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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 | USUBJID | ADaMIG v1.3 section 3.1.1 | | ADCEFADCVNTRP | Cardiac Ejection Fraction Fraction and NTproBNP Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter. | adcvef.xpt | USUBJID, AVISITN, PARAMCD | | ADLBNTRP | Cardiac NTproBNP Laboratory Analysis BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter. | | adntpro.xpt | 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 | |
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| Definexmltable |
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| Multiple | true |
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| Dataset | ADCEF, ADLBNTRPADCVNTRP |
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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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| ADCEFADCVNTRP | AVAL | PARAMCD = " LVEFC" | Num | Predecessor | Set to CV. CVSTRESN where CV.CVTESTCD ="LVEF_C". | | ADCEFADCVNTRP | AVAL | PARAMCD = "RVEFC" | Num | Predecessor | Set to CV. CVSTRESN where CV.CVTESTCD ="RVEF_C". | | ADLBNTRP | AVAL | PARAMCD = "BNPPRONT" | Num | Predecessor | Set to LB.LBSTRESN where LB.LBTESTCD = "BNPPRONT" |
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The following are the data structures for the example ADaM datasetdatasets. Note that the columns for derived variables, BASE, and CHG, PCHG and CHGCAT1 have been added for the efficacy analysis of endpoints. The example demographics for ADSL were created for a xx an 8 year old male child. The ADaM standard only suggests variable order, so the demographics and treatment variables have been put at the end, so that the variables of interest are shown at the beginning of the dataset. Since we are combining two SDTM domains into one analysis dataset, some variables unique to LB will be blank for records from CV.
| Definexmltable |
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| Dataset | ADCV |
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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 |
.| TRT01P | Planned Treatment for Period 01 | Char | "Treatment A" | ADSL.TRT01P | For this example we are putting "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 | Pick other population? POSSIBLE RWE STUDY | AGE | Age | Num | ADSL.AGE | AGEU | Age Units | Char | (AGEU) | ADSL.AGEU | SEX | Sex | Char | (SEX) | ADSLSEX | | BSABASE | Body Surface Area (m2) at Baseline | Num |
| ADSL.BSABSE | 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. | | 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 |
1, 6 |
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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 |
|
| Set BASE to AVAL from the record for that subject and parameter where ABLFL = "Y". Populate BASE for additional |
visit USUJID USUBJID and ADT. (Or by AVISIT if ADT varies for labs, and 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 |
| >1.0 g/dL; <=1.0 g/dL |
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| | LBSTRNRLO | Reference Range Lower Limit-Std Units |
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| LB.LBSTRNRLO |
| | LBSTRNHI | Reference Range Upper Limit-Std Units |
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| LB.LBSTRNHI |
| | LBNRIND | Reference Range
Indicator |
| (NRIND) | LB.LBNRIND |
| | 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 | Pick other population? POSSIBLE RWE STUDY | | 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. |
LBSTRNRLO | LBSTRNHI | LBNRIND | | 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 - Systolic Function |
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