The data from the SDTM examples for ejection fraction can be used for multiple endpoint analyses. For this example we show the following endpoints:
- From CV domain
- Percent change in ejection fraction
- Decline in ejection fraction over a time period (yearly) grouped by a decline greater than x.x%.
- From the LB domain
- Percent change in NTproBNP over a period of time (yearly).
The SDTM examples are in the section Basic CMR tests -Systolic Function (make link) . The example datasets show visits 1 and 6 for one subject. As mentioned in the SDTM text, for the purposes of this example, the participant 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.
Questions.
Is screening considered visit 1, or is it to include the subject into the study?
Are these Real World Evidence (RWE) studies only or clinical trials?
Should both endpoints be shown in one efficacy dataset or two?
Analysis Datasets
Dataset Name | Dataset Description | Class of Dataset | Structure | Location | Keys | Documentation |
|---|---|---|---|---|---|---|
ADSL | Subject-Level Analysis Dataset | SUBJECT LEVEL ANALYSIS DATASET | adsl.xpt | One record per subject | USUBJID | ADaMIG v1.3 section 3.1.1 |
| ADCVEF | Cardiac Ejection Fraction Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter. | adcvef.xpt | USUBJID, AVISITN, PARAMCD | Analysis Dataset |
| ADNTRPO | Cardia NTproBNP Laboratory Analyis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter. | adntpro.xpt | USUBJID, AVISITN, PARAMCD | Analysis Dataset |
| ADCMRI | Cardiac Magnetic Resonance Imaging Measurements Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter. | adcmri.xpt | USUBJID, AVISITN, PARAMCD | Analysis Dataset |
ADCV Analysis Dataset
This example analysis dataset used the SDTM CV dataset for input which shows the findings associated with a Cardiac Magnetic Resonance Imaging procedure related to ejection fraction.
CVDTC is the date of the CMR procedure, CVDY is the study. For the purposes of this example, the participant was enrolled in the study on 20-May-2021 and the study visits were every twp months.The CVLNKID variable is used to identify a record to show a relationship between records in separate domains.
The following are the parameters for the example ADaM datasets. Note that the columns for derived variables, BASE, and CHG have been added, as well as selected variables from ADSL. The rows needed from the spirometry and 6MWT for ranking change from baseline were created in the safety analysis datasets. These derived rows were then copied to ADCOMPOS. The ADCOMPOS example shows the final rows required.
ADSPIRO Variable Metadata
| Variable Name | Variable Label | Type | Codelist/Controlled Terms/Format | Source | Derivation/Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | Char | CV.STUDYID | ||
| USUBJID | Unique Subject Identifier | Char | CV.USUBJID | Select for records with RE data. | |
| ASEQ | Analysis Sequence Number | Num | Sequence number given to ensure uniqueness of subject records within an ADaM dataset. Number the records 1 to n after sorting by the key variables. | ||
| TRT01P | Planned Treatment for Period 01 | Char | ADSL.TRT01P | ||
COMPLFL | Completers Population Flag | Char | Y; N | ADSL.COMPLFL | |
| AGE | Age | Num | ADSL.AGE | ||
| AGEU | Age Units | Char | (AGEU) | ADSL.AGEU | |
| SEX | Sex | Char | (SEX) | ADSL.SEX | |
| PARAM | Parameter | Char | Left Ventricular Ejection Fraction, Calculated (%) Right Ventricular Ejection Fraction, Calculated (%) N-Terminal ProB-type Natriuretic Peptide (pg/mL) | Move to PVLM Table Set to "CV.CVTEST" plus "(CV.CVTESTU)" with spaces and parentheses as shown. Set to "LB.LBTEST" plus "(CV.CVTESTU)" 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.LBTESTCD = "BNPPRONT" then PARAMCD = "BNPPRONT"
| |
| AVAL | Analysis Value | Num | Set to value of CV.CVSTRESN. Set to value of LB.LBSTRESN. | ||
| AVISIT | Analysis Visit | Char | ?????? | If CV.VISIT = "SCREENING" then AVISIT = "XXX". Else if CV.VISIT = "VISIT 6" then AVISIT = "XXXX". | |
| AVISITN | Analysis Visit (N) | Num | 1, 6 | Set to value of CV.VISITNUM. | |
| VISIT | Visit | Char | CV.VISIT | ||
| ADT | Analysis Date | Num | date9. | Date portion of CV.CVDTC converted to numeric and displayed in a format such as date9. Date in SDTM represents date of CMR procedure. | |
| ABLFL | Baseline Record Flag | Char | Y | Check on visit numbering If VISIT = 1 then ABLFL = "Y". | |
| BASE | Baseline Value | Num | Set BASE to AVAL from the record for that subject and parameter where ABLFL = "Y". | ||
| CHG | Change from Baseline | Num | Compute CHG = AVAL - BASE for that record. Only compute for post-baseline records. | ||
| PCHG | Percent Change from Baseline | Num | PCHG = (CHG / BASE) * 100 | ||
| CHGCAT1 | Change from Baseline Category 1 | >1 g/dL; <=1 g/dL | |||
| 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. |
Parameter Value List - ADSPIRO, AD6MWT, ADCOMPOS
| Dataset | Variable | Where | Type | Origin | Derivation/Comment |
|---|---|---|---|---|---|
| ADCMRI | AVAL | PARAMCD = " XXXX" | Num | Derived | Within each component (FVCPP), the change from baseline value is sorted by lowest CHG, then ranked across all pooled subjects. The lowest change value is assigned a rank of 1, the next lowest a rank of 2, and so on. |
| ADCMRI | AVAL | PARAMCD = "XXXX" | Num | Predecessor | Set to CV.CVSTRESN where CV.CVTESTCD = "FVC". |
| ADCMRI | AVAL | PARAMCD = "NTPROBNP" | Num | Predecessor | Set to CV.CVSTRESN where CV.CVTESTCD = "FVCPP". |
Dataset Wrapper Debug Message
Please add a row column to your dataset.
(Copied from the SDTM page for reference until I create the sample ADaM dataset
Dataset Wrapper Debug Message
Please add a row column to your dataset.
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