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Comment: added ARM table

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  • From CV domain
    • Percent change in ejection fraction over time
    • Decline in ejection fraction over a time period (yearly) grouped by a decline greater than x.x%.
  • From the LB domain
    • Percent change in NTproBNP over a period of time (yearly).

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The dataset above can also be set up to provide multivariate analyses by taking the lab tests of interest, transposing and merging with the ADCVNTPP dataset. In that case, the records from LB are not needed as a row.

The variables transposed and merged to the rows created from CV are:

DatasetValueWhere Variable Variable Label
ADCVNTPAVALPARAMCD ="BNPPRONT"BNPPRONTN-Terminal ProB-type Natriuretic Peptide (IU/L)
ADCVNTPCHGCAT1PARAMCD ="BNPPRONT"BNPPRCHGN-Term ProB-type N Pep Change Category
Dataset wrap
Nameadcvntp
Dataset2
tableidadcvntp
RowSTUDYIDUSUBJIDASEQBSABASEBNPPRONTBNPPRCHGPARAMPARAMCDPARAMNAVALAVISITAVISITNVISITADTABLFLBASECHGPCHGTRT01PITTFLAGEAGEUSEXSRCDOMSRCSEQ
1DMD-EFLGEDMD-EFLGE-10110.6540
Left Ventricular Ejection Fraction, Calculated (%)LVEFC167Visit 1 (Month 1)1VISIT 116May2022Y67

Treatment AY8YEARSMCV3
2DMD-EFLGEDMD-EFLGE-10120.6540
Right Ventricular Ejection Fraction, Calculated (%)RVEFC274Visit 1 (Month 1)1VISIT 116May2022Y74

Treatment AY8YEARSMCV7
3DMD-EFLGEDMD-EFLGE-10130.65900> 1.0 (IU/L)Left Ventricular Ejection Fraction, Calculated (%)LVEFC160Visit 6 (Month 12)6VISIT 601Jun2023
67-7-10.447761Treatment AY8YEARSMCV11
4DMD-EFLGEDMD-EFLGE-10140.65900> 1.0 (IU/L)Right Ventricular Ejection Fraction, Calculated (%)RVEFC261Visit 6 (Month 12)6VISIT 601Jun2023
74-13-17.567568Treatment AY8YEARSMCV15

Example Analysis Results Metadata (ARM) Table

This table may be included in the submission package for regulatory agencies. It describes the analyses conducted for the study (usually limited to primary and secondary  endpoints) with details on data and analysis procedures used. The example below would be repeated for each additional parameter, i.e 

Display

Table 14.xx.xx Percent Change in Left Ventricular Ejection Fraction Over Tme

Analysis ResultComparison of Percent Change of Ejection Fraction for the Treatment Groups Over Time (quarterly or yearly)
Analysis Variables(s)PCHG
Analysis ReasonPrimary efficacy endpoint as prespecified in the SAP
Analysis PurposePrimary 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;

Info

Ejection Fraction

  • change in ejection fraction, would expect a decline in EF 2-3% per year, would prefer an improvement or no change. Concerning if rapid progression, 10% decline or more, for example.

NTproBNP

  • % change over a period of time – a decrease would mean improvement, annually is appropriate

SDTM Examples: Basic CMR tests - Systolic Function

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