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Dataset wrap
Nameadcvntp
Rowcaps
Rows 1-2:Show the baseline ejection fraction measurements at VISIT 1.
Row 3:Shows the baseline N-Terminal ProB-type Natriuretic Peptide test results at VISIT 1.
Rows 4-5:Show the baseline ejection fraction measurements at VISIT 6.
Row 6:Shows the baseline N-Terminal ProB-type Natriuretic Peptide test results at VISIT 6.
Dataset2
tableidadcvntp
RowSTUDYIDUSUBJIDASEQBRTHDTTRT01PITTFLHEIGHTVWEIGHTVBSAACEINHFLPARAMPARAMCDPARAMNAVALAVISITAVISITNVISITADTABLFLBASECHGPCHGCHGCAT1SRCDOMSRCSEQ
1DMD-EFLGEDMD-EFLGE-101115FEB2013Treatment AY119201.09YLeft Ventricular Ejection Fraction, Calculated (%)LVEFC167Visit 1 (Baseline)1VISIT 116MAY2022Y67


CV3
2DMD-EFLGEDMD-EFLGE-101215FEB2013Treatment AY119201.09YRight Ventricular Ejection Fraction, Calculated (%)RVEFC274Visit 1 (Baseline))1VISIT 116MAY2022Y74


CV7
3DMD-EFLGEDMD-EFLGE-101315FEB2013Treatment AY119201.09YN-Terminal ProB-type Natriuretic Peptide (IU/L)BNPPRONT340Visit 1 (Baseline)1VISIT 116MAY2022Y40


LB1
4DMD-EFLGEDMD-EFLGE-101415FEB2013Treatment AY132321.33YLeft Ventricular Ejection Fraction, Calculated (%)LVEFC160Visit 6 (1 Year)6VISIT 606APR2023
67-7-10.447761Decline >=10.0CV11
5DMD-EFLGEDMD-EFLGE-101515FEB2013Treatment AY132321.33YRight Ventricular Ejection Fraction, Calculated (%)RVEFC261Visit 6 (1 Year)6VISIT 606APR2023
74-13-17.567568Decline >=10.0CV15
6DMD-EFLGEDMD-EFLGE-101615FEB2013Treatment AY132321.33YN-Terminal ProB-type Natriuretic Peptide (IU/L)BNPPRONT3900Visit 6 (1 Year)6VISIT 106APR2023
408602,150
LB2

ADCVCMR Analysis Dataset

Example 2

The dataset above can also be set up to provide multivariate analyses by taking the lab tests of interest, transposing and merging with the ADCVNTP dataset. In that case, the records from LB are not needed as a row. The stratification variables such as BSA and ACEINHFL are carried over, but not HEIGHTW or WEIGHTW which were used to compute BSA values.

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Display

Table 14.xx.xx Percent Change in Left Ventricular Ejection Fraction Percent Over Time (Yearly)

Analysis ResultComparison of Percent Change of Ejection Fraction for the Treatment Groups Over Time ( yearly)
Analysis Variables(s)CHG
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.)

/* Note that CHG is only computed post-baseline, so subset for the yearly visits, i.e. 6, 12, 18 etc. */

DATA TWO;

SET ADCVCMR;

/* 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 = "LVEFC"; 

RUN;


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;


Table 3.  This  This example uses the dataset ADCVNTP, selecting for the parameter "N-Terminal ProB-type Natriuretic Peptide (IU/L)".

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