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Questions: - Is screening considered visit 1, or is it to include the subject into the study? SDTM team agreed to change to VISIT 1 instead of SCREENING.
- Are these Real World Evidence (RWE) studies only or clinical trials?
- Should both endpoints be shown in one efficacy dataset or two? I will be showing 3 datasets.
- What is a good surface area to use for the child subject?
- Should i use Male and 6 years? please advise.
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This example section illustrates example analysis datasets for the following endpoints:
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- Percent change in ejection fraction over time
- Decline in ejection fraction over a time period (yearly1 year) grouped by a decline greater than 10.0%.
- From the LB domainPercent change in NTproBNP over a period of time (yearly1 year).
Source Data
The SDTM examples used as the source data are from Section 2.1, Basic CMR Tests - Systolic Function. The CV dataset 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 ptential potential covariate in each row for the last analysis. As in all ADaM datasets, the Subject Level Analysis Dataset (ADSL) was merged in to the SDTM datasets to capture all the necessary demographics, treatments and other required variables for analysis of the data.
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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 | adsl.xpt | 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, PARAMN | |
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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 (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 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 |
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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) | | 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 | | | 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. |
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| 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 | TRT01P | ITTFL | AGE | AGEU | SEX | SRCDOM | SRCSEQ |
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| 1 | DMD-EFLGE | DMD-EFLGE-101 | 1 | 0.65 | Left Ventricular Ejection Fraction, Calculated (%) | LVEFC | 1 | 67 | Visit 1 (Month 1Baseline) | 1 | VISIT 1 | 16May202216MAY2022 | Y | 67 |
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| 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 1Baseline)) | 1 | VISIT 1 | 16May202216MAY2022 | Y | 74 |
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| 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 | 16May202216MAY2022 | Y | 40 |
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| 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 121 Year) | 6 | VISIT 6 | 01Jun202301JUN2023 |
| 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 121 Year) | 6 | VISIT 6 | 01Jun202301JUN2023 |
| 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 | 1Jun202301JUN2023 |
| 40 | 860 | 2,150 |
| Treatment A | Y | 8 | YEARS | M | LB | 2 |
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| Dataset wrap |
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| Dataset2 |
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| | Row | STUDYID | USUBJID | ASEQ | BSABASE | BNPPRONT | BNPCHG | PARAM | PARAMCD | PARAMN | AVAL | AVISIT | AVISITN | VISIT | ADT | ABLFL | BASE | CHG | PCHG | TRT01P | ITTFL | AGE | AGEU | SEX | SRCDOM | SRCSEQ |
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| 1 | DMD-EFLGE | DMD-EFLGE-101 | 1 | 0.65 | 40 |
| Left Ventricular Ejection Fraction, Calculated (%) | LVEFC | 1 | 67 | Visit 1 (Month 1Baseline) | 1 | VISIT 1 | 16MAY2022 | Y | 67 |
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| 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 1Baseline) | 1 | VISIT 1 | 16MAY2022 | Y | 74 |
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| Treatment A | Y | 8 | YEARS | M | CV | 7 | | 3 | DMD-EFLGE | DMD-EFLGE-101 | 3 | 0.65 | 900 | 2150 | Left Ventricular Ejection Fraction, Calculated (%) | LVEFC | 1 | 60 | Visit 6 (Month 121 Year) | 6 | VISIT 6 | 01JUN2023 |
| 67 | -7 | -10.447761 | Treatment A | Y | 8 | YEARS | M | CV | 11 | | 4 | DMD-EFLGE | DMD-EFLGE-101 | 4 | 0.65 | 900 | 2150 | Right Ventricular Ejection Fraction, Calculated (%) | RVEFC | 2 | 61 | Visit 6 (Month 121 Year) | 6 | VISIT 6 | 01JUN2023 |
| 74 | -13 | -17.567568 | Treatment A | Y | 8 | YEARS | M | CV | 15 |
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