Exposure Analysis
adexA data frame with 92 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country
Domain Abbreviation
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of End of Participation
Screen Failure Date
Final Retrieval Visit Date
Date/Time of Death
Relative Day of Death
Subject Death Flag
Elapsed Days from Last Dose to Death
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Domain for Date of Death Collection
Death Within 30 Days of First Trt Flag
Analysis Sequence Number
Geographic Region 1
Date/Time of Collection
Study Day of Collection
Age
Age Units
Pooled Age Group 1
Sex
Race
Pooled Race Group 1
Ethnicity
Safety Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
End of Study Status
End of Study Date
Date/Time of Informed Consent
Date of Randomization
Date Last Known Alive
Total Treatment Duration (Days)
Date of Death
Date of Death Imputation Flag
Cause of Death
Cause of Death Reason 1
Name of Treatment
Dose
Dose Form
Dosing Frequency per Interval
Route of Administration
Reason for Dose Adjustment
Start Date/Time of Treatment
End Date/Time of Treatment
Study Day of Start of Treatment
Study Day of End of Treatment
Sequence Number
Analysis Start Date
Analysis End Date
Duration of Treatment (Days)
Dose Units
Visit Number
Visit Name
Planned Study Day of Visit
Planned Dose
Analysis Start Datetime
Analysis Start Date Imputation Flag
Analysis Start Time Imputation Flag
Analysis End Datetime
Analysis End Date Imputation Flag
Analysis End Time Imputation Flag
Analysis Start Relative Day
Analysis End Relative Day
Dose O
PDose O
Parameter Code
Analysis Value
Analysis Value (C)
Parameter Category 1
Parameter
Parameter (N)
Analysis Value Category 1
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) |
None