Exposure Analysis

Usage

adex

Format

A data frame with 92 columns:

STUDYID: Study Identifier
DOMAIN: Domain Abbreviation
USUBJID: Unique Subject Identifier
EXSEQ: Sequence Number
EXTRT: Name of Treatment
EXDOSE: Dose
EXDOSU: Dose Units
EXDOSFRM: Dose Form
EXDOSFRQ: Dosing Frequency per Interval
EXROUTE: Route of Administration
VISITNUM: Visit Number
VISIT: Visit Name
VISITDY: Planned Study Day of Visit
EXSTDTC: Start Date/Time of Treatment
EXENDTC: End Date/Time of Treatment
EXSTDY: Study Day of Start of Treatment
EXENDY: Study Day of End of Treatment
EXADJ: Reason for Dose Adjustment
EXPLDOS: Planned Dose
TRTSDT: Date of First Exposure to Treatment
TRTSDTM: Datetime of First Exposure to Treatment
TRTEDTM: Datetime of Last Exposure to Treatment
ASTDTM: Analysis Start Datetime
ASTDTF: Analysis Start Date Imputation Flag
ASTTMF: Analysis Start Time Imputation Flag
AENDTM: Analysis End Datetime
AENDTF: Analysis End Date Imputation Flag
AENTMF: Analysis End Time Imputation Flag
ASTDY: Analysis Start Relative Day
AENDY: Analysis End Relative Day
EXDURD: Duration of Treatment (Days)
ASTDT: Analysis Start Date
AENDT: Analysis End Date
DOSEO: Dose O
PDOSEO: PDose O
PARAMCD: Parameter Code
AVAL: Analysis Value
AVALC: Analysis Value (C)
PARCAT1: Parameter Category 1
PARAM: Parameter
PARAMN: Parameter (N)
AVALCAT1: Analysis Value Category 1
ASEQ: Analysis Sequence Number
SUBJID: Subject Identifier for the Study
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
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
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
TRT01A: Actual Treatment for Period 01
TRTSTMF: Time of First Exposure Imput. Flag
TRTETMF: Time of Last Exposure Imput. Flag
TRTEDT: Date of Last Exposure to Treatment
TRTDURD: Total Treatment Duration (Days)
SCRFDT: Screen Failure Date
EOSDT: End of Study Date
EOSSTT: End of Study Status
FRVDT: Final Retrieval Visit Date
RANDDT: Date of Randomization
DTHDT: Date of Death
DTHDTF: Date of Death Imputation Flag
DTHADY: Relative Day of Death
LDDTHELD: Elapsed Days from Last Dose to Death
DTHCAUS: Cause of Death
DTHDOM: Domain for Date of Death Collection
DTHCGR1: Cause of Death Reason 1
LSTALVDT: Date Last Known Alive
SAFFL: Safety Population Flag
RACEGR1: Pooled Race Group 1
AGEGR1: Pooled Age Group 1
REGION1: Geographic Region 1
LDDTHGR1: Last Dose to Death - Days Elapsed Grp 1
DTH30FL: Death Within 30 Days of Last Trt Flag
DTHA30FL: Death After 30 Days from Last Trt Flag
DTHB30FL: Death Within 30 Days of First Trt Flag

Source

Generated from admiral package (template ad_adex.R).

Details

Contains a set of 19 unique Parameter Codes and Parameters:

PARAMCD	PARAM
ADJ	Dose adjusted during constant dosing interval
ADJAE	Dose adjusted due to AE during constant dosing interval
AVDDSE	Average daily dose administered (mg/mg)
DOSE	Dose administered during constant dosing interval (mg)
DURD	Study drug duration during constant dosing interval (days)
PADJ	Dose adjusted during W2-W24
PADJAE	Dose adjusted in W2-W24 due to AE
PAVDDSE	Average daily dose administered in W2-W24 (mg)
PDOSE	Total dose administered in W2-W2 (mg)4
PDOSINT	W2-24 dose intensity (%)
PDURD	Overall duration in W2-W24 (days)
PLDOSE	Planned dose during constant dosing interval (mg)
PPDOSE	Total planned dose in W2-W24 (mg)
TADJ	Dose adjusted during study
TADJAE	Dose adjusted during study due to AE
TDOSE	Total dose administered (mg)
TDOSINT	Overall dose intensity (%)
TDURD	Overall duration (days)
TPDOSE	Total planned dose (mg)

References

None

Examples

data("adex")