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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 10.0%.
- From the LB domain
- Percent change in NTproBNP over a period of time (yearly).
Source Data
The SDTM examples used as the source data are from Section 2.1, Basic CMR tests Tests - Systolic Function. The example datasets show visits 1 and 6 for one subject. The subject was enrolled in the study on 20-May-2021 and the study visits were every two months. Visit 1 represents the visit at day 1 of the study, and visit 6 represents the visit at month 12 of the study. The associated laboratory test, N-Terminal ProB-type Natriuretic Peptide, is used in conjunction with ejection fraction as a biomarker and is important for diagnosis and treatment. It is also used separately to identify the percent change over a period of time.
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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 |
|---|
| 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;
|
| 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(N) | Num |
|
| Number PARAMCD as follows: LVEFC = "1" RVEFC = "2" BNPPRONT = "3" | | AVAL | Analysis Value | Num |
|
| See Parameter Value List | | AVISIT | Analysis Visit | Char |
|
| 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 |
|
| 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 >=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 |
|
| 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-toTo-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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| 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 Tests - Systolic Function |