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The SDTM examples used as the source data are from Section 2.1, Basic Systolic Function. The ADSL draws from the DM dataset, which shows 4 subjects. The CV dataset shows two visits for the first subject , DMD-EF-01-101. It contains 16 rows, 1-8 for visit 1 and 9-16 for visit 6. Of these rows, the The records for which CVTESTCD = "LVEF_C" and CVTESTCD = "RVEF_C" representing the Ventricular Ejection Fraction, Calculated (%) for left and right were selected for the analysis. The records in the LB dataset test where LBTESTCD = "BNPPRONT" was used to add the value of BNPPRONT were used to compute the percent change over time , and then was added as a potential covariate in each row for the last analysis.
Example Analysis Datasets
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| Definexmltable |
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| Dataset | ADSL |
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| Level | Variable |
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| Purpose | Analysis |
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| Name | Variable |
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|
| 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 |
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| Set to VS.VSSTRESN where VS.VSTESTCD = "HEIGHT" and VISITNUM= 1 (or screening visit for your study). | WEIGHTSC | Weight (kg) at Screening | Num |
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| Set to VS.VSSTRESN where VS.VSTESTCD = "WEIGHT" and VISITNUM = 1 (or screening visit for your study). | BSASC | Body Surface Area at Screening | Num |
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| 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 Note that there 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). |
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| Definexmltable |
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| Dataset | ADCVNTP |
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| Level | Variable |
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| Purpose | Analysis |
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| Name | Variable |
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| Variable Name | Variable Label | Type | Codelist/Controlled Terms/Format | Source | Derivation/Comment |
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| STUDYID | Study Identifier | Char |
| CV.STUDYID |
| | USUBJID | Unique Subject Identifier | Char |
| |
| | BRTHDT | Date of Birth | Num | Date9. | ADSL.BRTHDT |
| | AGE | Age | Num |
| ADSL.AAGE |
| | AGEU | Age Unit | Char | YEARS | ADSL.AGEU |
| SEX | Sex | Char | (SEX) | DM.SEX |
| RACE | Race | Num | (RACE) | DM.RACE |
| | TRTSDT | Date of First Exposure to Treatment | Num | date9 | ADSL.TRTSDT |
| | TRT01P | Planned Treatment for Period 01 | Char | Drug A; Drug B | ADSL.TRT01P |
| | TRT01A | Actual Treatment for Period 01 | Char | Drug A; Drug B | ADSL.TRT01A |
| ITTFL | Intent-To-Treat Population Flag | Char | Y; N | ADSL.ITTFL | | | BSASC | Body Surface Area at Screening | Num |
| ADSL.BSASC | | HEIGHT | Height (cm) | Num |
|
| Set to VS.VSSTRESN where VS.VSTEST = "HEIGHT" by visit. | WEIGHT | Weight (kg) | Num |
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| Set to VS.VSSTRESN where VS.VSTEST = "WEIGHT" by visit. | | BSA | Body Surface Area (m2) | Num |
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| Compute from HEIGHT and WEIGHT at each visit, using the Du Bois method. BSA = 0.007184 × W0.425 × H0.725 Note that there There are multiple methods and the study protocol should describe which one to use (e.g., Mosteller, Haycock, Gehan & George, Boyd, Fujimoto, Takahira, and Schlich). | ACEINHFL | ACE Inhibitor Medications Flag | Char | Y; N | ADSL.ACEINHFL |
| | PARAM | Parameter | Char | Left Ventricular Ejection Fraction, Calculated (%); Right Ventricular Ejection Fraction, Calculated (%); N-Terminal ProB-type Natriuretic Peptide (pg/mL) | For tests from CV , set to the values of CV.CVTEST plus CV.CVTESTU with spaces and parentheses as shown. For tests from LB , set to the value of LB.LBTEST plus LB.LBTESTU with spaces and parentheses as shown. |
| | PARAMCD | Parameter Code | Char | LVEF_C; RVEF_C; BNPPRONT | CV.CVTESTCD LB.LBTESTCDNote: for this example dataset, select the records where the test values shown at left are included. |
| | PARAMN | Parameter (N) | Num |
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| Number PARAMCD as follows: LVEF_C = "1" RVEF_C = "2" BNPPRONT = "3" | | AVAL | Analysis Value | Num |
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| See Parameter Value Metadata | | AVISIT | Analysis Visit | Char | Visit 1 (Baseline); Visit 6 (1 Year) |
| If CV.VISIT = "VISIT 1" then AVISIT = "Visit 1 (Baseline)". If CV.VISIT = "VISIT 6" then AVISIT = "Visit 6 (1 Year)". | | AVISITN | Analysis Visit (N) | Num | 1; 6 | CV.VISITNUM LB.VISITNUM |
| | VISIT | Visit | Num | VISIT 1; VISIT 6 | CV.VISIT LB.VISIT |
| | ADT | Analysis Date | Num | date9. |
| Date portion of CV.CVDTC or LB.LBDTC converted to numeric and displayed in a format such as date9. | | ABLFL | Baseline Record Flag | Char | Y |
| If CV.VISIT = "VISIT 1" then ABLFL = "Y". | | BASE | Baseline Value | Num |
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| Set BASE to AVAL from the record for that subject and parameter where ABLFL = "Y". Populate BASE for additional visits by merging the value of BASE in the baseline record by USUBJID and PARAMCD. | | CHG | Change from Baseline | Num |
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| Compute CHG = AVAL - BASE for that record. Only compute for post-baseline records. | | PCHG | Percent Change from Baseline | Num |
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| Compute PCHG = (CHG / BASE) * 100. Only compute for post-baseline records. | | CHGCAT1 | Change from Baseline Category 1 | Char | Decline >=5% ; Decline <5% Increase GT 100 pg/mL |
| See Parameter Value Metadata | | SRCDOM | Source Data | Char | CV; LB |
| Set to the SDTM domain name that relates to the analysis value. | | SRCVAR | Source Variable | Char |
|
| Set to the SDTM variable that relates to the analysis value. | | SRCSEQ | Source Sequence Number | Num |
| CV.CVSEQ LB.LBSEQ | Set to the SDTM domain sequence number that relates to the analysis value. |
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| Definexmltable |
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| Dataset | ADCVCMR |
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| Level | Variable |
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| Purpose | Analysis |
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| Name | Variable |
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| Variable Name | Variable Label | Type | Codelist/Controlled Terms/Format | Source | Derivation/Comment |
|---|
| STUDYID | Study Identifier | Char |
| ADCVNTP.STUDYID |
| | USUBJID | Unique Subject Identifier | Char |
| |
| | BRTHDT | Date of Birth | Num | date9. | ADCVNTP.BRTHDT |
| | AGE | Age | Num |
| ADCVNTP.AGE |
| | AGEU | Age Unit | Char | YEARS | ADCVNTPL.AGEU |
| | TRTSDT | Date of First Exposure to Treatment | Num | date9. | ADCVNTP.TRTSDT |
| | TRT01P | Planned Treatment for Period 01 | Char | Drug A; Drug B | ADCVNTP.TRT01P |
| ITTFL | Intent-To-Treat Population Flag | Char | Y; N | ADCVNTP.ITTFL | | | BSASC | Body Surface Area at Screening | Num |
| ADCVNTP.BSASC | | | BSA | Body Surface Area (m2) | Num |
| ADCVNTP.BSA |
| ACEINHFL | ACE Inhibitor Medications Flag | Char | Y; N | ADCVNTP.ACEINHFL |
| BNPPRONT |
| Num |
|
| BNPPRONT = AVAL where PARAMCD = ADCVNTP.BNPPRONT, and merge by USUBJID and AVISITN. Note: there are many ways to add this including transposing the data. | | PARAM | Parameter | Char | Left Ventricular Ejection Fraction, Calculated (%); Right Ventricular Ejection Fraction, Calculated (%); N-Terminal ProB-type Natriuretic Peptide (pg/mL) | ADCVNTP.PARAM | | | PARAMCD | Parameter Code | Char | LVEF_C; RVEF_C; BNPPRONT | ADCVNTP.PARAMCD |
| | PARAMN | Parameter (N) | Num |
| ADCVNTP.PARAMN |
| | AVAL | Analysis Value | Num |
| ADCVNTP.AVAL |
| | AVISIT | Analysis Visit | Char | Visit 1 (Baseline); Visit 6 (1 Year) | ADCVNTP.AVISIT |
| | AVISITN | Analysis Visit (N) | Num | 1; 6 | ADCVNTP.AVISITN |
| | ADT | Analysis Date | Num | date9. | ADCVNTP.ADT |
| | ABLFL | Baseline Record Flag | Char | Y | ADCVNTP.ABLFL |
| | BASE | Baseline Value | Num |
| ADCVNTP.BASE | | | CHG | Change from Baseline | Num |
| ADCVNTP.CHG |
| | PCHG | Percent Change from Baseline | Num |
| ADCVNTP.PCHG |
| | CHGCAT1 | Change from Baseline Category 1 | Char | Decline >=5% ; Decline <5% Increase GT 100 pg/mL | ADCVNTP.CHGCAT1 |
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