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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/SAP | 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 | adefmri.xpt | |
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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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| 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-8 |
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| Definexmltable |
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| Dataset | ADCVNTPADEFNTP |
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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: CV.STUDYID | | USUBJID | Unique Subject Identifier | text |
| Predecessor: CV.USUBJID | | BRTHDT | Date of Birth | integer | date9. | Predecessor: ADSL.BRTHDT | | AAGE | Analysis Age | float |
| Predecessor: ADSL.AAGE | | AGEU | Age Unit | text |
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Predecessor: ADSL.AGEU | SEX | Sex | text | (SEX) | Predecessor: ADSL.SEX | 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-16 |
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| RACE | Race | text | (RACE) | Predecessor: ADSL.RACE | | TRTSDT | Date of First Exposure to Treatment | integer | date9 | Predecessor: ADSL.TRTSDT | | TRT01P | Planned Treatment for Period 01 | text | Drug A; Drug B | Predecessor: ADSL.TRT01P | | TRT01A | Actual Treatment for Period 01 | text | Drug A; Drug B | Predecessor: ADSL.TRT01A | ITTFL | Intent-To-Treat Population Flag | text | Y; N | | HEIGHT | Height (cm) | float |
| Set to VS.VSSTRESN where VS.VSTEST = "HEIGHT" by visit. | WEIGHT | Weight (kg) | float |
| Set to VS.VSSTRESN where VS.VSTEST = "WEIGHT" by visit. | | BSA | Body Surface Area (m2) | float |
| Derived: Compute from HEIGHT and WEIGHT at each visit, using the Du Bois method. BSA = 0.007184 × W0.425 × H0.725 There are multiple methods for calculating BSA; the study protocol should describe which to use. | ACEINHFL | ACE Inhibitor Medications Flag | text | Y; N | Predecessor: ADSL.ACEINHFL | | PARAM | Parameter | text | Left Ventricular Ejection Fraction, Cal (%); Right Ventricular Ejection Fraction, Cal (%); N-Terminal ProB-type Natriuretic Peptide (ng/L) | Predecessor: CV.CVTEST LB.LBTEST | | PARAMCD | Parameter Code | text | LVEF_C; RVEF_C; BNPPRONT | Predecessor: CV.CVTESTCD LB.LBTESTCD | | PARAMN | Parameter (N) | integer | 1; 2; 3; | Assigned: Number PARAMCD as follows: LVEF_C = "1" RVEF_C = "2" BNPPRONT = "3" | | AVAL | Analysis Value | float |
| See Parameter Value Metadata | | AVISIT | Analysis Visit | text | Visit 1 (Baseline); Visit 6 (1 Year) | If CV.VISIT = "VISIT 1" then AVISIT = "Visit 1 (Baseline)". If CV.VISIT = "VISIT 6" then AVISIT = "Visit 6 (1 Year)". | | AVISITN | Analysis Visit (N) | integer | 1; 6 | Predecessor: CV.VISITNUM LB.VISITNUM | | VISIT | Visit | integer | VISIT 1; VISIT 6 | Predecessor: CV.VISIT LB.VISIT | | ADT | Analysis Date | integer | date9. | Date portion of CV.CVDTC or LB.LBDTC converted to numeric and displayed in a format such as date9. | | ABLFL | Baseline Record Flag | text | Y | Derived: If CV.VISIT = "VISIT 1" then ABLFL = "Y". | | BASE | Baseline Value | float |
| Derived: Set BASE to AVAL from the record for that subject and parameter where ABLFL = "Y". Populate BASE for additional visits by merging the value of BASE in the baseline record by USUBJID and PARAMCD. | | CHG | Change from Baseline | float |
| Derived: Compute CHG = AVAL - BASE for that record. Only compute for post-baseline records. | | PCHG | Percent Change from Baseline | float |
| Derived: Compute PCHG = (CHG / BASE) * 100. Only compute for post-baseline records. | | CHGCAT1 | Change from Baseline Category 1 | text | Decline >=5%; Decline <5%; No decline | See Parameter Value Metadata | | SRCDOM | Source Data | text | CV; LB | Assigned: Set to the SDTM domain name that relates to the analysis value. | | SRCVAR | Source Variable | text | CVSTRESN; LBSTRESN | Assigned: Set to the SDTM variable that relates to the analysis value.| 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-12 |
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| | SRCSEQ | Source Sequence Number | integer |
| Predecessor: CV.CVSEQ LB.LBSEQ Set to the SDTM domain sequence number that relates to the analysis value, CV.CVSEQ or LB.LBSEQ.
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In this example, variables BASE, CHG, PCHG, and CHGCAT1 were added to facilitate analyses of the efficacy endpoints. the variables SRCDOM, SRCVAR, and SRCSEQ provide traceability to the combined source datasets. Thes The tables below represent parameter value level lists for applicable variables.
| Definexmltable |
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| Dataset | ADEFNTP |
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| Example | trueADCVNTP |
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| Level | ValueCodelist |
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| Purpose | Analysis |
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| Name | AVAL |
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| OID | C.PARAM.ADCVNTP |
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| Name | Parameter |
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| Permitted Value (code) |
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Left Ventricular Ejection Fraction, Cal (%); | | Right Ventricular Ejection Fraction, Cal (%); | | N-Terminal ProB-type Natriuretic Peptide (ng/L) |
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| Definexmltable |
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| Dataset | ADEFNTP |
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| Example | true |
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| Level | Codelist |
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| Purpose | Analysis |
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| OID | CL.PARAMCD.ADEFNTP |
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| Name | Parameter Code |
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| Permitted Value (code) | Display Value (Decode) |
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LVEF_C | Left Ventricular Ejection Fraction, Cal (%); | | RVEF_C | Right Ventricular Ejection Fraction, Cal (%); | | BNPPRONT | N-Terminal ProB-type Natriuretic Peptide (ng/L) |
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| Definexmltable |
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| Dataset | ADCVNTP |
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| Level | Codelist |
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| Purpose | Analysis |
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| Name | AVAL |
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| Variable | Where | Type | Controlled Terms or Format | Origin | Derivation/Comment |
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| AVAL | CV.CVSTRESN IN |
| Variable | Where | Type | Origin | Derivation/Comment |
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AVAL | PARAMCD in | ("LVEF_C", "RVEF_C") | float |
| Predecessor | CV.CVSTRESN | | AVAL |
PARAMCD | LB.LBTESTCD = "BNPPRONT" | float |
| Predecessor | LB.LBSTRESN |
where LB.LBTESTCD = "BNPPRONT" |
In this table the ADaM parameters are used rather than the source SDTM data.
| Definexmltable |
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| Dataset | ADCVNTP |
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| Level | ValueCodelist |
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| Purpose | Analysis |
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| Name | CHGCAT1 |
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| Variable | Where | Type | Controlled Terms or Format | Origin | Derivation/Comment |
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| CHGCAT1 | PARAMCD in ("LVEF_C", "RVEF_C") | text | Decline >=5% Decline <5% No Decline | Derived | Categorize the value of CHGCAT1 CHG as follows: If CHG >= 5.00 THEN CHGCAT1 = "Decline >=5%". | 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-9 |
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Else if CHG GT 0 and CHG < 5.00 THEN CHGCAT1 = "Decline <5%" Else if CHG <0 then CHGCAT1 = "No Decline." | 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-10 |
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| | CHGCAT1 | PARAMCD = "BNPPRONT" | text | Increase >100 ng/L Increase <=100 ng/L No increase | Derived | Categorize the value of CHCAT1 as follows: "Increase >100 ng/L"; "Increase <=100 ng/L"; "No increase" | 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-11 |
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