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| Definexmltable |
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| Multiple | true |
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| Level | Dataset |
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| Purpose | Analysis |
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Dataset Name | Dataset Description | Class of Dataset | Structure | Location | Keys | Documentation | Location |
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ADSL | Subject-Level Analysis Dataset | SUBJECT LEVEL ANALYSIS DATASET | One record per subject | USUBJID | ADaMIG | adsl.xpt | USUBJID | ADaMIG | | ADCVNTP | Cardiac Ejection Fraction and NTproBNP Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameteradcvntp.xpt | USUBJID, AVISITN, PARAMN | | adcvntp.xpt | | ADCVCMR | Cardiovascular CMR Ejection Fraction Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameteradcvcmr.xpt | USUBJID, AVISITN, PARAMN | | adcvcmr.xpt |
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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 (BSABL), was derived from the LB dataset at the baseline visit and added to ADSL.
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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 |
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| STUDYID | Study Identifier | Char |
| DM.STUDYID |
| | USUBJID | Unique Subject Identifier | Char |
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| | BRTHDT | Date of Birth | Num | date9. | DM.BRTHDTC | Convert BRTHDTC from ISO 8601 format to numeric date. (Note that if exact date is not found then use two variables to capture year and month.) | | TRTSDT | Date of First Exposure to TreatmentAGE |
| Num | date9. | Date portion of DM.RFSTDTC converted to numeric and displayed in a format such as DATE9. |
| DM.AGE |
| | AGEU |
| Char | YEARS | DM.AGEU |
| SEX |
| Num | M, F | DM.SEX |
| 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. | | TRT01P | Planned Treatment for Period 01 | Char | Treatment Drug A, Treatment Drug B |
| Predecessor; DM.ARM. May be changed to lower case or more descriptive term for use in tables and listings. | 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. |
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| Dataset wrap |
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| Dataset2 |
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| | Row | STUDYID | USUBJID | BRTHDT | TRTSDT | TRT01P | ITTFL | BSABASEBSABL | ACENHFL |
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| 1 | DMD-EFLGE | DMD-EF-EFLGE01-101 | 07FEB2010 | 15FEB2022 | Treatment Drug A | Y | 0.65 | Y | | 2 | DMD-EFLGE |
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| | 3 | DMD-EFLGE |
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| | 4 | DMD-EFLGE |
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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 (BSABASEBSABL), 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 = "LVEFC" | Num | Predecessor | Set to CV.CVSTRESN where CV.CVTESTCD = in ("LVEF_C" | ADCVNTP | AVAL | PARAMCD = "RVEFC", "RVEF_C") | Num | Predecessor | Set to CV.CVSTRESN where to CV.CVTESTCD = "RVEF_C"CVSTRESN | | ADCVNTP | AVAL | PARAMCD = "BNPPRONT" | Num | Predecessor | Set to LB.LBSTRESN where LB.LBTESTCD = "BNPPRONT" | | ADCVNTP | CHGCAT1 | PARAMCD = "LVEFCLVEF_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%" | | ADCVNTP | CHGCAT1 | PARAMCD = "RVEFCRVEF_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%" | | ADCVNTP | CHGCAT1 | PARAMCD = "BNPPRONT" |
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| "Increase GT 100 pg/mL" |
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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 |
| | TRT01P | Planned Treatment for Period 01 | Char | Treatment Drug A, Treatment 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. | | BSA | Body Surface Area (m2) | Num |
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| Compute from HEIGHT and WEIGHT by 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 | LVEFCLVEF_C; RVEFCRVEF_C; BNPPRONT |
| If CV.CVTESTCD = "LVEF_C" then PARAMCD = "LVEFCLVEF_C" If CV.CVTESTCD = "RVEF_C" then PARAMCD = "RVEFCRVEF_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: LVEFC LVEF_C = "1" RVEFC RVEF_C = "2" BNPPRONT = "3" | | AVAL | Analysis Value | Num |
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| See Parameter Value List | | AVISIT | Analysis Visit | Char |
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| 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 |
| CV.VISITNUM LB.VISITNUM |
| | VISIT | Visit | Num |
| 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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| Dataset wrap |
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| Rowcaps |
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| Rows 1-2: | Show the baseline ejection fraction measurements at VISIT 1. | | Row 3: | Shows the baseline N-Terminal ProB-type Natriuretic Peptide test results at VISIT 1. | | Rows 4-5: | Show the baseline ejection fraction measurements at VISIT 6. | | Row 6: | Shows the baseline N-Terminal ProB-type Natriuretic Peptide test results at VISIT 6. |
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| Dataset2 |
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| | Row | STUDYID | USUBJIDASEQ | BRTHDT | TRT01P | ITTFL | HEIGHT | WEIGHT | BSA | ACEINHFL | PARAM | PARAMCD | PARAMN | AVAL | AVISIT | AVISITN | VISIT | ADT | ABLFL | BASE | CHG | PCHG | CHGCAT1 | SRCDOM | SRCSEQ |
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| 1 | DMD-EFLGE | DMD-EF-EFLGE01-1011 | 07FEB2010 | Treatment Drug A | Y | 119 | 20 | 1.09 | Y | Left Ventricular Ejection Fraction, Calculated (%) | LVEFCLVEF_C | 1 | 67 | Visit 1 (Baseline) | 1 | VISIT 1 | 16MAY2022 | Y | 67 |
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| CV | 3 | | 2 | DMD-EFLGE | DMD-EF-EFLGE01-1012 | 07FEB2010 | Treatment Drug A | Y | 119 | 20 | 1.09 | Y | Right Ventricular Ejection Fraction, Calculated (%) | RVEFCRVEF_C | 2 | 74 | Visit 1 (Baseline)) | 1 | VISIT 1 | 16MAY2022 | Y | 74 |
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| CV | 7 | | 3 | DMD-EFLGE | DMD-EF-EFLGE01-1013 | 07FEB2010 | Treatment Drug A | Y | 119 | 20 | 1.09 | Y | N-Terminal ProB-type Natriuretic Peptide (IU/L) | BNPPRONT | 3 | 40 | Visit 1 (Baseline) | 1 | VISIT 1 | 16MAY2022 | Y | 40 |
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| LB | 1 | | 4 | DMD-EFLGE | DMD-EF-EFLGE01-1014 | 07FEB2010 | Treatment Drug A | Y | 132 | 32 | 1.33 | Y | Left Ventricular Ejection Fraction, Calculated (%) | LVEFCLVEF_C | 1 | 60 | Visit 6 (1 Year) | 6 | VISIT 6 | 06APR2023 |
| 67 | -7 | -10.447761 | Decline >=5.0% | CV | 11 | | 5 | DMD-EFLGE | DMD-EF-EFLGE01-1015 | 07FEB2010 | Treatment Drug A | Y | 132 | 32 | 1.33 | Y | Right Ventricular Ejection Fraction, Calculated (%) | RVEFCRVEF_C | 2 | 61 | Visit 6 (1 Year) | 6 | VISIT 6 | 06APR2023 |
| 74 | -13 | -17.567568 | Decline >=5.0% | CV | 15 | | 6 | DMD-EFLGE | DMD-EF-EFLGE01-1016 | 07FEB2010 | Treatment Drug A | Y | 132 | 32 | 1.33 | Y | N-Terminal ProB-type Natriuretic Peptide (IU/L) | BNPPRONT | 3 | 900 | Visit 6 (1 Year) | 6 | VISIT 1 | 06APR2023 |
| 40 | 860 | 2,150 | Increase GT 100 pg/mL | LB | 2 |
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The dataset above can also be set up to provide multivariate analyses by taking the lab tests of interest, transposing and merging with the ADCVNTP dataset. In that case, the records from LB are not needed as a row. The stratification variables such as BSA and ACEINHFL are carried over, but not HEIGHTW or WEIGHTW which were used to compute BSA values.values.
/* remove this table and make sure description is above */
| Definexmltable |
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| Dataset | ADCVCMR |
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| Level | Value |
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| Purpose | Analysis |
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| OID | AVAL |
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| Dataset | Value | Where | Variable | Variable Label |
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| ADCVCMR | AVAL | PARAMCD = "BNPPRONT" | BNPPRONT | N-Terminal ProB-type Natriuretic Peptide (IU/L) | | ADCVCMR | CHG | PARAMCD = "BNPPRONT" | BNPCHG | N-Term ProB-type N Pep Change Category |
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| Dataset2 |
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| Row | STUDYID | USUBJID | ASEQ | BRTHDT | TRT01P | ITTFL | BSA | ACEINHFL | BNPPRONT | BNPCHG | PARAM | PARAMCD | PARAMN | AVAL | AVISIT | AVISITN | VISIT | ADT | ABLFL | BASE | CHG | PCHG | SRCDOM | SRCSEQ |
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| 1 | DMD-EFLGE | DMD-EF-EFLGE01-101 | 1 | 07FEB2010 | Treatment Drug A | Y | 1.09 | Y | 40 |
| Left Ventricular Ejection Fraction, Calculated (%) | LVEFCLVEF_C | 1 | 70 | Visit 1 (Baseline) | 1 | VISIT 1 | 16MAY2022 | Y | 70 |
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| CV | 3 | | 2 | DMD-EFLGE | DMD-EF-EFLGE01-101 | 2 | 07FEB2010 | Treatment Drug A | Y | 1.09 | Y | 40 |
| Right Ventricular Ejection Fraction, Calculated (%) | RVEFCRVEF_C | 2 | 75 | Visit 1 (Baseline) | 1 | VISIT 1 | 16MAY2022 | Y | 75 |
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| CV | 7 | | 3 | DMD-EFLGE | DMD-EF-EFLGE01-101 | 3 | 07FEB2010 | Treatment Drug A | Y | 1.33 | Y | 900 | 2150 | Left Ventricular Ejection Fraction, Calculated (%) | LVEFCLVEF_C | 1 | 65 | Visit 6 (1 Year) | 6 | VISIT 6 | 06APR2023 |
| 70 | -5 | -10.447761 | CV | 11 | | 4 | DMD-EFLGE | DMD-EF-EFLGE01-101 | 4 | 07FEB2010 | Treatment Drug A | Y | 1.33 | Y | 900 | 2150 | Right Ventricular Ejection Fraction, Calculated (%) | RVEFCRVEF_C | 2 | 70 | Visit 6 (1 Year) | 6 | VISIT 6 | 06APR2023 |
| 75 | -5 | -17.567568 | CV | 15 |
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Display | Table 14.xx.xx Change in Left Ventricular Ejection Fraction Percent Over 1 Year |
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| Analysis Result | Comparison of Change of Ejection Fraction Percent for the Treatment Groups (1 Year) |
| Analysis Variables(s) | CHG |
| Analysis Reason | Primary efficacy endpoint as prespecified in the SAP |
| Analysis Purpose | Primary outcome measure |
Data References (incl. selection criteria) | PARAMCD = "LVEFCLVEF_C" Where ITTFL = "Y" and AVISITN = 6; |
| Documentation | Comparison of Means with 95% confidence interval |
Programming Statements (Add programming language statements here: SAS, R, etc.) | /* Subset the data. Can run again selecting for paramcd="RVEFCRVEF_C"*/ DATA ONE; SET ADCVCMR; Where ITTFL = "Y" and AVISITN = 6 and PARAMCD = 'LVEFCLVEF_C'; RUN; PROC MEANS DATA=ONE N MEAN clm STDERR; CLASS TRT01P; VAR CHG; RUN; |
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Display | Table 14.xx.xx Percent Change in Left Ventricular Ejection Fraction Percent Over Time (Yearly) |
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| Analysis Result | Comparison of Percent Change of Ejection Fraction for the Treatment Groups Over Time ( yearly) |
| Analysis Variables(s) | CHG |
| Analysis Reason | Primary efficacy endpoint as prespecified in the SAP |
| Analysis Purpose | Primary outcome measure |
Data References (incl. selection criteria) | PARAMCD = "LVEFCLVEF_C" Where ITTFL = "Y" |
| Documentation | The mixed model using lsmeans to compare treatment groups |
Programming Statements (Add programming language statements here: SAS, R, etc.) | /* Note that CHG is only computed post-baseline, so subset for the yearly visits, i.e. 6, 12, 18 etc. */ DATA TWO; SET ADCVCMR; /* Subset by param, as there are two parameters with CHG calculated*/ Where ITTFL = "Y" and AVISITN IN(6,12,18,24,36,48) and PARAMCD = "LVEFCLVEF_C"; RUN;
PROC MIXED DATA=ADCVNTP; CLASS STUYDID TRT01P AVISITN; MODEL PCHG=AVISITN*TRT01P/Solution; RANDOM INTERCEPT / SUBJECT=STUYDID TYPE=UN; LSMEANS TRT01P*AVISITN/ CL PDIFF; RUN; |
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