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Table 1. A simple comparison of change by treatment groups over one year.
Display | Table 14.xx.xx Change in Left Ventricular Ejection Fraction Percent Over 1 Year |
|---|---|
| Analysis Result | Comparison of Change of Ejection Fraction Percent for the Treatment Groups (1 Year) |
| 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" and AVISITN = 6; |
| Documentation | Comparison of Means with 95% confidence interval |
Programming Statements (Add programming language statements here: SAS, R, etc.) | Proc means DATA=ADCVNTP N MEAN clm STDERR; /* Subset the data. Can run again selecting for paramcd="RVEF_C"*/ Where PARAMCD = |
"LVEF_C |
" and ITTFL = "Y" and AVISITN = 6 ; Class TRT01P; Var CHG; run; |
Table 2. This table demonstrates a model over multiple time points.
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 (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; |
Table 3. This example uses the dataset ADCVCMR, with 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 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; |
| Pagenav2 |
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