The Analysis Results Metadata tables may be generated for submissions to regulatory agencies as part of the Define XML. The format below in this example is a rendering of the information that should be produced to describe primary and secondary endpoint outputs. They are presented here as an examle of the types of analyses that may be produced to explore the endpoints presented in the previous section. These are not currently required by most regulatory agencies, although they are considered a "nice to have" feature. 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).
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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 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 table demonstrates a model over multiple time points.
Display | Table 14.xx.xx Percent change in NT-proBNP over time (1 year) |
|---|---|
| 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 = "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=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 = "BNPPRONT"; Model PCHG=AVISITN*TRT01P/Solution; RANDOM INTERCEPT / SUBJECT=STUYDID TYPE=UN; LSMEANS TRT01P*AVISITN/ CL PDIFF; run; |
Table 4. This example uses the dataset ADCVCMR, with AGE, SEX, RACE, and BNPPRONT as covariates.
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