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- Left Ventricular Ejection Fraction, Calculated (%)
- Right Ventricular Ejection Fraction, Calculated (%)
- N-Terminal ProB-type Natriuretic Peptide (pg/mL)
| Dataset wrap |
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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 | HEIGHTV | WEIGHTV | BSA | ACEINHFL | 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 | 119 | 20 | 1.09 | Y | 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 | 119 | 20 | 1.09 | 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 | 119 | 20 | 1.09 | 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 | 132 | 32 | 1.33 | 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 | 132 | 32 | 1.33 | 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 | 132 | 32 | 1.33 | 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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ADCVCMR Analysis Dataset
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. The stratification variables such as BSA and ACEINHFL are carried over, but not HEIGHTW or WEIGHTW which were used to compute BSA values.
| Definexmltable |
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| Dataset | ADCVCMR |
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| Level | Value |
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| Purpose | Analysis |
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| OID | AVAL |
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| Dataset | Value | Where | Variable | Variable Label |
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| ADCVCMR | AVAL | PARAMCD = "BNPPRONT" | BNPPRONT | N-Terminal ProB-type Natriuretic Peptide (IU/L) | | ADCVCMR | CHG | PARAMCD = "BNPPRONT" | BNPCHG | N-Term ProB-type N Pep Change Category |
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| Dataset wrap |
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| Name | adcvcmr |
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| Dataset2 |
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| Row | STUDYID | USUBJID | ASEQ | BRTHDT | TRT01P | ITTFL | BSA | ACEINHFL | 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 | 1.09 | 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 | 1.09 | 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 | 1.33 | Y | 900 | 2150 | Left Ventricular Ejection Fraction, Calculated (%) | LVEFC | 1 | 60 | Visit 6 (1 Year) | 6 | VISIT 6 | 06APR2023 |
| 67 | -7 | -10.447761 | CV | 11 | | 4 | DMD-EFLGE | DMD-EFLGE-101 | 4 | 15FEB2013 | Treatment A | Y | 1.33 | Y | 900 | 2150 | Right Ventricular Ejection Fraction, Calculated (%) | RVEFC | 2 | 61 | Visit 6 (1 Year) | 6 | VISIT 6 | 06APR2023 |
| 74 | -13 | -17.567568 | CV | 15 |
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Example Analysis Results Metadata (ARM) Tables
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