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The analysis datasets for this example include treatment and demographic information drawn from the Subject Level Analysis Dataset (ADSL), defined in the Metadata Tables below. Only some of the required variables from ADSL are shown for illustrative purposes. The ADSL incorporates demographics, treatment groups, study dates, and stratification variables. Additional information on the ADSL can be found in Section 2.3.1 of the ADaM Implementation Guide (ADaMIG) v1.3.
The ADSL is combined with other SDTM dataset to create the analysis datasets. More than one SDTM dataset can be combined in this way. Also, stratification variables can be created in the ADSL to subset by, or to add variables needed in the analyses. For instance, stratification variable might be type of concomitant medications, such as an ACE inhibitors. for this we added a flag ACEMEDFL, which is coded Y or N. Another variable added; body surface area (BSABL), is derived from the LB dataset at the baseline visit and added to ADSL. However, when the subjects are children, the body surface area changes over time. Therefore, an additional non-standard variable is added to the analysis dataset with the subject's current BSA by visit.
The ADCVNTP dataset includes tests pertinent to these analyses. The record LB are selected where CVTESTCD is equal to "LVEF_C" or "RVEF_C". It also includes a subset of the Laboratory Results (LB) SDTM dataset, for which LBTESTCD is equal to "BNPPRONT". The relationship dataset RELREC illustrates the relationship between datasets. In this case, many lab draws may occur throughout the year, but only those linked to a specific visit are included. By subsetting the LB dataset with 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, a windowing strategy could be used to select the laboratory draw closest to that visit for merging with CV, computed in AVISIT. In the example, only two LB records are shown which are linked to CV where CVTESTCD = "LVEF_C" or CVTESTCD = "R.VEF_C"
ADCVMR 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, with additional variables added from ADCVNTP.
The tableS tables below showsthe show the example analysis dataset metadata and parameters used for the analysis.
| 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 | One record per subject | adsl.xpt | USUBJID | ADaMIG | | ADCVNTP | Cardiac Ejection Fraction and NTproBNP Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter | adcvntp.xpt | USUBJID, AVISITN, PARAMN | | | ADCVCMR | Cardiovascular CMR Ejection Fraction Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter | adcvcmr.xpt | USUBJID, AVISITN, PARAMN | |
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| Definexmltable |
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| Dataset | ADSL |
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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 |
| DM.STUDYID |
| | USUBJID | Unique Subject Identifier | Char |
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| | BRTHDT | Date of Birth | Num | date9. | ADSL.BRTHDTC | Convert BRTHDTC from ISO 8601 format to numeric date. (Note that if exact date is not found then use two variables to capture year and month.) | | TRTSDT | Date of First Exposure to Treatment | Num | date9. |
| Date portion of DM.RFSTDTC converted to numeric and displayed in a format such as DATE9. | | 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 | Derive the intent-to-treat population as per the protocol and SAP. | | BSABASE | Body Surface Area (m2) at Baseline | Num |
| ADSL.BSABASE | Set to VS.VSSTRESN in ADSL where VS.VSTESTCD = "BSA" and select for baseline visit. | ACEINHFL | ACE Inhibitor Medications Flag | Char | Y |
| Select a list of ACE inhibitor medications from concomitant medications (CM) domain, and from treatment (EX or EC) domains. Code "Y" if the medication was taken during the study. Can be used to subset or to exclude the population who took ACE inhibitors. |
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| Dataset2 |
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| | Row | STUDYID | USUBJID | BRTHDT | TRTSDT | TRT01P | ITTFL | BSABASE | ACENHFL |
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| 1 | DMD-EFLGE | DMD-EFLGE-101 | 15FEB2013 | 15FEB2022 | Treatment A | Y | 0.65 | Y |
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| Definexmltable |
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Dataset |
ADCVNTP
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Analysis Dataset
The subsequent section provides the data structures for the example ADaM datasets. In this example, columns for derived variables BASE, CHG, PCHG and CHGCAT1 have been added to facilitate analyses of the efficacy endpoints. Specifically, example demographic data for ADSL were created for an 8 year old male. Also, a custom variable for BSA at baseline (BSABASE), and an example of a stratification variable for subjects with was added from ADSL.
| 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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| 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" |
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| ADCVNTP | AVAL | PARAMCD = "RVEFCLVEFC" | Num | Predecessor | Set to CV.CVSTRESN where CV.CVTESTCD = "RVEFLVEF_C" | | ADCVNTP | AVAL | PARAMCD = "BNPPRONTRVEFC" | Num | Predecessor | Set to LBCV.LBSTRESN CVSTRESN where LBCV.LBTESTCD CVTESTCD = "BNPPRONTRVEF_C" |
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Analysis Datasets for Ejection Fraction
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| | 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. | | BRTHDT | Date of Birth | Num | Date9. | ADSL.BRTHDTC | Convert BRTHDTC from ISO 8601 format to numeric date. (Note that if exact date is not found then use two variables to capture year and month.) | | TRT01P | Planned Treatment for Period 01 | Char | Treatment A | ADSL.TRT01P |
| ITTFL | Intent-To-Treat Population Flag | Char | Y; N | ADSL.ITTFL | | | BSABASE | Body Surface Area (m2) at Baseline | Num |
| ADSL.BSABASE | Compute in ADSL where VS.VSTESTCD = "BSA". | ACEINHFL | ACE Inhibitor Medications Flag | Char | Y |
| Select a list of ACE inhibitor medications from concomitant medications (CM) domain, and from treatment (EX or EC) domains. Code "Y" if the medication was taken during the study. Can be used to subset or to exclude the population who took ACE inhibitors. | | BSA | Body Surface Area (m2) by Visit | Num |
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| Compute from VS.HEIGHT and VS.WEIGHT by visit, using the Du Bois method. Note that there are multiple methods to compute, and the study protocol should describe which one to use. (e.g. other methods may be Mosteller, Haycock, Gehan & George, Boyd, Fujimoto, Takahira, and Schlich) | | 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 (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 carrying forward the value of BASE in the baseline record by USUBJID and AVISIT. | | 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) | | 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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Example 1
This example dataset shows the findings and additional analysis variables associated with:
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| Rowcaps |
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| Rows 1-2: | Show the baseline ejection fraction measurements at VISIT 1. | | Row 3: | Shows the baseline N-Terminal ProB-type Natriuretic Peptide test results at VISIT 1. | | Rows 4-5: | Show the baseline ejection fraction measurements at VISIT 6. | | Row 6: | Shows the baseline N-Terminal ProB-type Natriuretic Peptide test results at VISIT 6. |
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| Dataset2 |
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| | Row | STUDYID | USUBJID | ASEQ | BRTHDT | TRT01P | ITTFL | BSABASE | ACEINHFL | BSA | PARAM | PARAMCD | PARAMN | AVAL | AVISIT | AVISITN | VISIT | ADT | ABLFL | BASE | CHG | PCHG | CHGCAT1 | SRCDOM | SRCSEQ |
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| 1 | DMD-EFLGE | DMD-EFLGE-101 | 1 | 15FEB2013 | Treatment A | Y | 0.65 | Y | 0.65 | Left Ventricular Ejection Fraction, Calculated (%) | LVEFC | 1 | 67 | Visit 1 (Baseline) | 1 | VISIT 1 | 16MAY2022 | Y | 67 |
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| CV | 3 | | 2 | DMD-EFLGE | DMD-EFLGE-101 | 2 | 15FEB2013 | Treatment A | Y | 0.65 | Y |
| Right Ventricular Ejection Fraction, Calculated (%) | RVEFC | 2 | 74 | Visit 1 (Baseline)) | 1 | VISIT 1 | 16MAY2022 | Y | 74 |
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| CV | 7 | | 3 | DMD-EFLGE | DMD-EFLGE-101 | 3 | 15FEB2013 | Treatment A | Y | 0.65 | Y |
| N-Terminal ProB-type Natriuretic Peptide (IU/L) | BNPPRONT | 3 | 40 | Visit 1 (Baseline) | 1 | VISIT 1 | 16MAY2022 | Y | 40 |
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| LB | 1 | | 4 | DMD-EFLGE | DMD-EFLGE-101 | 4 | 15FEB2013 | Treatment A | Y | 0.65 | Y |
| Left Ventricular Ejection Fraction, Calculated (%) | LVEFC | 1 | 60 | Visit 6 (1 Year) | 6 | VISIT 6 | 06APR2023 |
| 67 | -7 | -10.447761 | Decline >=10.0 | CV | 11 | | 5 | DMD-EFLGE | DMD-EFLGE-101 | 5 | 15FEB2013 | Treatment A | Y | 0.65 | Y |
| Right Ventricular Ejection Fraction, Calculated (%) | RVEFC | 2 | 61 | Visit 6 (1 Year) | 6 | VISIT 6 | 06APR2023 |
| 74 | -13 | -17.567568 | Decline >=10.0 | CV | 15 | | 6 | DMD-EFLGE | DMD-EFLGE-101 | 6 | 15FEB2013 | Treatment A | Y | 0.65 | Y |
| N-Terminal ProB-type Natriuretic Peptide (IU/L) | BNPPRONT | 3 | 900 | Visit 6 (1 Year) | 6 | VISIT 1 | 06APR2023 |
| 40 | 860 | 2,150 |
| LB | 2 |
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ADCVNTP Analysis Dataset
Placeholder
Example 2 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 ADCVNTP dataset. In that case, the records from LB are not needed as a row.
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