adis_vaccine {pharmaverseadam}

Immunogenicity Specimen Assessments

Description

An example of ADIS dataset for Vaccine studies

Usage

adis_vaccine

Format

A data frame with 102 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

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

AVISITN

Analysis Visit (N)

AVISIT

Analysis Visit

ATPTN

Analysis Timepoint (N)

ATPT

Analysis Timepoint

ATPTREF

Analysis Timepoint Reference

ADT

Analysis Date

RFSTDTC

Subject Reference Start Date/Time

PPROTFL

Per-Protocol Population Flag

ADY

Analysis Relative Day

PARAMCD

Parameter Code

PARAM

Parameter

PARAMN

Parameter (N)

PARCAT1

Parameter Category 1

CUTOFF02

First Cutoff Value

CUTOFF03

Second Cutoff Value

AVAL

Analysis Value

AVALU

Analysis Value Unit

SERCAT1

Pre-vaccination seropositivity status

SERCAT1N

Pre-vaccination sero status (n)

DTYPE

Derivation Type

BASETYPE

Baseline Type

BASE

Baseline Value

ABLFL

Baseline Record Flag

BASECAT1

Baseline Category 1

CHG

Change from Baseline

R2BASE

Ratio to Baseline

CRIT1FL

Criterion 1 Evaluation Result Flag

CRIT1FN

Criterion 1 Evaluation Result Flag (N)

CRIT1

Analysis Criterion 1

APERIOD

Period

APERSDT

Period Start Date

APEREDT

Period End Date

TRTA

Actual Treatment

TRTP

Planned Treatment

PPSRFL

Per-Protocol Record-Level Flag

SUBJID

Subject Identifier for the Study

RFENDTC

Subject Reference End Date/Time

RFXSTDTC

Date/Time of First Study Treatment

RFXENDTC

Date/Time of Last Study Treatment

RFICDTC

Date/Time of Informed Consent

RFPENDTC

Date/Time of End of Participation

DTHDTC

Date/Time of Death

DTHFL

Subject Death Flag

SITEID

Study Site Identifier

INVID

Investigator Identifier

INVNAM

Investigator Name

BRTHDTC

Date/Time of Birth

AGE

Age

AGEU

Age Units

SEX

Sex

RACE

Race

ETHNIC

Ethnicity

ARMCD

Planned Arm Code

ARM

Description of Planned Arm

ACTARMCD

Actual Arm Code

ACTARM

Description of Actual Arm

COUNTRY

Country

DMDTC

Date/Time of Collection

DMDY

Study Day of Collection

TRT01P

Planned Treatment for Period 01

TRT02P

Planned Treatment for Period 02

TRT01A

Actual Treatment for Period 01

TRT02A

Actual Treatment for Period 02

TRTSDTM

Datetime of First Exposure to Treatment

TRTEDTM

Datetime of Last Exposure to Treatment

TRTSDT

Date of First Exposure to Treatment

TRTEDT

Date of Last Exposure to Treatment

SAFFL

Safety Population Flag

RACEGR1

Pooled Race Group 1

AGEGR1

Pooled Age Group 1

REGION1

Geographic Region 1

VAX01DT

Vaccination Date 01

VAX02DT

Vaccination Date 02

AP01SDT

Period 01 Start Date

AP01EDT

Period 01 End Date

AP02SDT

Period 02 Start Date

AP02EDT

Period 02 End Date

Source

Generated from admiralvaccine package (template ad_adis.R).

References

None

Examples

data("adis_vaccine")