Findings About Clinical Events Analysis

Source: R/adface_vaccine.R

Findings About Clinical Events Analysis

adface_vaccine

Format

A data frame with 61 columns:

STUDYID

Study Identifier

USUBJID

Unique Subject Identifier

SUBJID

Subject Identifier for the Study

SITEID

Study Site Identifier

AGE

Age

AGEU

Age Units

SEX

Sex

RACE

Race

SAFFL

Safety Population Flag

ARM

Description of Planned Arm

ARMCD

Planned Arm Code

ACTARM

Description of Actual Arm

ACTARMCD

Actual Arm Code

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

FATEST

Findings About Test Name

FALNKID

Link ID

FALNKGRP

Link Group ID

FATESTCD

Findings About Test Short Name

PARAMCD

Parameter Code

PARAM

Parameter

PARAMN

Parameter (N)

FAOBJ

Object of the Observation

PARCAT1

Parameter Category 1

PARCAT2

Parameter Category 2

AVALC

Analysis Value (C)

AVAL

Analysis Value

FASTAT

Completion Status

FAREASND

Reason Not Performed

FAEVAL

Evaluator

EPOCH

Epoch

ADT

Analysis Date

ADTM

Analysis Datetime

FAEVINTX

Evaluation Interval Text

ADY

Analysis Relative Day

ATPT

Analysis Timepoint

ATPTN

Analysis Timepoint (N)

ATPTREF

Analysis Timepoint Reference

EXDOSE

Dose

EXTRT

Name of Treatment

EXSTDTC

Start Date/Time of Treatment

EXENDTC

End Date/Time of Treatment

TRTA

Actual Treatment

TRTP

Planned Treatment

APERIOD

Period

APERSDT

Period Start Date

APEREDT

Period End Date

FAORRES

Result or Finding in Original Units

TRT01P

Planned Treatment for Period 01

TRT02P

Planned Treatment for Period 02

TRT01A

Actual Treatment for Period 01

TRT02A

Actual Treatment for Period 02

VAX01DT

Vaccination Date 01

VAX02DT

Vaccination Date 02

EVENTFL

Event Value Flag

EVENTDFL

Day Event Value Flag

ANL01FL

Analysis Flag 01

ANL02FL

Analysis Flag 02

ANL03FL

Analysis Flag 03

Source

Generated from admiralvaccine package (template ad_adface.R).

Details

Contains a set of 30 unique Parameter Codes and Parameters:

PARAMCDPARAM
DIARERedness diameter deltoid muscle left
DIASWELSwelling diameter deltoid muscle left
MAXREDNRedness maximum severity deltoid muscle left
MAXSFATFatigue maximum severity
MAXSHEAHeadache maximum severity
MAXSPISPain at injection site maximum severity deltoid muscle left
MAXSWELSwelling maximum severity deltoid muscle left
MAXTEMPFever maximum temperature
MDIRERedness maximum diameter deltoid muscle left
MDISWSwelling maximum diameter deltoid muscle left
MSEVNWJPNew or worsened joint pain maximum severity
MSEVNWMPNew or worsened muscle pain maximum severity
OCCHILLSChills occurrence indicator
OCCNWJPNew or worsened joint pain occurrence indicator
OCCNWMPNew or worsened muscle pain occurrence indicator
OCCVOMVomiting occurrence indicator
OCDIARDiarrhea occurrence indicator
OCFATIGFatigue occurrence indicator
OCFEVERFever occurrence indicator
OCHEADHeadache occurrence indicator
OCINSSwelling occurrence indicator deltoid muscle left
OCISRRedness occurrence indicator deltoid muscle left
OCPISPain at injection site occurrence indicator deltoid muscle left
SEVFATFatigue severity/intensity
SEVHEADHeadache severity/intensity
SEVNWJPNew or worsened joint pain severity/intensity
SEVNWMPNew or worsened muscle pain severity/intensity
SEVPISPain at injection site severity/intensity deltoid muscle left
SEVREDNRedness severity/intensity deltoid muscle left
SEVSWELSwelling severity/intensity deltoid muscle left

References

None

Examples

data("adface_vaccine")