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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 | 15FEB202115FEB2013 | 16MAY202215FEB2022 | Treatment A | Y | 0.65 | Y |
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| 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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| 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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| 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 | 15FEB202115FEB2013 | 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 | 15FEB202115FEB2013 | 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 | 15FEB202115FEB2013 | 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 | 15FEB202115FEB2013 | Treatment A | Y | 0.65 | Y |
| Left Ventricular Ejection Fraction, Calculated (%) | LVEFC | 1 | 60 | Visit 6 (1 Year) | 6 | VISIT 6 | 01JUN202306APR2023 |
| 67 | -7 | -10.447761 | Decline >=10.0 | CV | 11 | | 5 | DMD-EFLGE | DMD-EFLGE-101 | 5 | 15FEB202115FEB2013 | Treatment A | Y | 0.65 | Y |
| Right Ventricular Ejection Fraction, Calculated (%) | RVEFC | 2 | 61 | Visit 6 (1 Year) | 6 | VISIT 6 | 01JUN202306APR2023 |
| 74 | -13 | -17.567568 | Decline >=10.0 | CV | 15 | | 6 | DMD-EFLGE | DMD-EFLGE-101 | 6 | 15FEB202115FEB2013 | Treatment A | Y | 0.65 | Y |
| N-Terminal ProB-type Natriuretic Peptide (IU/L) | BNPPRONT | 3 | 900 | Visit 6 (1 Year) | 6 | VISIT 1 | 01JUN202306APR2023 |
| 40 | 860 | 2,150 |
| LB | 2 |
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Example 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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| Dataset2 |
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| | Row | STUDYID | USUBJID | ASEQ | BRTHDT | TRT01P | ITTFL | BSABASE | ACEINHFL | BSA | BNPPRONT | BNPCHG | PARAM | PARAMCD | PARAMN | AVAL | AVISIT | AVISITN | VISIT | ADT | ABLFL | BASE | CHG | PCHG | SRCDOM | SRCSEQ |
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| 1 | DMD-EFLGE | DMD-EFLGE-101 | 1 | 15FEB2013 | Treatment A | Y | 0.65 | Y |
| 40 |
| 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 |
| 40 |
| 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 |
| 900 | 2150 | Left Ventricular Ejection Fraction, Calculated (%) | LVEFC | 1 | 60 | Visit 6 (1 Year) | 6 | VISIT 6 |
01JUN2023| 06APR2023 |
| 67 | -7 | -10.447761 | CV | 11 | | 4 | DMD-EFLGE | DMD-EFLGE-101 | 4 | 15FEB2013 | Treatment A | Y | 0.65 | Y |
| 900 | 2150 | Right Ventricular Ejection Fraction, Calculated (%) | RVEFC | 2 | 61 | Visit 6 (1 Year) | 6 | VISIT 6 |
01JUN2023| 06APR2023 |
| 74 | -13 | -17.567568 | CV | 15 |
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Example Analysis Results Metadata (ARM) Tables
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