Anti-Drug Antibody Analysis Dataset
adabA data frame with 72 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Analysis Sequence Number
Geographic Region 1
Country
Ethnicity
Age
Age Units
Sex
Race
Safety Population Flag
Description of Planned Arm
Description of Actual Arm
Datetime of First Exposure to Treatment
Date of First Exposure to Treatment
Datetime of Last Exposure to Treatment
Date of Last Exposure to Treatment
Sequence Number
Immunogenicity Test/Exam Short Name
Immunogenicity Test or Examination Name
Category for Immunogenicity Test
Binding Agent
Character Result/Finding in Std Format
Numeric Results/Findings in Std. Units
Standard Units
Completion Status
Reason Not Done
Specimen Type
Drug Tolerance Level
Minimum Reportable Titer
Visit Number
Visit Name
Planned Study Day of Visit
Epoch
Date/Time of Collection
Study Day of Visit/Collection/Exam
Planned Time Point Name
Planned Time Point Number
Parameter
Parameter Code
Parameter Category 1
Analysis Value
Analysis Value (C)
Analysis Value Unit
Baseline Type
Baseline Value
Change from Baseline
Derivation Type
Analysis Datetime
Analysis Date
Analysis Relative Day
Analysis Time Imputation Flag
Analysis Visit
Analysis Visit (N)
Analysis Timepoint
Phase
Phase (N)
Period
Period (C)
First Datetime of Dose for Analyte
First Date of Dose for Analyte
First Time of Dose for Analyte
First Time of Dose for Analyte ImputeFL
Nom. Rel. Time from Analyte First Dose
Act. Rel. Time from Analyte First Dose
Rel. Time from First Dose Unit
Baseline Record Flag
Baseline ADA Eval. Param-Level Flag
Post-Baseline ADA Eval. Param-Level Flag
ADA Population Flag
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) |
None