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For more details on ARM, see the ADaMIG and the Analysis Results Metadata (ARM) v1.0 for Define-XML v2.0 (https://www.cdisc.org/standards/foundational/adam).
Table 1. A simple comparison of change by treatment groups over one year.
Display | Table 14.xx.xx Percent Change in Left Ventricular Ejection Fraction Over 1 Year |
|---|---|
| Analysis Result | Comparison of Percent Change of Ejection Fraction for the Treatment Groups (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 = 26; |
| Documentation | Comparison of Means with 95% confidence interval |
Programming Statements (Add programming language statements here: SAS, R, etc.) | /* Subset the data */ DATA ONE; SET ADCVCMR; Where ITTFL = "Y" and AVISITN = 2; RUN; PROC MEANS DATA=ADCVCMR ONE MEAN STD MEDIAN printalltypes maxdec=3 ; CLASS TRT01P; VAR LVEF; /* Could add RVEF here as well */ RUN; |
Table 2, ADD SOME COVARIATES TO THE MODEL. 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 Over Time (Yearly) |
|---|---|
| Analysis Result | Comparison of Percent Change of Ejection Fraction for the Treatment Groups Over Time ( 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.) | /* Note that PCHG is only computed post-baseline, so subset for the yearly visits, i.e. 6, 12, 18 etc. */ DATA TWO; SET ADCVCMR; IF PARAMCD = "LVEFC"; /* Subset by param, as there are two parameters with CHG calculated*/ Where ITTFL = "Y" and AVISITN = 2; RUN; PROC MIXED DATA=ADCVNTP; CLASS STUYDID TRT01P AVISITN; MODEL PCHG=AVISITN* 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; |
Move to table 3 This example uses the dataset ADCVNTP, selecting for the parameter "N-Terminal ProB-type Natriuretic Peptide (IU/L)".
Display | Table 14.xx.xx Percent change in NTproBNP over a period of time (yearly)1 Year |
|---|---|
| Analysis Result | Comparison of Percent Change of NTproBNP for the Treatment Groups Over Time (yearly)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 = "BNPPRONT" Where ITTFL = "Y" AND AVISIT GE 6; |
| Documentation | The mixed model using lsmeans to compare treatment groups |
Programming Statements (Add programming language statements here: SAS, R, etc.) | PROC MIXEDMEANS DATA=ADCVNTP; WHERE PARAMCD = "BNPPRONT"; CLASS STUYDID TRT01P AVISITN; MODEL PCHG=AVISITN*TRT01P/Solution; RANDOM INTERCEPT / SUBJECT=STUYDID TYPE=UN; ADCVCMR MEAN STD MEDIAN maxdec=3; CLASS TRT01P; BY VISIT; VAR BNPPRONT; LSMEANS TRT01P*AVISITN/ CL PDIFF; RUN; |
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