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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 |
| |
| | BRTHDT | Date of Birth | Num | date9. | ADSL.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 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 A | ADSL.TRT01P | For this example we are using "Treatment A". In a Real World Evidence study this could be non-treatment related, e.g. "Group A". | ITTFL | Intent-To-Treat Population Flag | Char | Y; N | ADSL.ITTFL | Derive the intent-to-treat population as per the protocol and SAP. | BSABASE | Body Surface Area (m2) at Baseline | Num | ADSL.BSABASE | Set to VS.VSSTRESN in ADSL where VS.VSTESTCD = "BSA" and select for baseline visit. | ACEINHFL | ACE Inhibitor Medications Flag | Char | Y |
| Select a list of ACE inhibitor medications from concomitant medications (CM) domain, and from treatment (EX or EC) domains. 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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| 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. | | ASEQ | Analysis Sequence Number | Num |
| CV.CVSEQ | Number records 1 to n after sorting by keys. | | BRTHDT | Date of Birth | Num | Date9. | ADSL.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.) | | TRT01P | Planned Treatment for Period 01 | Char | Treatment A | ADSL.TRT01P |
| ITTFL | Intent-To-Treat Population Flag | Char | Y; N | ADSL.ITTFL | BSABASE | HEIGHTV | Body Surface Area Height ( | m2cm) at | BaselineVisit | Num | ADSL.BSABASE | Compute in ADSL
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| Set to VS.VSSTRESN where VS. | VSTESTCD | BSAHEIGHT" and merge by visit. | WEIGHTV | Weight (kg) at Visit | Num |
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| Set to VS.VSSTRESN where VS.VSTEST = "WEIGHT" and merge by visit. | ACEINHFL | ACE Inhibitor Medications Flag | Char | Y | Select a list of ACE inhibitor medications from concomitant medications (CM) domain, and from treatment (EX or EC) domains. Code "Y" if the medication was taken during the study. Can be used to subset or to exclude the population who took ACE inhibitors. | | BSA | Body Surface Area (m2) by Visit | Num |
|
| Compute from VS.HEIGHT and VS.WEIGHT fromHEIGHTV and WEIGHTV 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)Takahira, and Schlich). | ACEINHFL | ACE Inhibitor Medications Flag | Char | Y |
| Select a list of ACE inhibitor medications from concomitant medications (CM) domain, and from treatment (EX or EC) domains. Code "Y" if the medication was taken during the study. Can be used to subset or to exclude the population who took ACE inhibitors. | | 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 | LVEFC; RVEFC; BNPPRONT |
| If CV.CVTESTCD = "LVEF_C" then PARAMCD = "LVEFC" If CV.CVTESTCD = "RVEF_C" then PARAMCD = "RVEFC" 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 = "1" RVEFC = "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 |
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| Set to value of CV.VISITNUM or 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 = 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 carrying forward the value of BASE in the baseline record by USUBJID and AVISIT. | | 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 >=10.0; Decline < 10.0; Increase |
| Categorize the value of CHG for Left Ventricular Ejection Fraction, and Calculated (%) (LVEFC) and for Right Ventricular Ejection Fraction, Calculated (%) (RVEFC) | | CHGCAT2 | Change from Baseline Category 2 | Chart |
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| Categorize the value of CHG for N-Terminal ProB-type Natriuretic Peptide (pg/mL) (BNPPRONT) | | SRCDOM | Source Data | Char | CV; LB |
| Set to the SDTM domain name 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 | USUBJID | ASEQ | BRTHDT | TRT01P | ITTFL | BSABASEHEIGHTV | ACEINHFLWEIGHTV | 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-EFLGE-101 | 1 | 15FEB2013 | Treatment A | Y | 119 | 20 | 1.09 | Y1.09 | Left Ventricular Ejection Fraction, Calculated (%) | LVEFC | 1 | 67 | Visit 1 (Baseline) | 1 | VISIT 1 | 16MAY2022 | Y | 67 |
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| CV | 3 | | 2 | DMD-EFLGE | DMD-EFLGE-101 | 2 | 15FEB2013 | Treatment A | Y | 119 | 20 | 1.09 | Y1.09 | Right Ventricular Ejection Fraction, Calculated (%) | RVEFC | 2 | 74 | Visit 1 (Baseline)) | 1 | VISIT 1 | 16MAY2022 | Y | 74 |
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| CV | 7 | | 3 | DMD-EFLGE | DMD-EFLGE-101 | 3 | 15FEB2013 | Treatment A | Y | 1.09119 | Y20 | 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-EFLGE-101 | 4 | 15FEB2013 | Treatment A | Y | 1.09132 | Y32 | 1 1.33 | Y | Left Ventricular Ejection Fraction, Calculated (%) | LVEFC | 1 | 60 | Visit 6 (1 Year) | 6 | VISIT 6 | 06APR2023 |
| 67 | -7 | -10.447761 | Decline >=10.0 | CV | 11 | | 5 | DMD-EFLGE | DMD-EFLGE-101 | 5 | 15FEB2013 | Treatment A | Y | 1.09132 | Y32 | 1.33 | Y | Right Ventricular Ejection Fraction, Calculated (%) | RVEFC | 2 | 61 | Visit 6 (1 Year) | 6 | VISIT 6 | 06APR2023 |
| 74 | -13 | -17.567568 | Decline >=10.0 | CV | 15 | | 6 | DMD-EFLGE | DMD-EFLGE-101 | 6 | 15FEB2013 | Treatment A | Y | 1.09132 | Y32 | 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 |
| 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.
| 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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| Dataset wrap |
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| Dataset2 |
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| | Row | STUDYID | USUBJID | ASEQ | BRTHDT | TRT01P | ITTFL | BSABASEBSA | ACEINHFL | BSA | BNPPRONT | BNPCHG | PARAM | PARAMCD | PARAMN | AVAL | AVISIT | AVISITN | VISIT | ADT | ABLFL | BASE | CHG | PCHG | SRCDOM | SRCSEQ |
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| 1 | DMD-EFLGE | DMD-EFLGE-101 | 1 | 15FEB2013 | Treatment A | Y | 01.6509 | Y | 1.09 | 40 |
| Left Ventricular Ejection Fraction, Calculated (%) | LVEFC | 1 | 67 | Visit 1 (Baseline) | 1 | VISIT 1 | 16MAY2022 | Y | 67 |
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| CV | 3 | | 2 | DMD-EFLGE | DMD-EFLGE-101 | 2 | 15FEB2013 | Treatment A | Y | 01.6509 | Y | 1.09 | 40 |
| Right Ventricular Ejection Fraction, Calculated (%) | RVEFC | 2 | 74 | Visit 1 (Baseline) | 1 | VISIT 1 | 16MAY2022 | Y | 74 |
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| CV | 7 | | 3 | DMD-EFLGE | DMD-EFLGE-101 | 3 | 15FEB2013 | Treatment A | Y | 0 1.6533 | Y | 1.33 | 900 | 2150 | Left Ventricular Ejection Fraction, Calculated (%) | LVEFC | 1 | 60 | Visit 6 (1 Year) | 6 | VISIT 6 | 06APR2023 |
| 67 | -7 | -10.447761 | CV | 11 | | 4 | DMD-EFLGE | DMD-EFLGE-101 | 4 | 15FEB2013 | Treatment A | Y | 01.6533 | Y | 1.33 | 900 | 2150 | Right Ventricular Ejection Fraction, Calculated (%) | RVEFC | 2 | 61 | Visit 6 (1 Year) | 6 | VISIT 6 | 06APR2023 |
| 74 | -13 | -17.567568 | CV | 15 |
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Table 1. A simple comparison of change by treatment groups over one year.
Display | Table 14.xx.xx Percent xx Change in Left Ventricular Ejection Fraction Percent Over 1 Year |
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| Analysis Result | Comparison of Percent Change of Ejection Fraction for the Treatment Groups (1 Year) |
| Analysis Variables(s) | PCHGCHG |
| Analysis Reason | Primary efficacy endpoint as prespecified in the SAP |
| Analysis Purpose | Primary outcome measure |
Data References (incl. selection criteria) | PARAMCD = "LVEFC" 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 */ DATA ONE; SET ADCVCMR; Where ITTFL = "Y" and AVISITN = 2 and PARAMCD = "LREF"; RUN; PROC MEANS DATA=ONE MEAN STD MEDIAN ; CLASS TRT01P; VAR LVEFCHG; /* Could add RVEF here as well */ RUN; |
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Table 2. This table demonstrates a model over multiple time points, adding some of the covariates that were retained in the analysis dataset.
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) | PCHGCHG |
| Analysis Reason | Primary efficacy endpoint as prespecified in the SAP |
| Analysis Purpose | Primary outcome measure |
Data References (incl. selection criteria) | PARAMCD = "LVEFC" 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 PCHG CHG is only computed post-baseline, so subset for the yearly visits, i.e. 6, 12, 18 etc. */ DATA TWO; SET ADCVCMR; IF PARAMCD = "LVEFC"; /* Subset by param, as there are two parameters with CHG calculated*/ Where ITTFL = "Y" and AVISITN = 2;IN(6,12,18,24,36,48) and PARAMCD = "LVEFC"; 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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Display | Table 14.xx.xx Percent change in NTproBNP over 1 Year |
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| Analysis Result | Comparison of Percent Change of NTproBNP for the Treatment Groups Over a period of time. |
| Analysis Variables(s) | PCHG |
| Analysis Reason | Primary efficacy endpoint as prespecified in the SAP |
| Analysis Purpose | Primary outcome measure |
Data References (incl. selection criteria) | PARAMCD = "BNPPRONT" Where ITTFL = "Y" AND AVISIT GE 6; |
| Documentation | The mixed model using lsmeans to compare treatment groups |
Programming Statements (Add programming language statements here: SAS, R, etc.) | /* NEEDS UPDATING*/ PROC MEANS DATA=ADCVCMR MEAN STD MEDIAN maxdec=3; CLASS TRT01P; BY VISIT; VAR BNPPRONT; RUN; |
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