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Display | Table 14.xx.xx Percent Change in Left Ventricular Ejection Fraction Over Time1 Year |
|---|---|
| Analysis Result | Comparison of Percent Change of Ejection Fraction for the Treatment Groups Over Time (quarterly or yearly(1 Year) |
| 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 = "LVEFC" Where ITTFL = "Y" and AVISITN = 2; |
| Documentation | The mixed model using lsmeans to compare treatment groupsComparison of Means with 95% confidence interval |
Programming Statements (Add programming language statements here: SAS, R, etc.) | PROC MIXEDMEANS DATA=ADCVCMR MEAN STD MEDIAN printalltypes maxdec=3; CLASS STUYDID CLASS TRT01P AVISITN; MODEL PCHG=AVISITN*TRT01P/Solution; RANDOM INTERCEPT / SUBJECT=STUYDID TYPE=UN; LSMEANS TRT01P*AVISITN/ CL PDIFF;VAR LVEF; /* Could add RVEF here as well */ RUN; |
Table 2, ADD SOME COVARIATES TO THE MODEL
Display | Table 14.xx.xx Percent Change in Left Ventricular Ejection Fraction Over Time (Yearly) |
|---|---|
| Analysis Result | Comparison of Percent Change of Ejection Fraction for the Treatment Groups Over Time ( quarterly or yearly) |
| 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 = "LVEFC" Where ITTFL = "Y" |
| Documentation | The mixed model using lsmeans to compare treatment groups |
Programming Statements (Add programming language statements here: SAS, R, etc.) | PROC MIXED DATA=ADCVNTP; CLASS STUYDID TRT01P AVISITN; MODEL PCHG=AVISITN*TRT01P/Solution; RANDOM INTERCEPT / SUBJECT=STUYDID TYPE=UN; LSMEANS TRT01P*AVISITN/ CL PDIFF; RUN; |
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