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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 | | ADCVNTP | Cardiac Ejection Fraction and NTproBNP Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter. | adcvntrp.xpt | USUBJID, AVISITN, PARAMN | | | ADCMRI | Cardiac Magnetic Resonance Imaging Measurements Summary Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter. | adcmrief.xpt | USUBJID, AVISITN, PARAMN | |
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| Definexmltable |
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| Dataset | ADCVNTRPADCVNTP |
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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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| ADCVNTP | AVAL | PARAMCD = " LVEFC" | Num | Predecessor | Set to CV. CVSTRESN where CV.CVTESTCD ="LVEF_C". | | ADCVNTP | AVAL | PARAMCD = "RVEFC" | Num | Predecessor | Set to CV. CVSTRESN where CV.CVTESTCD ="RVEF_C". | | ADCVNTP | AVAL | PARAMCD = "BNPPRONT" | Num | Predecessor | Set to LB.LBSTRESN where LB.LBTESTCD = "BNPPRONT" |
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The subsequent section outlines the data structures for the example ADaM datasets. In this example, columns for derived variables BASE, and CHG, PCHG and CHGCAT1 have been added fto facilitate analyses of efficacy endpoints. Specifically, example demographic data for ADSL were created for an 8 year old male child. Also, BSA at baseline (BSABASE), an example of a custom variable, was added from ADSL. The ADaM standard only suggests variable order, so the demographics and treatment variables are shown at the right of the dataset.
| Definexmltable |
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| Dataset | ADCVADCVNTP |
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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. | | 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
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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. | | PARAMN | Parameter Number | Num |
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| Number PARAMCD as follows: "LVEFC = 1" "LVRFC = 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 merging by 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 |
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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 | >1.0 (IU/L); <=1.0 (IU/L) |
| Categorise the value of CHG | | LBSTRNRLO | Reference Range Lower Limit-Std Units | Num |
| LB.LBSTRNRLO |
| | LBSTRNHI | Reference Range Upper Limit-Std Units | Num |
| LB.LBSTRNHI |
| | LBNRIND | Reference Range
Indicator | Char | (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. | | 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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