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- From CV domain
- Percent change in ejection fraction over time
- Decline in ejection fraction over a time period (yearly) grouped by a decline greater than x10.x%0%.
- From the LB domain
- Percent change in NTproBNP over a period of time (yearly).
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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 |
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ADSL | Subject-Level Analysis Dataset | SUBJECT LEVEL ANALYSIS DATASET | adsl.xpt | One record per subject | USUBJID | ADaMIG v1.3 section 3.1.1 | | ADCVNTP | Cardiac Ejection Fraction and NTproBNP Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter. | adcvntrp.xpt | USUBJID, AVISITN, PARAMNAnalysis Dataset | ADCMRI | Cardiac Magnetic Resonance Imaging Measurements Summary BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter. | adcmrief.xpt | USUBJID, AVISITN, PARAMN | |
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| 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 ="LVEF_C". | | ADCVNTP | AVAL | PARAMCD = "RVEFC" | Num | Predecessor | Set to CV. CVSTRESN where CV.CVTESTCD ="RVEF_C". | | ADCVNTP | AVAL | PARAMCD = "BNPPRONT" | Num | Predecessor | Set to LB.LBSTRESN where LB.LBTESTCD = "BNPPRONT" |
|
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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. | | BSABASE | Body Surface Area (m2) at Baseline | Num |
| ADSL.BSABASE | Compute in ADSL where VS.VSTESTCD = "BSA". | | 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
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| 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 Number | Num |
|
| Number PARAMCD as follows: "LVEFC = 1" "LVRFC 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 |
|
| 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 |
|
| Set BASE to AVAL from the record for that subject and parameter where ABLFL = "Y". Populate BASE for additional visits by copying the value of BASE in the baseline record by USUBJID and ADT. (Or by AVISIT if ADT varies for labs, where windowing is applied to select record closest to the visit) | | 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 |
|
| Compute PCHG = (CHG / BASE) * 100. Only compute for post-baseline records. | | CHGCAT1 | Change from Baseline Category 1 | Char |
| Decline > | 1=10.0 | (IU/L); Decline < | = 110.0 | (IU/L); Increase; | Categorise 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 |
|
| Categorise the value of CHG for N-Terminal ProB-type Natriuretic Peptide (pg/mL) (BNPPRONT) | | LBSTRNRLO | Reference Range Lower Limit-Std Units | Num | LB.LBSTRNRLO | LBSTRNHI | Reference Range Upper Limit-Std Units | Num | LB.LBSTRNHI | LBNRIND | Reference Range
Indicator | Char | (NRIND) | LB.LBNRIND | 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 Pick other population? POSSIBLE RWE STUDY | | | AGE | Age | Num |
| ADSL.AGE |
| | AGEU | Age Units | Char | (AGEU) | ADSL.AGEU |
| | SEX | Sex | Char | (SEX) | ADSL.SEX |
| | 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. |
|
...
| Dataset wrap |
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| Rowcaps |
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| Rows 1-2: | Show the baseline CMR ejection fraction measurements for participant 101 at VISIT 1. | | Row 3: | Shows the baseline NTProbTest for participant 101 at VISIT 1. | | Rows 4-5: | Show the CMR ejection fraction measurements for participant 101 at VISIT 6. | | Row 6: | Shows the NTProbTest for participant 101 at VISIT 6. |
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| Dataset2 |
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| | Row | STUDYID | USUBJID | ASEQ | BSABASE | PARAM | PARAMCD | PARAMN | AVAL | AVISIT | AVISITN | VISIT | ADT | ABLFL | BASE | CHG | PCHG | CHGCAT1 |
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LBSTRNRLOLBSTRNRHI | LBNRIND | TRT01P | ITTFL | | ITTFL | AGE | AGEU | SEX | SRCDOM | SRCSEQ |
|---|
| 1 | DMD-EFLGE | DMD-EFLGE-101 | 1 | 0.65 | Left Ventricular Ejection Fraction, Calculated (%) | LVEFC | 1 | 67 | Visit 1 (Month 1) | 1 | VISIT 1 | 16May2022 | Y | 67 |
|
|
| Treatment A | Y | 8 | YEARS | M | CV | 3 | | 2 | DMD-EFLGE | DMD-EFLGE-101 | 2 | 0.65 | Right Ventricular Ejection Fraction, Calculated (%) | RVEFC | 2 | 74 | Visit 1 (Month 1) | 1 | VISIT 1 | 16May2022 | Y | 74 |
|
|
| Treatment A | Y | 8 | YEARS | M | CV | 7 | | 3 | DMD-EFLGE | DMD-EFLGE-101 | 3 | 0.65 | N-Terminal ProB-type Natriuretic Peptide (IU/L) | BNPPRONT | 3 | 40 | Visit 1 (Baseline) | 1 | VISIT 1 | 16May2022 | Y | 40 |
10040 | NORMAL |
|
|
| Treatment A | Y | 8 | YEARS | M | LB | 1 | | 4 | DMD-EFLGE | DMD-EFLGE-101 | 4 | 0.65 | Left Ventricular Ejection Fraction, Calculated (%) | LVEFC | 1 | 60 | Visit 6 (Month 12) | 6 | VISIT 6 | 01Jun2023 |
| 67 | -7 | -10.447761 | Decline >=10.0 | Treatment A | Y | 8 | YEARS | M | CV | 11 | | 5 | DMD-EFLGE | DMD-EFLGE-101 | 5 | 0.65 | Right Ventricular Ejection Fraction, Calculated (%) | RVEFC | 2 | 61 | Visit 6 (Month 12) | 6 | VISIT 6 | 01Jun2023 |
| 74 | -13 | -17.567568 | Decline >=10.0 | Treatment A | Y | 8 | YEARS | M | CV | 15 | | 6 | DMD-EFLGE | DMD-EFLGE-101 | 6 | 0.65 | N-Terminal ProB-type Natriuretic Peptide (IU/L) | BNPPRONT | 3 | 900 | Visit 6 (1 Year) | 6 | VISIT 1 | 1Jun2023 |
| 40 | 860 |
2150 | > 1.0 (IU/L) | 100 | 900 | HIGH | | 2,150 |
| Treatment A | Y | 8 | YEARS | M | LB | 2 |
|
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Example 2
The dataset above can also be set up to provide multivariate analyses by taking the lab tests of interest, transposing and merging with the ADCVNTPP dataset. In that case, the records from LB are not needed as a row.
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| Dataset | Value | Where | Variable | Variable Label |
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| ADCVNTP | AVAL | PARAMCD ="BNPPRONT" | BNPPRONT | N-Terminal ProB-type Natriuretic Peptide (IU/L) |
| ADCVNTP | CHGCAT1CHG | PARAMCD ="BNPPRONT" | BNPPRCHGBNPCHG | N-Term ProB-type N Pep Change Category |
| Dataset wrap |
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|
| Dataset2 |
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| | Row | STUDYID | USUBJID | ASEQ | BSABASE | BNPPRONT | BNPPRCHGBNPCHG | PARAM | PARAMCD | PARAMN | AVAL | AVISIT | AVISITN | VISIT | ADT | ABLFL | BASE | CHG | PCHG | TRT01P | ITTFL | AGE | AGEU | SEX | SRCDOM | SRCSEQ |
|---|
| 1 | DMD-EFLGE | DMD-EFLGE-101 | 1 | 0.65 | 40 |
| Left Ventricular Ejection Fraction, Calculated (%) | LVEFC | 1 | 67 | Visit 1 (Month 1) | 1 | VISIT 1 | 16May202216MAY2022 | Y | 67 |
|
| Treatment A | Y | 8 | YEARS | M | CV | 3 | | 2 | DMD-EFLGE | DMD-EFLGE-101 | 2 | 0.65 | 40 |
| Right Ventricular Ejection Fraction, Calculated (%) | RVEFC | 2 | 74 | Visit 1 (Month 1) | 1 | VISIT 1 | 16May202216MAY2022 | Y | 74 |
|
| Treatment A | Y | 8 | YEARS | M | CV | 7 | | 3 | DMD-EFLGE | DMD-EFLGE-101 | 3 | 0.65 | 900 | > 1.0 (IU/L) | 2150 | Left Ventricular Ejection Fraction, Calculated (%) | LVEFC | 1 | 60 | Visit 6 (Month 12) | 6 | VISIT 6 | 01Jun202301JUN2023 |
| 67 | -7 | -10.447761 | Treatment A | Y | 8 | YEARS | M | CV | 11 | | 4 | DMD-EFLGE | DMD-EFLGE-101 | 4 | 0.65 | 900 | > 1.0 (IU/L)2150 | Right Ventricular Ejection Fraction, Calculated (%) | RVEFC | 2 | 61 | Visit 6 (Month 12) | 6 | VISIT 6 | 01Jun202301JUN2023 |
| 74 | -13 | -17.567568 | Treatment A | Y | 8 | YEARS | M | CV | 15 |
|
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Example Analysis Results Metadata (ARM)
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Tables
This table may be included in the submission package for regulatory agencies. It describes the analyses conducted for the study (usually limited to primary and secondary endpoints) with details on data and analysis procedures used. The example below would be repeated for each additional parameter, i.e first example uses the dataset ADCVNTPR, selecting for the parameter "N-Terminal ProB-type Natriuretic Peptide (IU/L)" .
Display | Table 14.xx.xx Percent change in NTproBNP over a period of time (yearly) |
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| Analysis Result | Comparison of Percent Change of NTproBNP for the Treatment Groups Over Time (quarterly or yearly) |
| 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" |
| Documentation | The mixed model using lsmeans to compare treatment groups |
Programming Statements (Add programming language statements here: SAS, R, etc.) | PROC MIXED DATA=ADCVNTPR; WHERE PARAMCD = "BNPPRONT"; CLASS STUYDID TRT01P AVISITN; MODEL PCHG=AVISITN*TRT01P/Solution; RANDOM INTERCEPT / SUBJECT=STUYDID TYPE=UN; LSMEANS TRT01P*AVISITN/ CL PDIFF; RUN; |
Display | Table 14.xx.xx Percent Change in Left Ventricular Ejection Fraction Over Tme |
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| Analysis Result | Comparison of Percent Change of Ejection Fraction for the Treatment Groups Over Time (quarterly or yearly) |
| 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 = "LVEFC" Where ITTFL = "Y" |
| Documentation | The mixed model using lsmeans to compare treatment groups |
Programming Statements (Add programming language statements here: SAS, R, etc.) | 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; |
| Info |
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Ejection Fraction - change in ejection fraction, would expect a decline in EF 2-3% per year, would prefer an improvement or no change. Concerning if rapid progression, 10% decline or more, for example.
NTproBNP - % change over a period of time – a decrease would mean improvement, annually is appropriate
SDTM Examples: Basic CMR tests - Systolic Function |
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