABSTAT1 | Nab Status, Anti-XANOMELINE Neutralizing Antibody (1) |
| NABXANOM | Anti-XANOMELINE Neutralizing Antibody (1) |
| NOTRREL1 | No treatment related ADA, Anti-XANOMELINE Antibody (1) |
| PBFLAGV1 | Post Baseline Pos/Neg by Visit, Anti-XANOMELINE Antibody (1) |
| PERSADA1 | Persistent ADA, Anti-XANOMELINE Antibody (1) |
| RESULT1 | ADA interpreted per sample result, Anti-XANOMELINE Antibody (1) |
| RESULT2 | Nab interpreted per sample result, Anti-XANOMELINE Neutralizing Antibody (2) |
| TFLAGV1 | Treatment related ADA by Visit, Anti-XANOMELINE Antibody (1) |
| TIMADA1 | Time to onset of ADA (Weeks), Anti-XANOMELINE Antibody (1) |
| TRANADA1 | Transient ADA, Anti-XANOMELINE Antibody (1) |
| TRUNAFF1 | Treatment unaffected, Anti-XANOMELINE Antibody (1) |
Examples
data("adab")