Measuring LVEF regularly can show the rate of decline in left ventricle function for a patient with DMD. Therefore, it was selected as an endpoint for this example to measure whether a course of therapy may slow the progression of heart failure for the patient. The second endpoint chosen, NT-proBNP, is a biomarker that may be used to predict or diagnose heart failure.
This section illustrates example analysis datasets for the following endpoints:
The data from the SDTM examples for ejection fraction can be used for multiple endpoint analyses. For this example we show the following endpoints:
...
- Percent change in ejection fraction over time (1 year)
- Decline in ejection fraction over a time period (yearly1 year) grouped by a decline greater than x-5.x%.0%
- From the LB domainPercent change in NTproBNP over a period of NT-proBNP over time (yearly).
The example study
For this example we show the following endpoints from the SDTM dataset:
- CV - Percent change in ejection fraction, decline in EF over a time period (yearly) grouped by declinde greater than x%.
- LB - Percent change in NTproBNP over a period of time (yearly)
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?
Source Data
The SDTM examples used as the source data are from Section 2.1, Basic Systolic Function. The records in the CV dataset for which CVTESTCD = "LVEF_C" and "RVEF_C" were selected for analysis. The records in the LB dataset where LBTESTCD = "BNPPRONT" were used to compute the percent change over time and as a potential covariate. Both SDTM domains are used in one analysis dataset to demonstrate the flexibility of ADaM and to show that the various SDTM domains can be combined into one dataset both as rows and also as covariates.
Example Analysis Datasets
The following tables show the analysis dataset metadata and parameters used for this example.
-Should both endpoints be shown in one efficacy dataset or two?
| Definexmltable |
|---|
| Multiple | true |
|---|
| Level | Dataset |
|---|
| Purpose | Analysis |
|---|
|
Dataset Name | Dataset Description | Class of Dataset | Structure | LocationPurpose | Keys | Location | Documentation |
|---|
ADSL | Subject-Level Analysis Dataset | SUBJECT LEVEL ANALYSIS DATASETadsl.xpt | One record per subject. | Analysis | USUBJID | ADaMIG v1.3 section 3.1.1 | adsl.xpt | ADSL.SAS | | ADEFNTP | CV MRI EF and NT-proBNP Analysis | ADCVEF | Cardiac Ejection Fraction Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter. | adcvef.xptAnalysis | USUBJID, AVISITN, PARAMCD | | PARAMN | adefntp.xpt | | | ADEFMRI | CV MRI Ejection Fraction Analysis | ADNTRPO | Cardia NTproBNP Laboratory Analyis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter. | adntpro.xptAnalysis | USUBJID, AVISITN, PARAMCD | | | 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 | |
|
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.
ADSL
The ADSL contains subject characteristics and covariates that are important for analyses. Stratification variables can be created in the ADSL to subset the data. More than one SDTM dataset may be used as input to the ADSL. This is a simplified example ADSL dataset; the ADaMIG should be referenced for additional variables.
For this example:
- Analysis age (AAGE) was included to provide age with more precision.
- A flag indicating the use of ACE inhibitors (ACEINHFL) is shown with example derivation from the CM dataset.
- Body surface area at screening (BSASC) was derived from the VS dataset using height and weight at the screening visit. There are many possible calculations for BSA; for this example, the Du Bois method was used.[11] Note that the screening visit and visit 1 occurred at the same time in this example.
| Definexmltable |
|---|
|
| Definexmltable |
|---|
| Dataset | ADSPIRO |
|---|
| Level | Variable |
|---|
| Purpose | Analysis |
|---|
| Name | Variable |
|---|
|
| Variable Name | Variable Label | Type | Codelist/Controlled Terms/Format | Source/Derivation/Comment |
|---|
| STUDYID | Study Identifier | Chartext |
| CVPredecessor: DM.STUDYID | | USUBJID | Unique Subject Identifier | Chartext |
| CVPredecessor: DM.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" Set to value of CV.CVTESTCD.
| 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 | | 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. |
|
| Definexmltable |
|---|
| Multiple | true |
|---|
| Dataset | ADSPIRO, AD6MWT, ADCOMPOS |
|---|
| Level | Value |
|---|
| Purpose | Analysis |
|---|
| OID | AVAL |
|---|
| Name | Parameter Value List - ADCOMPOS |
|---|
|
| BRTHDT | Date of Birth | integer | yymmdd10. | Derived: Date portion of DM.BRTHDTC converted to numeric and displayed in a format, such as yymmdd10. | | AAGE | Analysis Age | float |
| Derived: Age as screening, computed by DM.RFICDTC - BRTHDTC as continuous variable. Note that some countries do not allow capturing date of birth, so this could be computed by capturing age in years and months on a CRF. | | AGE | Age | integer |
| Predecessor: DM.AGE | | AGEU | Age Units | text | YEARS | Predecessor: DM.AGEU | SEX | Sex | text | (SEX) | Predecessor: DM.SEX | RACE | Race | text | (RACE) | Predecessor: DM.RACE | | TRTSDT | Date of First Exposure to Treatment | integer | yymmdd10. | Derived: Date portion of DM.RFSTDTC converted to numeric and displayed in a format such as yymmdd10. | | RFICDT | | integer | yymmdd10. | Derived: Date portion of DM.RFICDTC converted to numeric and displayed in a format such as yymmdd10. | | DTHDT | | integer | yymmdd10. | Derived: Date portion of DM.DTHDT converted to numeric and displayed in a format such as yymmdd10. | | DTHFL | | text | Y | Predecessor: DM.DTHFL | | TRT01P | Planned Treatment for Period 01 | text | Drug A; Drug B | Predecessor: DM.ARM. May be changed to lower case or more descriptive term for use in tables and listings. | | TRT01A | Actual Treatment for Period 01 | text | Drug A; Drug B | Predecessor: DM.ACTARM. Note: Actual treatment matches planned treatment unless there is a reason subject does not take planned drug. | ITTFL | Intent-To-Treat Population Flag | text | Y; N | Derived: Derive the intent-to-treat population as per the protocol and SAP. | ACEINHFL | ACE Inhibitor Medications Flag | text | Y; N | Derived: Select a list of ACE inhibitor medications from concomitant medications (CM) domain as per SAP or protocol. Set to "Y" if these medications were taken during the study, and "N" if they are absent. Can be used to subset or to exclude the population who took ACE inhibitors. | HEIGHTSC | Height (cm) at Screening | float |
| Predecessor: Set to VS.VSSTRESN where VS.VSTESTCD = "HEIGHT" and VISITNUM= 1 (or screening visit). | WEIGHTSC | Weight (kg) at Screening | float |
| Predecessor: Set to VS.VSSTRESN where VS.VSTESTCD = "WEIGHT" and VISITNUM = 1 (or screening visit). | BSASC | Body Surface Area at Screening | float |
| Derived: Select where VISITNUM = 1 (or screening visit). Compute from HEIGHT and WEIGHT, using the Du Bois method. BSA = 0.007184 × W0.425 × H0.725 There are multiple methods for calculating BSA (e.g., Du Bois, Mosteller, Haycock, Gehan & George, Boyd, Fujimoto, Takahira, Schlich); the study protocol should describe which to use. |
|
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| | Row | STUDYID | USUBJID | BRTHDT | AAGE | AGE | AGEU | SEX | RACE | TRTSDT | RFICDT | DTHDT | DTHFL | TRT01P | ITTFL | ACEINHFL | HEIGHTSC | WEIGHTSC | BSASC |
|---|
| 1 | DMD-EFLGE | DMD-EF-01-101 | 2010-02-07 | 12.3 | 12 | YEARS | M | BLACK OR AFRICAN AMERICAN | 2022-06-16 | 2022-06-16 |
|
| Drug A | Y | Y | 119 | 20 | 0.82 | | 2 | DMD-EFLGE | DMD-EF-01-101 | 2008-05-01 | 14.1 | 14 | YEARS | M | ASIAN | 2022-06-13 | 2022-06-13 |
|
| Drug A | Y | Y | 115 | 30 | 0.95 | | 3 | DMD-EFLGE | DMD-EF-01-101 | 2003-07-10 | 19.0 | 19 | YEARS | M | NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER | | 2022-07-15 |
|
| Drug B | Y | N | 140 | 45 | 1.30 | | 4 | DMD-EFLGE | DMD-EF-01-101 | 1999-01-15 | 23.7 | 23 | YEARS | M | WHITE | 2022-09-06 | 2022-09-06 | 2023-11-23 | Y | Drug B | Y | Y | 132 | 42 | 1.21 |
|
|
ADEFNTP
The ADEFNTP includes tests pertinent to analyses. The records from CV (CVTESTCD = "LVEF_C" and "RVEF_C") and the records from LB (LBTESTCD = "BNPPRONT") were selected. Many lab draws may occur throughout the year, but only those linked to a specific visit were included. By subsetting the LB dataset by LBLNKID not missing, laboratory data that aligns with CV data can be filtered out and sorted using USUBJID and VISIT. If LBLNKID is not available or the LB dataset does not contain VISIT, a windowing strategy could be used to select the laboratory draw closest to that visit using date of lab draw (LB.LBDTC.).
| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-8 |
|---|
|
| Definexmltable |
|---|
| Dataset | ADEFNTP |
|---|
| Level | Variable |
|---|
| Purpose | Analysis |
|---|
| Name | Variable |
|---|
|
| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Source/Derivation/Comment |
|---|
| STUDYID | Study Identifier | text |
| Predecessor: CV.STUDYID | | USUBJID | Unique Subject Identifier | text |
| Predecessor: CV.USUBJID | | BRTHDT | Date of Birth | integer | yymmdd10. | Predecessor: ADSL.BRTHDT | | AAGE | Analysis Age | float |
| Predecessor: ADSL.AAGE | | AGEU | Age Unit | text |
|
Predecessor: ADSL.AGEU | SEX | Sex | text | (SEX) | | RACE | Race | text | (RACE) | Predecessor: ADSL.RACE | | TRTSDT | Date of First Exposure to Treatment | integer | yymmdd10. | Predecessor: ADSL.TRTSDT | | TRT01P | Planned Treatment for Period 01 | text | Drug A; Drug B | Predecessor: ADSL.TRT01P | | TRT01A | Actual Treatment for Period 01 | text | Drug A; Drug B | Predecessor: ADSL.TRT01A | ITTFL | Intent-To-Treat Population Flag | text | Y; N | | HEIGHT | Height (cm) | float |
| Set to VS.VSSTRESN where VS.VSTEST = "HEIGHT" by visit. | WEIGHT | Weight (kg) | float |
| Set to VS.VSSTRESN where VS.VSTEST = "WEIGHT" by visit. | | BSA | Body Surface Area (m2) | float |
| Derived: Compute from HEIGHT and WEIGHT at each visit, using the Du Bois method. BSA = 0.007184 × W0.425 × H0.725 There are multiple methods for calculating BSA; the study protocol should describe which to use. | ACEINHFL | ACE Inhibitor Medications Flag | text | Y; N | Predecessor: ADSL.ACEINHFL | | PARAM | Parameter | text | Left Ventricular Ejection Fraction, Cal (%); Right Ventricular Ejection Fraction, Cal (%); N-Terminal ProB-type Natriuretic Peptide (ng/L) | Predecessor: CV.CVTEST LB.LBTEST | | PARAMCD | Parameter Code | text | LVEF_C; RVEF_C; BNPPRONT | Predecessor: CV.CVTESTCD LB.LBTESTCD | | PARAMN | Parameter (N) | integer | 1; 2; 3 | Assigned: Number PARAMCD as follows: LVEF_C = "1" RVEF_C = "2" BNPPRONT = "3" | | AVAL | Analysis Value | float |
| See Parameter Value Metadata | | AVISIT | Analysis Visit | text | Visit 1 (Baseline); Visit 6 (1 Year) | If CV.VISIT = "VISIT 1" then AVISIT = "Visit 1 (Baseline)". If CV.VISIT = "VISIT 6" then AVISIT = "Visit 6 (1 Year)". | | AVISITN | Analysis Visit (N) | integer | 1; 6 | Predecessor: CV.VISITNUM LB.VISITNUM | | VISIT | Visit | integer | VISIT 1; VISIT 6 | Predecessor: CV.VISIT LB.VISIT | | ADT | Analysis Date | integer | yymmdd10. | Date portion of CV.CVDTC or LB.LBDTC converted to numeric and displayed in a format such as yymmdd10. | | ABLFL | Baseline Record Flag | text | Y | Derived: If CV.VISIT = "VISIT 1" then ABLFL = "Y". | | BASE | Baseline Value | float |
| Derived: Set BASE to AVAL from the record for that subject and parameter where ABLFL = "Y". Populate BASE for additional visits by merging the value of BASE in the baseline record by USUBJID and PARAMCD. | | CHG | Change from Baseline | float |
| Derived: Compute CHG = AVAL - BASE for that record. Only compute for post-baseline records. | | PCHG | Percent Change from Baseline | float |
| Derived: Compute PCHG = (CHG / BASE) * 100. Only compute for post-baseline records. | | CHGCAT1 | Change from Baseline Category 1 | text | Decline >=-5.0%; Decline <-5.0%; No Decline | See Parameter Value Metadata | | SRCDOM | Source Data | text | CV; LB | Assigned: Set to the SDTM domain name that relates to the analysis value. | | SRCVAR | Source Variable | text | CVSTRESN; LBSTRESN | Assigned: Set to the SDTM variable that relates to the analysis value. | | SRCSEQ | Source Sequence Number | integer |
| Predecessor: Set to the SDTM domain sequence number that relates to the analysis value, CV.CVSEQ or LB.LBSEQ. |
|
In this example, variables BASE, CHG, PCHG, and CHGCAT1 were added to facilitate analyses of the efficacy endpoints. the variables SRCDOM, SRCVAR, and SRCSEQ provide traceability to the combined source datasets. The tables below represent parameter value level lists for applicable variables.
| Definexmltable |
|---|
| Dataset | ADEFNTP |
|---|
| Example | true |
|---|
| Level | Codelist |
|---|
| Purpose | Analysis |
|---|
| OID | PARAM.ADEFNTP |
|---|
| Name | Parameter |
|---|
|
| Permitted Value (code) |
|---|
Left Ventricular Ejection Fraction, Cal (%) | | Right Ventricular Ejection Fraction, Cal (%) | | N-Terminal ProB-type Natriuretic Peptide (ng/L) |
|
| Definexmltable |
|---|
| Dataset | ADEFNTP |
|---|
| Example | true |
|---|
| Level | Codelist |
|---|
| Purpose | Analysis |
|---|
| OID | PARAMCD.ADEFNTP |
|---|
| Name | Parameter Code |
|---|
|
| Permitted Value (code) | Display Value (Decode) |
|---|
LVEF_C | Left Ventricular Ejection Fraction, Cal (%) | | RVEF_C | Right Ventricular Ejection Fraction, Cal (%) | | BNPPRONT | N-Terminal ProB-type Natriuretic Peptide (ng/L) |
|
| Definexmltable |
|---|
| Dataset | ADEFNTP |
|---|
| Level | Value |
|---|
| Purpose | Analysis |
|---|
| Name | AVAL |
|---|
|
| Variable | Where | Type | Controlled Terms or Format | Origin | Derivation/Comment |
|---|
| AVAL | CV.CVSTRESN in ("LVEF_C", "RVEF_C") | float |
| Predecessor | CV.CVSTRESN | | AVAL | LB.LBTESTCD = "BNPPRONT" | float |
| Predecessor | LB.LBSTRESN |
|
In this table the ADaM parameters are used rather than the source SDTM data.
| Definexmltable |
|---|
| Dataset | ADEFNTP |
|---|
| Level | Value |
|---|
| Purpose | Analysis |
|---|
| Name | CHGCAT1 |
|---|
|
| Variable | Where | Type | Controlled Terms or Format | Origin | Derivation/Comment |
|---|
| CHGCAT1 | PARAMCD in ("LVEF_C", "RVEF_C") | text | Decline >=-5.0%; Decline <-5.0%; No Decline | Derived | Categorize the value of CHG as follows: If CHG >= 5.00 THEN CHGCAT1 = "Decline >=-5.0%". | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-9 |
|---|
|
Else if CHG GT 0 and CHG < 5.00 THEN CHGCAT1 = "Decline <-5.0%" Else if CHG <0 then CHGCAT1 = "No Decline" | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-10 |
|---|
|
| | CHGCAT1 | PARAMCD = "BNPPRONT" | text | Increase >100 ng/L; Increase <=100 ng/L; No Increase | Derived | Categorize the value of CHCAT1 as follows: "Increase >100 ng/L"; "Increase <=100 ng/L"; "No Increase" | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-11 |
|---|
|
|
|
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| | Row | STUDYID | USUBJID | AAGE | AGEU | SEX | RACE | TRT01P | TRT01A | ITTFL | HEIGHT | WEIGHT | BSA | ACEINHFL | PARAM | PARAMCD | PARAMN | AVAL | AVISIT | AVISITN |
|---|
|
|
| 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 wrap |
|---|
|
| Rowcaps |
|---|
| Rows 1-8: | Show the baseline CMR ejection fraction measurements for participant 101 at Screening. | | Rows 9-16: | Show the CMR ejection fraction measurements for participant 101 at VISIT 6. | | Dataset2 |
|---|
| | Row | STUDYID | USUBJID | PARAMCD | PARAM | AVAL | CVMETHOD | VISITNUMCHGCAT| CHGCAT1 | SRCDOM | SRCVAR | SRCSEQ |
|---|
| 1 | DMD- |
EFLGE101 | | EFLGE | DMD-EF-01-101 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 119 | 20 | 0.82 | Y |
LVEF_C | Left Ventricular Ejection Fraction, |
Calculated CARDIAC MAGNETIC RESONANCE IMAGINGSCREENINGY | 67 | | Y | 67 |
|
|
| CV | CVTESTCD| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-13 |
|---|
|
|
CVLVCO | LV Cardiac Output (L/min) | 5.4 | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2022-05-16 | Y | 5.4 | CV | 4 | | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 119 | 20 | 0.82 | Y |
3 | DMD-EFLGE | 101 | RVEF_C | Right Ventricular Ejection Fraction, |
Calculated 74 | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2022-05-16 | Y | 74 | CV | 7 | 4 | DMD-EFLGE | 101 | RVCO | RV Cardiac Output (L/min) | 5.6 | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | RVEF_C | 2 | 74 | Visit 1 (Baseline) | 1 | VISIT 1 |
SCREENING6785 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 119 | 20 | 0.82 | Y |
BNPPRONT | N-Terminal ProB-type Natriuretic |
Peptide (pg/mL| Peptide (ng/L) | BNPPRONT | 3 | 40 | Visit 1 (Baseline) | 1 |
SCREENING| VISIT 1 | 2022-05-16 | Y | 40 |
|
|
| LB | LBTESTCD | 1 |
6 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 132 | 32 | 1.08 | Y |
LVEF_C | Left Ventricular Ejection Fraction, |
Calculated (%)CARDIAC MAGNETIC RESONANCE IMAGING| Visit 6 (1 Year) | 6 | VISIT 6 | 2023- |
0601Y | 5.4 | CV | 11 | DMDEFLGE101 | LVCO | LV Cardiac Output (L/min) | 4.0 | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-06-01 | Y | 74 | CV | 12 | | 10.447761 | Decline >=-5.0% | CV | CVTESTCD | 11 | | 5 | DMD-EFLGE | DMD-EF-01-101 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 132 | 32 | 1.08 | Y |
8 | DMD-EFLGE | 101 | RVEF_C | Right Ventricular Ejection Fraction, |
Calculated CARDIAC MAGNETIC RESONANCE IMAGING| Visit 6 (1 Year) | 6 | VISIT 6 | 2023 |
-06-01Y | | -04-23 |
| 74 | -13 | -17.567568 | Decline >=-5.0% | CV | CVTESTCD |
CV9101 | RVCO | RV Cardiac Output (L/min) | 4.0 | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-06-01 | Y | CV | 16 | | DMD-EF-01-101 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 132 | 32 | 1.08 | Y |
10 | DMD-EFLGE | 101 | BNPPRONT | N-Terminal ProB-type Natriuretic Peptide ( |
pgmL6VISIT 6 | 2023-06-01 | Y | LB | 2 | |
|
(Copied from the SDTM page for reference until I create the sample ADaM dataset
| 3 | 900 | Visit 6 (1 Year) | 6 | VISIT 6 | 2023-04-23 |
| 40 | 860 | 2,150 | Increase >100 ng/L | LB | LBTESTCD | 2 |
|
|
ADEFMRI
The ADEFMRI is an efficacy analysis dataset with only a few records for more complex modeling of changes in ejection fraction, plus the proB-type test results. It is an ADaM Basic Data Structure (BDS) dataset| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-15 |
|---|
|
, with additional variables added from ADEFNTP dataset.
The dataset can can be used for analyses with multiple covariates
| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-14 |
|---|
|
by taking the lab tests of interest (PARAMCD = "BNPPRONT") or other analysis datasets, and merging variables of interest with the ADEFNTP dataset. This summary dataset is created from other ADaM datasets and only variables used in the analysis are kept.| Definexmltable |
|---|
| Dataset | ADEFMRI |
|---|
| Level | Variable |
|---|
| Purpose | Analysis |
|---|
| Name | Variable |
|---|
|
| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Source/Derivation/Comment |
|---|
| STUDYID | Study Identifier | text |
| Predecessor: ADEFNTP.STUDYID | | USUBJID | Unique Subject Identifier | text |
| Predecessor: ADEFNTP.USUBJID | | BRTHDT | Date of Birth | integer | yymmdd10. | Predecessor: ADEFNTP.BRTHDT | | AAGE | Analysis Age | float |
| Predecessor: ADEFNTP.AAGE | | AGEU | Age Unit | text | YEARS | Predecessor: ADEFNTP.AGEU | SEX | Sex | text | (SEX) | Predecessor: ADEFNTP.SEX | RACE | Race | text | (RACE) | Predecessor: ADEFNTP.RACE | | TRTSDT | Date of First Exposure to Treatment | Num | yymmdd10. | Predecessor: ADEFNTP.TRTSDT | | TRT01P | Planned Treatment for Period 01 | text | Drug A; Drug B | Predecessor: ADEFNTP.TRT01P | ITTFL | Intent-To-Treat Population Flag | text | Y; N | Predecessor: ADEFNTP.ITTFL | | BSA | Body Surface Area (m2) | float |
| Predecessor: ADEFNTP.BSA | ACEINHFL | ACE Inhibitor Medications Flag | text | Y; N | Predecessor: ADEFNTP.ACEINHFL | BNPPRONT |
| integer |
| Derived: BNPPRONT = AVAL where PARAMCD = ADEFNTP.BNPPRONT, and merge by USUBJID and AVISITN. Note: There are many ways to add this including transposing the data. | | PARAM | Parameter | text | Left Ventricular Ejection Fraction, Cal (%); Right Ventricular Ejection Fraction, Cal (%) | Predecessor: ADEFNTP.PARAM | | PARAMCD | Parameter Code | text | LVEF_C; RVEF_C | Predecessor: ADEFNTP.PARAMCD | | PARAMN | Parameter (N) | integer |
| Predecessor: ADEFNTP.PARAMN | | AVAL | Analysis Value | float |
| Predecessor: ADEFNTP.AVAL | | AVISIT | Analysis Visit | text | Visit 1 (Baseline); Visit 6 (1 Year) | Predecessor: ADEFNTP.AVISIT | | AVISITN | Analysis Visit (N) | integer | 1; 6 | Predecessor: ADEFNTP.AVISITN | | ADT | Analysis Date | float | yymmdd10. | Predecessor: ADEFNTP.ADT | | ABLFL | Baseline Record Flag | text | Y | Predecessor: ADEFNTP.ABLFL | | BASE | Baseline Value | float |
| Predecessor: ADEFNTP.BASE | | CHG | Change from Baseline | float |
| Predecessor: ADEFNTP.CHG | | PCHG | Percent Change from Baseline | float |
| Predecessor: ADEFNTP.PCHG | | CHGCAT1 | Change from Baseline Category 1 | text | Decline >=5.0%; Decline <-5.0%; Increase >100 ng/L | Predecessor: ADEFNTP.CHGCAT1 |
|
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| | Row | STUDYID | USUBJID | BRTHDT | TRT01P | AAGE | AGU | SEX | RACE | TRT01A | ITTFL | BSA | ACEINHFL | BNPPRONT | PARAM | PARAMCD | PARAMN | AVAL | AVISIT | AVISITN | ADT | ABLFL | BASE | CHG | PCHG | CHGCAT1 |
|---|
| 1 | DMD-EFLGE | DMD-EF-01-101 | 2010-02-07 | Drug A | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Y | 0.82 | Y | 40 | Left Ventricular Ejection Fraction, Cal (%) | LVEF_C | 1 | 70 | Visit 1 (Baseline) | 1 | 2022-05-16 | Y | 70 |
|
|
| | 2 | DMD-EFLGE | DMD-EF-01-101 | 2010-02-07 | Drug A | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Y | 0.82 | Y | 40 | Right Ventricular Ejection Fraction, Cal (%) | RVEF_C | 2 | 75 | Visit 1 (Baseline) | 1 | 2022-05-16 | Y | 75 |
|
|
| | 3 | DMD-EFLGE | DMD-EF-01-101 | 2010-02-07 | Drug A | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Y | 1.08 | Y | 900 | Left Ventricular Ejection Fraction, Cal (%) | LVEF_C | 1 | 65 | Visit 6 (1 Year) | 6 | 2023-04-23 |
| 70 | -5 | -10.447761 | Decline >==5.0% | | 4 | DMD-EFLGE | DMD-EF-01-101 | 2010-02-07 | Drug A | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Y | 1.08 | Y | 900 | Right Ventricular Ejection Fraction, Cal (%) | RVEF_C | 2 | 70 | Visit 6 (1 Year) | 6 | 2023-04-23 |
| 75 | -5 | -17.567568 | Decline >==5.0% |
|
|
| Dataset wrap |
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| Rowcaps |
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| Rows 1-8: | Show the baseline CMR ejection fraction measurements for participant 101 at Screening. |
| Rows 9-16: | Show the CMR ejection fraction measurements for participant 101 at VISIT 6. |
| Dataset2 |
|---|
|
| Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVLNKID | CVTESTCD | CVTEST | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVMETHOD | VISITNUM | VISIT | CVDTC | CVDY |
|---|
1 | DMD-EFLGE | CV | 101 | 1 | LVESV | Left Ventricle End Systolic Volume | 32 | mL | 32 | 32 | mL | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2022-05-16 | 2 | DMD-EFLGE | CV | 101 | 2 | LVEDV | Left Ventricle End Diastolic Volume | 95 | mL | 95 | 95 | mL | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2022-05-16 | 3 | DMD-EFLGE | CV | 101 | 3 | 2 | LVEF_C | Left Ventricular Ejection Fraction, Calculated | 67 | % | 67 | 67 | % | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2022-05-16 | 4 | DMD-EFLGE | CV | 101 | 4 | 2 | LVCO | LV Cardiac Output | 5.4 | L/min | 5.4 | 5.4 | L/min | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2022-05-16 | 5 | DMD-EFLGE | CV | 101 | 5 | RVESV | Right Ventricle End Systolic Volume | 24 | mL | 24 | 24 | mL | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2022-05-16 | 6 | DMD-EFLGE | CV | 101 | 6 | RVEDV | Right Ventricle End Diastolic Volume | 90 | mL | 90 | 90 | mL | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2022-05-16 | 7 | DMD-EFLGE | CV | 101 | 7 | 2 | RVEF_C | Right Ventricular Ejection Fraction, Calculated | 74 | % | 74 | 74 | % | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2022-05-16 | 8 | DMD-EFLGE | CV | 101 | 8 | 2 | RVCO | RV Cardiac Output | 5.6 | L/min | 5.6 | 5.6 | L/min | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2022-05-16 | 9 | DMD-EFLGE | CV | 101 | 9 | LVESV | Left Ventricle End Systolic Volume | 37 | mL | 37 | 37 | mL | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-06-01 | 376 | 10 | DMD-EFLGE | CV | 101 | 10 | LVEDV | Left Ventricle End Diastolic Volume | 94 | mL | 94 | 94 | mL | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-06-01 | 376 | | 11 | DMD-EFLGE | CV | 101 | 11 | 2 | LVEF_C | Left Ventricular Ejection Fraction, Calculated | 60 | % | 60 | 60 | % | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-06-01 | 376 |
| 12 | DMD-EFLGE | CV | 101 | 12 | 2 | LVCO | LV Cardiac Output | 4.0 | L/min | 4.0 | 4.0 | L/min | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-06-01 | 376 |
13 | DMD-EFLGE | CV | 101 | 13 | RVESV | Right Ventricle End Systolic Volume | 36 | mL | 36 | 36 | mL | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-06-01 | 376 | 14 | DMD-EFLGE | CV | 101 | 14 | RVEDV | Right Ventricle End Diastolic Volume | 93 | mL | 93 | 93 | mL | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-06-01 | 376 | | 15 | DMD-EFLGE | CV | 101 | 15 | 2 | RVEF_C | Right Ventricular Ejection Fraction, Calculated | 61 | % | 61 | 61 | % | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-06-01 | 376 |
| 16 | DMD-EFLGE | CV | 101 | 16 | 2 | RVCO | RV Cardiac Output | 4.0 | L/min | 4.0 | 4.0 | L/min | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-06-01 | 376 |
| Info |
|---|
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 |