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Table 2. This table demonstrates a model over multiple time points, adding some of the covariates that were retained in the analysis dataset.
Display | Table 14.xx.xx Percent Change in Left Ventricular Ejection Fraction Percent Over Time (Yearly) |
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Analysis Result | Comparison of Percent Change of Ejection Fraction for the Treatment Groups Over Time ( yearly) |
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 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 mixed DATA=ADCVNTP; 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; RUN; |
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Table 3. This example uses the dataset ADCVCMR, with with AGE, SEX, RACE, and BNPPRONT as an additional covariatecovariates.
Display | Table 14.xx.xx Percent change in NTproBNP over 1 Year |
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Analysis Result | Comparison of Percent Change of NTproBNP for the Treatment Groups Over a period of time. |
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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