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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 | | ADCVNTRPADCVNTP | 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 | ADCVNTRP |
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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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| ADCVNTRPADCVNTP | AVAL | PARAMCD = " LVEFC" | Num | Predecessor | Set to CV. CVSTRESN where CV.CVTESTCD ="LVEF_C". | | ADCVNTRPADCVNTP | AVAL | PARAMCD = "RVEFC" | Num | Predecessor | Set to CV. CVSTRESN where CV.CVTESTCD ="RVEF_C". | | ADCVNTRPADCVNTP | AVAL | PARAMCD = "BNPPRONT" | Num | Predecessor | Set to LB.LBSTRESN where LB.LBTESTCD = "BNPPRONT" |
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The dataset above can also be set up to provide multivariate analyses by taking the lab tests of interest, transposing and merging with the ADCVNTPR ADCVNTPP dataset. In that case, the records from LB are not needed as a row.
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| Dataset | Value | Where | Variable | Variable Label |
|---|
| ADCVNTPRADCVNTP | AVAL | PARAMCD ="BNPPRONT" | BNPPRONT | N-Terminal ProB-type Natriuretic Peptide (IU/L) |
| ADCVNTPRADCVNTP | CHGCAT1 | PARAMCD ="BNPPRONT" | BNPPRCHG | N-Term ProB-type N Pep Change Category |
| Dataset wrap |
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| Dataset2 |
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| | Row | STUDYID | USUBJID | ASEQ | BSABASE | BNPPRONT | BNPPRCHG | PARAM | PARAMCD | PARAMN | AVAL | AVISIT | AVISITN | VISIT | ADT | ABLFL | BASE | CHG | PCHG | TRT01P | ITTFL | AGE | AGEU | SEX | SRCDOM | SRCSEQ |
|---|
| 1 | DMD-EFLGE | DMD-EFLGE-101 | 1 | 0.65 | 40 |
| Left Ventricular Ejection Fraction, Calculated (%) | LVEFC | 1 | 67 | Visit 1 (Month 1) | 1 | VISIT 1 | 16May2022 | Y | 67 |
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| Treatment A | Y | 8 | YEARS | M | CV | 3 | | 2 | DMD-EFLGE | DMD-EFLGE-101 | 2 | 0.65 | 40 |
| Right Ventricular Ejection Fraction, Calculated (%) | RVEFC | 2 | 74 | Visit 1 (Month 1) | 1 | VISIT 1 | 16May2022 | Y | 74 |
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| Treatment A | Y | 8 | YEARS | M | CV | 7 | | 3 | DMD-EFLGE | DMD-EFLGE-101 | 3 | 0.65 | 900 | >1.0 (IU/L) | Left Ventricular Ejection Fraction, Calculated (%) | LVEFC | 1 | 60 | Visit 6 (Month 12) | 6 | VISIT 6 | 01Jun2023 |
| 67 | -7 | -10.447761 | Treatment A | Y | 8 | YEARS | M | CV | 11 | | 4 | DMD-EFLGE | DMD-EFLGE-101 | 4 | 0.65 | 900 | >1.0 (IU/L) | Right Ventricular Ejection Fraction, Calculated (%) | RVEFC | 2 | 61 | Visit 6 (Month 12) | 6 | VISIT 6 | 01Jun2023 |
| 74 | -13 | -17.567568 | Treatment A | Y | 8 | YEARS | M | CV | 15 |
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