Immunogenicity Specimen Assessments
Format
A data frame with 103 columns:
- STUDYID
Study Identifier
- USUBJID
Unique Subject Identifier
- SUBJID
Subject Identifier for the Study
- SITEID
Study Site Identifier
- COUNTRY
Country
- DOMAIN
Domain Abbreviation
- RFSTDTC
Subject Reference Start Date/Time
- RFENDTC
Subject Reference End Date/Time
- RFXSTDTC
Date/Time of First Study Treatment
- RFXENDTC
Date/Time of Last Study Treatment
- RFPENDTC
Date/Time of End of Participation
- DTHDTC
Date/Time of Death
- DTHFL
Subject Death Flag
- REGION1
Geographic Region 1
- BRTHDTC
Date/Time of Birth
- DMDTC
Date/Time of Collection
- DMDY
Study Day of Collection
- AGE
Age
- AGEU
Age Units
- AGEGR1
Pooled Age Group 1
- SEX
Sex
- RACE
Race
- RACEGR1
Pooled Race Group 1
- ETHNIC
Ethnicity
- SAFFL
Safety Population Flag
- PPROTFL
Per-Protocol Population Flag
- ARM
Description of Planned Arm
- ARMCD
Planned Arm Code
- ACTARM
Description of Actual Arm
- ACTARMCD
Actual Arm Code
- TRTP
Planned Treatment
- TRTA
Actual Treatment
- TRT01P
Planned Treatment for Period 01
- TRT01A
Actual Treatment for Period 01
- TRT02P
Planned Treatment for Period 02
- TRT02A
Actual Treatment for Period 02
- TRTSDT
Date of First Exposure to Treatment
- TRTSDTM
Datetime of First Exposure to Treatment
- TRTEDT
Date of Last Exposure to Treatment
- TRTEDTM
Datetime of Last Exposure to Treatment
- AP01SDT
Period 01 Start Date
- AP01EDT
Period 01 End Date
- AP02SDT
Period 02 Start Date
- AP02EDT
Period 02 End Date
- APERSDT
Period Start Date
- APEREDT
Period End Date
- RFICDTC
Date/Time of Informed Consent
- ADT
Analysis Date
- ADY
Analysis Relative Day
- AVISIT
Analysis Visit
- AVISITN
Analysis Visit (N)
- ATPT
Analysis Timepoint
- ATPTN
Analysis Timepoint (N)
- ATPTREF
Analysis Timepoint Reference
- APERIOD
Period
- PARAM
Parameter
- PARAMCD
Parameter Code
- PARAMN
Parameter (N)
- PARCAT1
Parameter Category 1
- AVAL
Analysis Value
- AVALU
Analysis Value Unit
- BASE
Baseline Value
- BASECAT1
Baseline Category 1
- BASETYPE
Baseline Type
- CHG
Change from Baseline
- R2BASE
Ratio to Baseline
- CRIT1
Analysis Criterion 1
- CRIT1FL
Criterion 1 Evaluation Result Flag
- CRIT1FN
Criterion 1 Evaluation Result Flag (N)
- DTYPE
Derivation Type
- ABLFL
Baseline Record Flag
- ISSEQ
Sequence Number
- ISTESTCD
Immunogenicity Test/Exam Short Name
- ISTEST
Immunogenicity Test or Examination Name
- 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
- ISMETHOD
Method of Test or Examination
- ISBLFL
Baseline Flag
- ISLLOQ
Lower Limit of Quantitation
- VISITNUM
Visit Number
- EPOCH
Epoch
- ISDTC
Date/Time of Collection
- ISDY
Study Day of Visit/Collection/Exam
- ISULOQ
Upper Limit of Quantitation
- LOD
Limit of Detection
- DERIVED
Derivation Method
- CUTOFF02
First Cutoff Value
- CUTOFF03
Second Cutoff Value
- SERCAT1
Pre-vaccination seropositivity status
- SERCAT1N
Pre-vaccination sero status (n)
- PPSRFL
Per-Protocol Record-Level Flag
- INVID
Investigator Identifier
- INVNAM
Investigator Name
- VAX01DT
Vaccination Date 01
- VAX02DT
Vaccination Date 02
Details
Contains a set of 16 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| I0019NLF | LOG10 4FOLD (I0019NT Antibody) |
| I0019NT | I0019NT Antibody |
| I0019NTF | 4FOLD (I0019NT Antibody) |
| I0019NTL | LOG10 (I0019NT Antibody) |
| J0033VLF | LOG10 4FOLD (J0033VN Antibody) |
| J0033VN | J0033VN Antibody |
| J0033VNF | 4FOLD (J0033VN Antibody) |
| J0033VNL | LOG10 (J0033VN Antibody) |
| M0019LLF | LOG10 4FOLD (M0019LN Antibody) |
| M0019LN | M0019LN Antibody |
| M0019LNF | 4FOLD (M0019LN Antibody) |
| M0019LNL | LOG10 (M0019LN Antibody) |
| R0003MA | R0003MA Antibody |
| R0003MAF | 4FOLD (R0003MA Antibody) |
| R0003MAL | LOG10 (R0003MA Antibody) |
| R0003MLF | LOG10 4FOLD (R0003MA Antibody) |
Examples
data("adis_vaccine")