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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 | Description | Class | Structure | Purpose | Keys | Location | Documentation |
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ADSL | Subject-Level Analysis Dataset | SUBJECT LEVEL ANALYSIS DATASET | One record per subject. | Analysis | USUBJID | adsl.xpt | ADSL.SAS | | ADEFNTP | CV MRI EF and NT-proBNP Analysis | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter. | Analysis | USUBJID, AVISITN, PARAMN | adefntp.xpt | ADEFNTP.SAS/SAPSee SAP, Section X.X.X | Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TAUGDMDCIS-4 |
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| | ADEFMRI | CV MRI Ejection Fraction Analysis | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter. | Analysis | USUBJID, AVISITN, PARAMN | adcvcmradefmri.xpt | See SAP, Section X.X.XADEFMRI/SAP |
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ADSL
The ADSL contains subject characteristics and covariates that are important for analyses. Stratification variables can be created in the ADSL to subset the data. More than one SDTM dataset may be used as input to the ADSL. This is a simplified example ADSL dataset; the ADaMIG should be referenced for additional variables.| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TAUGDMDCIS-2 |
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...
| Dataset wrap |
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| Dataset2 |
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| | Row | STUDYID | USUBJID | BRTHDT | AAGE | AGE | AGEU | SEX | RACE | TRTSDT | RFICDT | DTHDT | DTHFL | TRT01P | ITTFL | ACEINHFL | HEIGHTSC | WEIGHTSC | BSASC |
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| 1 | DMD-EFLGE | DMD-EF-01-101 | 07FEB2010 | 12.3 | 12 | YEARS | M | BLACK OR AFRICAN AMERICAN | 16JUN2022 | 16JUN2022 |
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| Drug A | Y | Y | 119 | 20 | 0.82 | | 2 | DMD-EFLGE | DMD-EF-01-101 | 01MAY2008 | 14.1 | 14 | YEARS | M | ASIAN | 13JUN2022 | 13JUN2022 |
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| Drug A | Y | Y | 115 | 30 | 0.95 | | 3 | DMD-EFLGE | DMD-EF-01-101 | 10JUL2003 | 19.0 | 19 | YEARS | M | NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER | 15JUL2022 | Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TAUGDMDCIS-7 |
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| 15JUL2022 |
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| Drug B | Y | N | 140 | 45 | 1.30 | | 4 | DMD-EFLGE | DMD-EF-01-101 | 15JAN1999 | 23.7 | 23 | YEARS | M | WHITE | 06SEP2022 | 06SEP2022 | 23NOV2023 | Y | Drug B | Y | Y | 132 | 42 | 1.21 |
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ADEFNTP
The ADCVNTP ADEFNTP includes tests pertinent to analyses. The records from CV (CVTESTCD = "LVEF_C" and "RVEF_C") and the records from LB (LBTESTCD = "BNPPRONT") were selected. Many lab draws may occur throughout the year, but only those linked to a specific visit were included. By subsetting the LB dataset by LBLNKID not missing, laboratory data that aligns with CV data can be filtered out and sorted using USUBJID and VISIT. If LBLNKID is not available or the LB dataset does not contain VISIT, a windowing strategy could be used to select the laboratory draw closest to that visit using date of lab draw (LB.LBDTC.).
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| Dataset wrap |
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| Dataset2 |
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| | Row | STUDYID | USUBJID | AAGE | AGEU | SEX | RACE | TRT01P | TRT01A | ITTFL | 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 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 119 | 20 | 0.82 | Y | Left Ventricular Ejection Fraction, Cal (%) | LVEF_C | 1 | 67 | Visit 1 (Baseline) | 1 | VISIT 1 | 16MAY2022 | Y | 67 |
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| CV | CVTESTCD| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TAUGDMDCIS-13 |
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| 3 | | 2 | DMD-EFLGE | DMD-EF-01-101 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 119 | 20 | 0.82 | Y | Right Ventricular Ejection Fraction, Cal (%) | 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 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 119 | 20 | 0.82 | Y | N-Terminal ProB-type Natriuretic Peptide (ng/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 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 132 | 32 | 1.08 | Y | Left Ventricular Ejection Fraction, Cal (%) | 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 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 132 | 32 | 1.08 | Y | Right Ventricular Ejection Fraction, Cal (%) | 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 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 132 | 32 | 1.08 | Y | N-Terminal ProB-type Natriuretic Peptide (ng/L) | BNPPRONT | 3 | 900 | Visit 6 (1 Year) | 6 | VISIT 6 | 06APR2023 |
| 40 | 860 | 2,150 | Increase >100 ng/L | LB | LBTESTCD | 2 |
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ADEFMRI
The ADCVMR is an efficacy analysis dataset with only a few records for more complex modeling of changes in ejection fraction, plus the proB-type test results. It is an ADaM Basic Data Structure (BDS) dataset| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TAUGDMDCIS-15 |
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, with additional variables added from ADCVNTPADEFNTP dataset.
The dataset can provide multivariate analyses
| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TAUGDMDCIS-14 |
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by taking the lab tests of interest (PARAMCD = "BNPPRONT") or other analysis datasets, and merging variables of interest with the
ADCVNTP ADEFNTP dataset. This summary dataset is created from other ADaM datasets and only variables 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 | Source/Derivation/Comment |
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| STUDYID | Study Identifier | text |
| Predecessor: ADCVNTPADEFNTP.STUDYID | | USUBJID | Unique Subject Identifier | text |
| Predecessor: ADCVNTPADEFNTP.USUBJID | | BRTHDT | Date of Birth | integer | date9. | Predecessor: ADCVNTPADEFNTP.BRTHDT | | AAGE | Analysis Age | float |
| Predecessor: ADCVNTPADEFNTP.AAGE | | AGEU | Age Unit | text | YEARS | Predecessor: ADCVNTPADEFNTP.AGEU | SEX | Sex | text | (SEX) | Predecessor: ADCVNTPADEFNTP.SEX | RACE | Race | text | (RACE) | Predecessor: ADCVNTPADEFNTP.RACE | | TRTSDT | Date of First Exposure to Treatment | Num | date9. | Predecessor: ADCVNTPADEFNTP.TRTSDT | | TRT01P | Planned Treatment for Period 01 | text | Drug A; Drug B | Predecessor: ADCVNTPADEFNTP.TRT01P | ITTFL | Intent-To-Treat Population Flag | text | Y; N | Predecessor: ADCVNTPADEFNTP.ITTFL | | BSA | Body Surface Area (m2) | float |
| Predecessor: ADCVNTPADEFNTP.BSA | ACEINHFL | ACE Inhibitor Medications Flag | text | Y; N | Predecessor: ADCVNTPADEFNTP.ACEINHFL | BNPPRONT |
| integer |
| Derived: BNPPRONT = AVAL where PARAMCD = ADCVNTPADEFNTP.BNPPRONT, and merge by USUBJID and AVISITN. Note: There are many ways to add this including transposing the data. | | PARAM | Parameter | text | Left Ventricular Ejection Fraction, Cal (%); Right Ventricular Ejection Fraction, Cal (%) | Predecessor: ADCVNTPADEFNTP.PARAM | | PARAMCD | Parameter Code | text | LVEF_C; RVEF_C | Predecessor: ADCVNTPADEFNTP.PARAMCD | | PARAMN | Parameter (N) | integer |
| Predecessor: ADCVNTPADEFNTP.PARAMN | | AVAL | Analysis Value | float |
| Predecessor: ADCVNTPADEFNTP.AVAL | | AVISIT | Analysis Visit | text | Visit 1 (Baseline); Visit 6 (1 Year) | Predecessor: ADCVNTPADEFNTP.AVISIT | | AVISITN | Analysis Visit (N) | integer | 1; 6 | Predecessor: ADCVNTPADEFNTP.AVISITN | | ADT | Analysis Date | float | date9. | Predecessor: ADCVNTPADEFNTP.ADT | | ABLFL | Baseline Record Flag | text | Y | Predecessor: ADCVNTPADEFNTP.ABLFL | | BASE | Baseline Value | float |
| Predecessor: ADCVNTPADEFNTP.BASE | | CHG | Change from Baseline | float |
| Predecessor: ADCVNTPADEFNTP.CHG | | PCHG | Percent Change from Baseline | float |
| Predecessor: ADCVNTPADEFNTP.PCHG | | CHGCAT1 | Change from Baseline Category 1 | text | Decline >=5.0%; Decline <5.0%; Increase >100 ng/L | Predecessor: ADCVNTPADEFNTP.CHGCAT1 |
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| Dataset wrap |
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| Show | true |
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| Name | adcvcmradefmri |
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| Dataset2 |
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| | Row | STUDYID | USUBJID | BRTHDT | TRT01P | AAGE | AGU | SEX | RACE | 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 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Y | 0.82 | Y | 40 | Left Ventricular Ejection Fraction, Cal (%) | 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 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Y | 0.82 | Y | 40 | Right Ventricular Ejection Fraction, Cal (%) | 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 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Y | 1.08 | Y | 900 | Left Ventricular Ejection Fraction, Cal (%) | 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 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Y | 1.08 | Y | 900 | Right Ventricular Ejection Fraction, Cal (%) | RVEF_C | 2 | 70 | Visit 6 (1 Year) | 6 | 06APR2023 |
| 75 | -5 | -17.567568 | Decline >=5.0% |
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