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The SDTM examples used as the source data are from Section 2.1, Basic Systolic Function. The records in the CV dataset for which CVTESTCD = "LVEF_C" and "RVEF_C" were selected for analysis. The records in the LB dataset where LBTESTCD = "BNPPRONT" were used to compute the percent change over time and as a potential covariate.
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Definexmltable |
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Dataset | ADCVNTP |
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Level | Value |
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Purpose | Analysis |
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OID | AVAL |
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Dataset | Variable | Where | Type | Origin | Derivation/Comment |
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ADCVNTP | AVAL | PARAMCD in ("LVEF_C", "RVEF_C") | Num | Predecessor | Set to CV.CVSTRESN | ADCVNTP | AVAL | PARAMCD = "BNPPRONT" | Num | Predecessor | Set to LB.LBSTRESN where LB.LBTESTCD = "BNPPRONT" | ADCVNTP | CHGCAT1 | PARAMCD in ("LVEF_C", "RVEF_C") | Char |
| Categorize the value of CHGCAT1 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 not missing and 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-10 |
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" | ADCVNTP | CHGCAT1 | PARAMCD = "BNPPRONT" | Char |
| 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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" |
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Definexmltable |
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Dataset | ADCVNTP |
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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 |
| CV.STUDYID |
| USUBJID | Unique Subject Identifier | Char |
| |
| BRTHDT | Date of Birth | Num | Date9. | ADSL.BRTHDT |
| AAGE | Analysis Age | Num |
| ADSL.AAGE |
| AGEU | Age Unit | Char | YEARS | ADSL.AGEU |
| SEX | Sex | Char | (SEX) | 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 | Num | (RACE) | ADSL.RACE |
| TRTSDT | Date of First Exposure to Treatment | Num | date9 | ADSL.TRTSDT |
| TRT01P | Planned Treatment for Period 01 | Char | Drug A; Drug B | ADSL.TRT01P |
| TRT01A | Actual Treatment for Period 01 | Char | Drug A; Drug B | ADSL.TRT01A |
| ITTFL | Intent-To-Treat Population Flag | Char | Y; N | ADSL.ITTFL | | HEIGHT | Height (cm) | Num |
|
| Set to VS.VSSTRESN where VS.VSTEST = "HEIGHT" by visit. | WEIGHT | Weight (kg) | Num |
|
| Set to VS.VSSTRESN where VS.VSTEST = "WEIGHT" by visit. | BSA | Body Surface Area (m2) | Num |
|
| 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 | Char | Y; N | ADSL.ACEINHFL |
| PARAM | Parameter | Char | Left Ventricular Ejection Fraction, Cal (%); Right Ventricular Ejection Fraction, Cal (%); N-Terminal ProB-type Natriuretic Peptide (ng/L) | CV.CVTEST LB.LBTEST |
| PARAMCD | Parameter Code | Char | LVEF_C; RVEF_C; BNPPRONT | CV.CVTESTCD LB.LBTESTCD |
| PARAMN | Parameter (N) | Num |
|
| Number PARAMCD as follows: LVEF_C = "1" RVEF_C = "2" BNPPRONT = "3" | AVAL | Analysis Value | Num |
|
| See Parameter Value Metadata | AVISIT | Analysis Visit | Char | 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) | Num | 1; 6 | CV.VISITNUM LB.VISITNUM |
| VISIT | Visit | Num | VISIT 1; VISIT 6 | CV.VISIT LB.VISIT |
| ADT | Analysis Date | Num | date9. |
| Date portion of CV.CVDTC or LB.LBDTC converted to numeric and displayed in a format such as date9. | ABLFL | Baseline Record Flag | Char | Y |
| If CV.VISIT = "VISIT 1" then ABLFL = "Y". | BASE | Baseline Value | Num |
|
| 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 | Num |
|
| Compute CHG = AVAL - BASE for that record. Only compute for post-baseline records. | PCHG | Percent Change from Baseline | Num |
|
| Compute PCHG = (CHG / BASE) * 100. Only compute for post-baseline records. | CHGCAT1 | Change from Baseline Category 1 | Char | Decline >=5%; Decline <5%; Increase GT 100 ng/L |
| See Parameter Value Metadata | SRCDOM | Source Data | Char | CV; LB |
| Set to the SDTM domain name that relates to the analysis value. | SRCVAR | Source Variable | Char |
|
| Set to the SDTM variable that relatesrelates 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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to the analysis value. | SRCSEQ | Source Sequence Number | Num |
| CV.CVSEQ LB.LBSEQ | Set to the SDTM domain sequence number that relates to the analysis value. |
|
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