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The dataset above can also be set up to provide multivariate analyses by taking the lab tests of interest (Paramcd = BNPPRONT) or other analysis datasets, and and merging variables of interest with the ADCVNTP dataset. This summary dataset is created from other ADaM datasets as the source and only variable used in the analysis are kept.
| Definexmltable |
|---|
| Dataset | ADCVCMR |
|---|
| Level | Variable |
|---|
| Purpose | Analysis |
|---|
| Name | Variable |
|---|
|
| Variable Name | Variable Label | Type | Codelist/Controlled Terms/Format | Source | Derivation/Comment |
|---|
| STUDYID | Study Identifier | Char |
| ADCVNTP.STUDYID |
| | USUBJID | Unique Subject Identifier | Char |
| |
| | BRTHDT | Date of Birth | Num | date9. | ADCVNTP.BRTHDT |
| | AAGE | Analysis Age | Num |
| ADCVNTP.AAGE |
| | AGEU | Age Unit | Char | YEARS | ADCVNTPL.AGEU |
| SEX | Sex | Char | (SEX) | ADCVNTPL.SEX |
| RACE | Race | Num | (RACE) | ADCVNTPL.RACE |
| | 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 | | | BSA | Body Surface Area (m2) | Num |
| ADCVNTP.BSA |
| ACEINHFL | ACE Inhibitor Medications Flag | Char | Y; N | ADCVNTP.ACEINHFL |
| BNPPRONT |
| Num |
|
| 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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