...
The ADSL contains subject characteristics and covariates that are important for analyses. Stratification variables can be created in the ADSL to subset the data. More than one SDTM dataset may be used as input to the ADSL. This is a simplified example ADSL dataset; the ADaMIG should be referenced for additional variables.
For this example:
- Analysis age (AAGE) was included to provide age with more precision.
- A flag indicating the use of ACE inhibitors (ACEINHFL) was derived from the CM dataset.
- Body surface area at screening (BSASC) was derived from the VS dataset using height and weight at the screening visit. There are many possible calculations for BSA; for this example, the Du Bois method was used (ref: https://www.calculator.net/body-surface-area-calculator.html). Note that the screening visit and visit 1 occurred at the same time in this example.Analysis age (AAGE) was included to provide age with more precision.
| Definexmltable |
|---|
| Dataset | ADSL |
|---|
| Level | Variable |
|---|
| Purpose | Analysis |
|---|
| Name | Variable |
|---|
|
| Variable Name | Variable Label | Type | Codelist/Controlled Terms/Format | Source | Derivation/Comment |
|---|
| STUDYID | Study Identifier | Char |
| DM.STUDYID |
| | USUBJID | Unique Subject Identifier | Char |
| |
| | BRTHDT | Date of Birth | Num | date9. |
| Date portion of DM.BRTHDTC converted to numeric and displayed in a format such as date9.from ISO 8601 format to numeric date.9 | | AAGE | Analysis Age | Num |
|
| Age as screening, computed by DM.RFICDTC - BRTHDTC as continuous variable. Note that some countries do not allow capturing date of birth, so this could be computed by capturing age in years and months on a CRF. | | AGE | Age | Num |
| DM.AGE |
| | AGEU | Age Units | Char | YEARS | DM.AGEU |
| SEX | Sex | Char | (SEX) | DM.SEX |
| RACE | Race | Num | (RACE) | DM.RACE |
| | TRTSDT | Date of First Exposure to Treatment | Num | date9. |
| Date portion of DM.RFSTDTC converted to numeric and displayed in a format such as date9. | | RFICDT | | Num | date9. |
| Date portion of DM.RFICDTC converted to numeric and displayed in a format such as date9. | | DTHDT | | Num | date9. |
| Date portion of DM.RFSTDTC converted to numeric and displayed in a format such as date9. | | DTHFL | | Char | Y | DM.DTHFL |
| | TRT01P | Planned Treatment for Period 01 | Char | Drug A, Drug B |
| Predecessor: DM.ARM. May be changed to lower case or more descriptive term for use in tables and listings. | | TRT01A | Actual Treatment for Period 01 | Char | Drug A, Drug B |
| Predecessor: DM.ACTARM. Note: Actual treatment matches planned treatment unless there is a reason subject does not take planned drug. | ITTFL | Intent-To-Treat Population Flag | Char | Y; N |
| Derive the intent-to-treat population as per the protocol and SAP. | ACEINHFL | ACE Inhibitor Medications Flag | Char | Y; N |
| Select a list of ACE inhibitor medications from concomitant medications (CM) domain as per Statistical Analysis Plan or Protocol. Set to "Y" if these medications were taken during the study, and "N" if they are absent. Can be used to subset or to exclude the population who took ACE inhibitors. | HEIGHTSC | Height (cm) at Screening | Num |
|
| Set to VS.VSSTRESN where VS.VSTESTCD = "HEIGHT" and VISITNUM= 1 (or screening visit for your study). | WEIGHTSC | Weight (kg) at Screening | Num |
|
| Set to VS.VSSTRESN where VS.VSTESTCD = "WEIGHT" and VISITNUM = 1 (or screening visit for your study). | BSASC | Body Surface Area at Screening | Num |
|
| Select where VISITNUM = 1 (or screening visit for your study). Compute from HEIGHT and WEIGHT, using the Du Bois method. BSA = 0.007184 × W0.425 × H0.725 There are multiple methods and the study protocol should describe which one to use (e.g., Du Bois, Mosteller, Haycock, Gehan & George, Boyd, Fujimoto, Takahira, and Schlich). |
|
...