| Variable Name | Variable Label | Type | Codelist/Controlled Terms/Format | Source | Derivation/Comment |
|---|
| 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) | DM.SEX | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-16 |
|---|
|
|
|
RACE | Race | Num | (RACE) | DM.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 relates| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-12 |
|---|
|
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. |