...
Dataset wrap |
---|
|
Dataset2 |
---|
| Row | STUDYID | USUBJID | BRTHDT | TRTSDT | TRT01P | ITTFL | BSABASE | ACENHFL |
---|
1 | DMD-EFLGE | DMD-EFLGE-101 | 15FEB2021 | 16MAY2022 | Treatment A | Y | 0.65 | Y |
|
|
Definexmltable |
---|
Dataset | ADCVNTP |
---|
Level | Value |
---|
Purpose | Analysis |
---|
OID | AVAL |
---|
|
Dataset | Variable | Where | Type | Origin | Derivation/Comment |
---|
ADCVNTP | AVAL | PARAMCD = "LVEFC" | Num | Predecessor | Set to CV.CVSTRESN where CV.CVTESTCD = "LVEF_C" | ADCVNTP | AVAL | PARAMCD = "RVEFC" | Num | Predecessor | Set to CV.CVSTRESN where CV.CVTESTCD = "RVEF_C" | ADCVNTP | AVAL | PARAMCD = "BNPPRONT" | Num | Predecessor | Set to LB.LBSTRESN where LB.LBTESTCD = "BNPPRONT" |
|
Analysis Datasets for Ejection Fraction
The subsequent section provides the data structures for the example ADaM datasets. In this example, columns for derived variables BASE, CHG, PCHG and CHGCAT1 have been added to facilitate analyses of the efficacy endpoints. Specifically, example demographic data for ADSL were created for an 8 year old male. Also, a custom variable for BSA at baseline (BSABASE), and an example of a stratification variable for subjects with was added from ADSL.
...