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| 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 |
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| STUDYID | Study Identifier | Char |
| ADCVNTP.STUDYID |
| | USUBJID | Unique Subject Identifier | Char |
| |
| | BRTHDT | Date of Birth | Num | Date9date9. | 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 |
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| 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
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| 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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| Dataset wrap |
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| Show | true |
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Name | adcvcmr |
Example Analysis Results Metadata (ARM) Tables
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