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Display | Table 14.xx.xx Percent Change in Left Ventricular Ejection Fraction Percent Over Time (Yearly) |
|---|---|
| Analysis Result | Comparison of Percent Change of Ejection Fraction for the Treatment Groups Over Time (yearlyYearly) |
| Analysis Variables(s) | CHG |
| Analysis Reason | Primary efficacy endpoint as prespecified in the SAP |
| Analysis Purpose | Primary outcome measure |
Data References (incl. selection criteria) | PARAMCD = "LVEF_C" Where ITTFL = "Y" |
| Documentation | The The mixed model using lsmeans to compare treatment groups |
Programming Statements (Add programming language statements here: SAS, R, etc.) | /* Note that CHG is only computed post-baseline, so subset for the yearly visits, i.e. 6, 12, 18, etc. */ Proc Proc mixed DATA=ADCVNTP; Class Class TRT01P AVISITN; /* Subset by param, as there are two parameters with CHG calculated*/ Where ITTFL = "Y" and AVISITN IN (6, 12, 18, 24, 36, 48) and PARAMCD = "LVEF_C"; Model PCHG=AVISITN*TRT01P/Solution; RANDOM INTERCEPT / SUBJECT=STUYDID TYPE=UN; LSMEANS TRT01P*AVISITN/ CL PDIFF; RUNrun; |
Table 3. This example uses the dataset ADCVCMR, with AGE, SEX, RACE, and BNPPRONT as covariates.
Display | Table 14.xx.xx Percent change in NTproBNP over 1 Year |
|---|---|
| Analysis Result | Comparison of Percent Change of NTproBNP for the Treatment Groups Over a period of timeTime. |
| Analysis Variables(s) | PCHG |
| Analysis Reason | Primary efficacy endpoint as prespecified in the SAP |
| Analysis Purpose | Primary outcome measure |
Data References (incl. selection criteria) | PARAMCD = "L_VEFC"; ITTFL = "Y" and AVISITN GE 6; |
| Documentation | Multiple Regression Model |
Proc reg data=ADCVCMR; Where PARAMCD = "L_VEFC" and ITTFL = "Y" and AVISITN GE 6; Model PCHG = AAGE SEX RACE BNPPRONT; run; |
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