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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 specified 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 ADEFNTP 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; |
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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 (Yearly) |
| Analysis Variables(s) | CHG |
| Analysis Reason | Primary efficacy endpoint as specified 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=ADCVNTPADEFNTP; Class TRT01P AVISITN; /* Subset by param, as there are 2 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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Display | Table 14.xx.xx Percent change in NT-proBNP over time (1 year) |
|---|---|
| Comparison of Percent Change of Ejection Fraction NT-proBMP for the Treatment Groups Over Time (Yearly) | |
| Analysis Variables(s) | CHG |
| Analysis Reason | Primary efficacy endpoint as specified in the SAP |
| Analysis Purpose | Primary outcome measure |
Data References (incl. selection criteria) | PARAMCD = "BNPPRONT" 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=ADCVNTPADEFNTP; Class TRT01P AVISITN; /* Subset by param, as there are 2 parameters with CHG calculated*/ Where ITTFL = "Y" and AVISITN IN (6, 12, 18, 24, 36, 48) and PARAMCD = "BNPPRONT"; Model PCHG=AVISITN*TRT01P/Solution; RANDOM INTERCEPT / SUBJECT=STUYDID TYPE=UN; LSMEANS TRT01P*AVISITN/ CL PDIFF; run; |
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Table 4. This example uses the dataset ADCVCMRADEFMRI, 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 specified 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=ADCVCMRADEFMRI; Where PARAMCD = "L_VEFC" and ITTFL = "Y" and AVISITN GE 6; By TRT01P; Model PCHG = AAGE SEX RACE BNPPRONT
run; |
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