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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 CVTESTCD = "LVEF_C" and CVTESTCD = "RVEF_C" representing the Ventricular Ejection Fraction, Calculated (%) for left and right were selected for the analysis. The LB dataset test where LBTESTCD = "BNPPRONT" was used to add the value of BNPPRONT to compute the percent change over time, and then it was added as a potential covariate in each row for the last analysis.
Example Analysis Datasets
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The ADSL was combined with other SDTM datasets to create the analysis datasets. More than one SDTM dataset can be combined in this way. Also, stratification variables can be created in the ADSL to subset by, or to add variables needed in the analyses. For example, a flag (ACEMEDFL) could be added for ACE inhibitors. Another variable, body surface area (BSABLBSASC), was derived from the LB dataset VS dataset (using height and weight) at the baseline screening visit and added to ADSL. Note that based on the dates shown in DM, the screening visit and visit 1 have the same dates for this example.
The ADCVNTP dataset includes tests pertinent to these analyses. The ADCVNTP dataset includes tests pertinent to these analyses. The records from CV where CVTESTCD = "LVEF_C" and "RVEF_C" and the records from LB where LBTESTCD = "BNPPRONT" were selected. Many lab draws may occur throughout the year, but only those linked to a specific visit were included. By subsetting the LB dataset by LBLNKID not missing, laboratory data that aligns with CV data can be filtered out and sorted using USUBJID and VISIT. If LBLNKID is not available, a windowing strategy could be used to select the laboratory draw closest to that visit for merging with CV, computed in AVISIT.
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This is a simplified example ADSL dataset; it is expected that additional variables for stratification, or of interest for analysis, would be included. Analysis age was computed from date of birth and The Body Surface Area (BSA) is calculated for screening, and named BSASC as per the ADAMIG v1.2. There are many possible calculations for BSA. For this example, the Du Bois method was used (footnote: https://www.calculator.net/body-surface-area-calculator.html),
| 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 |
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| STUDYID |
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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 Convert BRTHDTC converted to numeric and displayed in a format such as date9.from ISO 8601 format to numeric date. (Note that if exact date is not found then use two variables to capture year and month.)9 | | AAGE | Analysis Age | Num |
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| 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 | AgeAGE | Num |
| DM.AGE |
| | AGEU | Age Units | Char | YEARS | DM.AGEU |
| SEX | Sex | Num | Char | (SEX)M, F | 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. | | DTHDT | | Num | date9. |
| Date portion of DM.RFSTDTC converted to numeric and displayed in a format such as DATE9.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. | ITTFL | Intent-To-Treat Population Flag | Char | Y; | 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, and from treatment (EX or EC) domains as per Statistical Analysis Plan or Protocol. Code "Y" if the medication was taken during the study. Can be used to subset or to exclude the population who took ACE inhibitors.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 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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| Dataset wrap |
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| Dataset2 |
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| | Row | STUDYID | USUBJID | BRTHDT | TRTSDT | TRT01P | ITTFL | BSABL | ACENHFL |
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1 | | Row | STUDYID | USUBJID | BRTHDT | AAGE | AGE | AGEU | SEX | RACE | TRTSDT | RFICDTC | TRT01P | ITTFL | ACENHFL | HEIGHTSC | WEIGHTSC | BSASC |
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| 1 | DMD-EFLGE | DMD-EF-01-101 | 07FEB2010 | 12.3 | 12 | YEARS | M | BLACK OR AFRICAN AMERICAN | 16JUN2022 | 16JUN2022 | Drug A | Y | Y | 119 | 20 | 0.82 | | 2 | DMD-EFLGE | DMD-EF-01-101 | 01MAY2008 | 14.1 | 14 | YEARS | M | ASIAN | 13JUN2022 | 13JUN2022 | Drug A | Y | Y | 115 | 30 | 0,95 | | 3 | DMD-EFLGE | DMD-EF-01-101 | 10JUL2003 | 19.0 | 19 | YEARS | M | NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER | 15JUL22022 | 15JUL2022 | Drug B | Y | N | 140 | 45 | 1,30 | | 4 |
07FEB2010 | 15FEB2022 | Drug A | Y | 0.65 | Y | 2 | DMD-EFLGE | 3 | DMD-EFLGE | 4 | DMD-EFLGE| 15JAN1999 | 23.7 | 23 | YEARS | M | WHITE | 06SEP2022 | 06SEP2022 | Drug B | Y | Y | 132 | 42 | 1,21 |
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ADCVNTP Analysis Dataset
In this example, columns for derived variables BASE, CHG, PCHG and CHGCAT1 have been added to facilitate analyses of the efficacy endpoints. Specifically, example demographic data for ADSL were created for an 8 year old male. Also, a custom variable for BSA at baseline (BSABL), and an example of a stratification variable for subjects with was added from ADSL.
| Definexmltable |
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| Dataset | ADCVNTP |
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| Level | Value |
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| Purpose | Analysis |
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| OID | AVAL |
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| Dataset | Variable | Where | Type | Origin | Derivation/Comment |
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| ADCVNTP | AVAL | PARAMCD in ("LVEF_C", "RVEF_C") | Num | Predecessor | Set to CV.CVSTRESN | | ADCVNTP | AVAL | PARAMCD = "BNPPRONT" | Num | Predecessor | Set to LB.LBSTRESN where LB.LBTESTCD = "BNPPRONT" | ADCVNTP | CHGCAT1 | PARAMCD = "LVEF_C" | Char | Categorize the value of CHG as follows: If CHG >= 5.00 THEN CHGCAT1 = "Decline >=5%". Else if CHG not missing and CHG < 5.00 THEN CHGCAT1 = "Decline <5%LB.LBSTRESN where LB.LBTESTCD = "BNPPRONT" | | ADCVNTP | CHGCAT1 | PARAMCD = in ("LVEF_C", "RVEF_C") | Char |
| Categorize the value of CHG CHGCAT1 as follows: If CHG >= 5.00 THEN CHGCAT1 = "Decline >=5%". Else if CHG not missing and CHG < 5.00 THEN CHGCAT1 = "Decline <5%" | | ADCVNTP | CHGCAT1 | PARAMCD = "BNPPRONT" | Char |
| "Increase GT Categorize the value of CHCAT1 as follows:"Increase >100 pg/mL", "Increase <=100 pg/mL" "No increase" |
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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 |
| | Select for records with RE data. | | BRTHDT | Date of Birth | Num | Date9. | ADSL.BRTHDT | BRTHDT |
| | AAGE | Analysis AgeDate of Birth | Num | Date9. |
| ADSL.AAGE |
| | AGEU | Age Unit | Char | YEARS | ADSL.AGEU |
| | TRTSDT | |
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| | RFICDTADSL.BRTHDT | |
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| | TRT01P | Planned Treatment for Period 01 | Char | Drug A, Drug B | ADSL.TRT01P |
| ITTFL | Intent-To-Treat Population Flag | Char | Y; N | ADSL.ITTFL | | HEIGHT | Height (cm) | Num |
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| Set to VS.VSSTRESN where VS.VSTEST = "HEIGHT" and merge by visit. | WEIGHT | Weight (kg) | Num |
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| Set to VS.VSSTRESN where VS.VSTEST = "WEIGHT" and merge by visit. | | BSASC | Body Surface Area at Screening | Num |
| ADSL.BSASC | | | BSA | Body Surface Area (m2) | Num |
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| Compute from HEIGHT and WEIGHT by at each visit, using the Du Bois method. BSA = 0.007184 × W0.425 × H0.725 Note that 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 |
| If CV.CVTESTCD = "LVEF_C" then PARAMCD = "LVEF_C" If CV.CVTESTCD = "RVEF_C" then PARAMCD = "RVEF_C" If LB.LBTESTDC = "BNPPRONT" then PARAMCD = "BNPPRONT" Note: for this example dataset, select the records where the test values shown above 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 List | | AVISIT | Analysis Visit | Char | Visit 1 (Baseline) Visit 6 (1 Year) |
| If CV.VISIT = "VISIT 1" then AVISIT = "Visit 1 (Baseline)". Else 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
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| See PVLM table. | | SRCDOM | Source Data | Char | CV; LB |
| Set to the SDTM domain name that relates to the analysis value. | | SRCVAR | Source Variable | Char |
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| 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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