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| 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 | AGE | AGEU | SEX | RACE | TRT01P | TRT01A | ITTFL | BSASC | HEIGHT | WEIGHT | BSA | ACEINHFL | PARAM | PARAMCD | PARAMN | AVAL | AVISIT | AVISITN | VISIT | ADT | ABLFL | BASE | CHG | PCHG | CHGCAT1 | SRCDOM | SRCVAR | SRCSEQ |
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| 1 | DMD-EFLGE | DMD-EF-01-101 | 12 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 0.82 | 119 | 20 | 0.82 | Y | Left Ventricular Ejection Fraction, Calculated (%) | LVEF_C | 1 | 67 | Visit 1 (Baseline) | 1 | VISIT 1 | 16MAY2022 | Y | 67 |
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| CV | CVTESTCD | 3 | | 2 | DMD-EFLGE | DMD-EF-01-101 | 12 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 0.82 | 119 | 20 | 0.82 | Y | Right Ventricular Ejection Fraction, Calculated (%) | RVEF_C | 2 | 74 | Visit 1 (Baseline)) | 1 | VISIT 1 | 16MAY2022 | Y | 74 |
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| CV | CVTESTCD | 7 | | 3 | DMD-EFLGE | DMD-EF-01-101 | 12 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 0.82 | 119 | 20 | 0.82 | 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 | LBTESTCD | 1 | | 4 | DMD-EFLGE | DMD-EF-01-101 | 12 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 0.82 | 132 | 32 | 1.08 | Y | Left Ventricular Ejection Fraction, Calculated (%) | LVEF_C | 1 | 60 | Visit 6 (1 Year) | 6 | VISIT 6 | 06APR2023 |
| 67 | -7 | -10.447761 | Decline >=5.0% | CV | CVTESTCD | 11 | | 5 | DMD-EFLGE | DMD-EF-01-101 | 12 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 0.82 | 132 | 32 | 1.08 | Y | Right Ventricular Ejection Fraction, Calculated (%) | RVEF_C | 2 | 61 | Visit 6 (1 Year) | 6 | VISIT 6 | 06APR2023 |
| 74 | -13 | -17.567568 | Decline >=5.0% | CV | CVTESTCD | 15 | | 6 | DMD-EFLGE | DMD-EF-01-101 | 12 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 0.82 | 132 | 32 | 1.08 | Y | N-Terminal ProB-type Natriuretic Peptide (IU/L) | BNPPRONT | 3 | 900 | Visit 6 (1 Year) | 6 | VISIT 1 | 06APR2023 |
| 40 | 860 | 2,150 | Increase GT 100 pg/mL | LB | LBTESTCD | 2 |
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ADCVCMR Analysis Dataset
Efficacy Example 2
The dataset above can also be set up to provide multivariate analyses by taking the lab tests of interest or other analysis datasets, and merging variables of interest with the ADCVNTP dataset. This summary dataset is created from other ADaM datasets as the source and only variable used in the analysis are kept.
| Definexmltable |
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| Dataset | ADCVCMR |
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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 |
|---|
| STUDYID | Study Identifier | Char |
| ADCVNTP.STUDYID |
| | USUBJID | Unique Subject Identifier | Char |
| |
| | BRTHDT | Date of Birth | Num | Date9. | ADCVNTP.BRTHDT |
| | AGE | Age | Num |
| ADCVNTP.AGE |
| | AGEU | Age Unit | Char | YEARS | ADCVNTPL.AGEU |
| | TRTSDT | Date of First Exposure to Treatment | Num | date9. | ADCVNTP.TRTSDT |
| | TRT01P | Planned Treatment for Period 01 | Char | Drug A; Drug B | ADCVNTP.TRT01P |
| ITTFL | Intent-To-Treat Population Flag | Char | Y; N | ADCVNTP.ITTFL | | | BSASC | Body Surface Area at Screening | Num |
| ADCVNTP.BSASC | | | BSA | Body Surface Area (m2) | Num |
| ADCVNTP.BSA |
| ACEINHFL | ACE Inhibitor Medications Flag | Char | Y; N | ADCVNTP.ACEINHFL |
| BNPPRONT |
| Num |
|
| BNPPRONT = AVAL where PARAMCD = ADCVNTP.BNPPRONT, and merge by USUBJID and AVISITN. Note: there are many ways to add this including transposing the data. | | PARAM | Parameter | Char | Left Ventricular Ejection Fraction, Calculated (%); Right Ventricular Ejection Fraction, Calculated (%); N-Terminal ProB-type Natriuretic Peptide (pg/mL) | ADCVNTP.PARAM | | | PARAMCD | Parameter Code | Char | LVEF_C; RVEF_C; BNPPRONT | ADCVNTP.PARAMCD |
| | PARAMN | Parameter (N) | Num |
| ADCVNTP.PARAMN |
| | AVAL | Analysis Value | Num |
| ADCVNTP.AVAL |
| | AVISIT | Analysis Visit | Char | Visit 1 (Baseline); Visit 6 (1 Year) | ADCVNTP.AVISIT |
| | AVISITN | Analysis Visit (N) | Num | 1; 6 | ADCVNTP.AVISITN |
| | ADT | Analysis Date | Num | date9. | ADCVNTP.ADT |
| | ABLFL | Baseline Record Flag | Char | Y | ADCVNTP.ABLFL |
| | BASE | Baseline Value | Num |
| ADCVNTP.BASE | | | CHG | Change from Baseline | Num |
| ADCVNTP.CHG |
| | PCHG | Percent Change from Baseline | Num |
| ADCVNTP.PCHG |
| | CHGCAT1 | Change from Baseline Category 1 | Char | Decline >=5% ; Decline <5% Increase GT 100 pg/mL | ADCVNTP.CHGCAT1 |
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Efficacy Analysis Example 2
| Dataset wrap |
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| Dataset2 |
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| | Row | STUDYID | USUBJID | BRTHDT | TRT01P | TRT01A | ITTFL | BSA | ACEINHFL | BNPPRONT | PARAM | PARAMCD | PARAMN | AVAL | AVISIT | AVISITN | ADT | ABLFL | BASE | CHG | PCHG | CHGCAT1 |
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| 1 | DMD-EFLGE | DMD-EF-01-101 | 07FEB2010 | Drug A | Drug A | Y | 0.82 | Y | 40 | Left Ventricular Ejection Fraction, Calculated (%) | LVEF_C | 1 | 70 | Visit 1 (Baseline) | 1 | 16MAY2022 | Y | 70 |
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| | 2 | DMD-EFLGE | DMD-EF-01-101 | 07FEB2010 | Drug A | Drug A | Y | 0.82 | Y | 40 | Right Ventricular Ejection Fraction, Calculated (%) | RVEF_C | 2 | 75 | Visit 1 (Baseline) | 1 | 16MAY2022 | Y | 75 |
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| | 3 | DMD-EFLGE | DMD-EF-01-101 | 07FEB2010 | Drug A | Drug A | Y | 1.08 | Y | 900 | Left Ventricular Ejection Fraction, Calculated (%) | LVEF_C | 1 | 65 | Visit 6 (1 Year) | 6 | 06APR2023 |
| 70 | -5 | -10.447761 | Decline >=5.0% | | 4 | DMD-EFLGE | DMD-EF-01-101 | 07FEB2010 | Drug A | Drug A | Y | 1.08 | Y | 900 | Right Ventricular Ejection Fraction, Calculated (%) | RVEF_C | 2 | 70 | Visit 6 (1 Year) | 6 | 06APR2023 |
| 75 | -5 | -17.567568 | Decline >=5.0% |
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Example Analysis Results Metadata (ARM) Tables
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