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Questions:

  1. Is screening considered visit 1, or is it to include the subject into the study? SDTM team agreed to change to VISIT 1 instead of SCREENING.
  2. Are these Real World Evidence (RWE) studies only or clinical trials?
  3. Should both endpoints be shown in one efficacy dataset or two? I will be showing 3 datasets.
  4. What is a good surface area to use for the child subject?
  5. Should i use Male and 6 years? please advise.

In this section, example analysis datasets are shown for the following endpoints:

  1. Percent change in ejection fraction for a period of 1 year
  2. Decline in ejection fraction for a period of 1 year, grouped by a decline greater than 10.0%
  3. Percent change in NTproBNP for a period of 1 year

Source Data

The SDTM examples used as the source data are from Section 2.1, Basic CMR Tests - Systolic Function. The CV dataset contains 16 rows, 1-8 for visit 1 and 9-16 for visit 6. Of these rows, the ones where CVTESTCD = "LVEF_C" and "RVEF_C" were used for analysis. In the LB dataset, the records where LBTESTCD = "BNPPRONT" were used to compute the percentage change over time, then added as a potential covariate in each row for the last analysis. The SDTM datasets were merged with a Subject Level Analysis Dataset (ADSL) dataset to record the demographics, treatments and other appropriate variables for analysis.

ADaM Datasets

The tables below show the example analysis datasets and unique parameters for this endpoint. In this example, only some of the required variables, plus important stratification variables from ADSL, are shown for illustrative purposes. For example, body surface area at baseline (BSABL) was computed for baseline records in ADSL. However, since the subjects are children, the body surface area changes over time. Therefore, it would probably be necessary to have a separate dataset to represent this over time.

Analysis Datasets

ADSL Analysis Dataset

The ADSL includes demographics, treatment groups, study dates and stratification variables. For this example, the ADSL is not shown other than as a source for standard ADaM variables. See Section 2.3.1 of the ADaMIG v1.3 for additional information.

ADCVNTP Analysis Dataset

The ADCVNTP dataset is a subset of the Laboratory Results (LB) SDTM dataset, for which LBTESTCD is equal to "BNPPRONT". In this case, many lab draws may be conducted throughout the year, but only those linked to a specific visit are included. By subsetting the LB dataset with LBLNKID not missing, laboratory data that aligns with CV data can be filtered out and sorted using USUBJID and VISIT. If LBLNKID is not available, a windowing strategy could be used to select the laboratory draw closest to that visit for merging with CV, computed in AVISIT.

Parameter Value List - ADCVNTP [ADCVNTP]

The subsequent section provides the data structures for the example ADaM datasets. In this example, columns for derived variables BASE, CHG, PCHG and CHGCAT1 have been added to facilitate analyses of the efficacy endpoints. Specifically, example demographic data for ADSL were created for an 8 year old male. Also, a custom variable for BSA at baseline (BSABASE) was added from ADSL.

ADCVNTP Variable Metadata

Example 1

This example dataset shows the findings and additional analysis variables associated with:

  • Left Ventricular Ejection Fraction, Calculated (%)
  • Right Ventricular Ejection Fraction, Calculated (%)
  • N-Terminal ProB-type Natriuretic Peptide (pg/mL)

Rows 1-2:Show the baseline CMR ejection fraction measurements for participant 101 at VISIT 1.
Row 3:Shows the baseline NTProbTest for participant 101 at VISIT 1.
Rows 4-5:Show the CMR ejection fraction measurements for participant 101 at VISIT 6.
Row 6:Shows the NTProbTest for participant 101 at VISIT 6.
$titleHtml

adcvntp.xpt

RowSTUDYIDUSUBJIDASEQBSABASEPARAMPARAMCDPARAMNAVALAVISITAVISITNVISITADTABLFLBASECHGPCHGCHGCAT1TRT01PITTFLAGEAGEUSEXSRCDOMSRCSEQ
1DMD-EFLGEDMD-EFLGE-10110.65Left Ventricular Ejection Fraction, Calculated (%)LVEFC167Visit 1 (Month 1)1VISIT 116May2022Y67


Treatment AY8YEARSMCV3
2DMD-EFLGEDMD-EFLGE-10120.65Right Ventricular Ejection Fraction, Calculated (%)RVEFC274Visit 1 (Month 1)1VISIT 116May2022Y74


Treatment AY8YEARSMCV7
3DMD-EFLGEDMD-EFLGE-10130.65N-Terminal ProB-type Natriuretic Peptide (IU/L)BNPPRONT340Visit 1 (Baseline)1VISIT 116May2022Y40


Treatment AY8YEARSMLB1
4DMD-EFLGEDMD-EFLGE-10140.65Left Ventricular Ejection Fraction, Calculated (%)LVEFC160Visit 6 (Month 12)6VISIT 601Jun2023
67-7-10.447761Decline >=10.0Treatment AY8YEARSMCV11
5DMD-EFLGEDMD-EFLGE-10150.65Right Ventricular Ejection Fraction, Calculated (%)RVEFC261Visit 6 (Month 12)6VISIT 601Jun2023
74-13-17.567568Decline >=10.0Treatment AY8YEARSMCV15
6DMD-EFLGEDMD-EFLGE-10160.65N-Terminal ProB-type Natriuretic Peptide (IU/L)BNPPRONT3900Visit 6 (Month 12)6VISIT 61Jun2023
408602,150
Treatment AY8YEARSMLB2
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your 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 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)
ADCVNTPCHGPARAMCD = "BNPPRONT"BNPCHGN-Term ProB-type N Pep Change Category

$titleHtml

adcvntp.xpt

RowSTUDYIDUSUBJIDASEQBSABASEBNPPRONTBNPCHGPARAMPARAMCDPARAMNAVALAVISITAVISITNVISITADTABLFLBASECHGPCHGTRT01PITTFLAGEAGEUSEXSRCDOMSRCSEQ
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-10130.659002150Left Ventricular Ejection Fraction, Calculated (%)LVEFC160Visit 6 (Month 12)6VISIT 601JUN2023
67-7-10.447761Treatment AY8YEARSMCV11
4DMD-EFLGEDMD-EFLGE-10140.659002150Right Ventricular Ejection Fraction, Calculated (%)RVEFC261Visit 6 (Month 12)6VISIT 601JUN2023
74-13-17.567568Treatment AY8YEARSMCV15
$warningHtml

ADCVEF Analysis Dataset

The ADCVEF dataset includes tests pertinent to this analysis, those for which CVTESTCD is equal to "LVEF_C" or "RVEF_C". The relationship dataset RELREC illustrates the relationship between datasets. 

ADCVMRI Analysis Dataset

ADCMRI is an efficacy analysis dataset with only a few records for more complex modeling of changes in ejection fraction, plus the ProB-type test results. It is an ADaM Basic Data Structure (BDS) dataset, with additional variables added from ADCVEF.

Example Analysis Results Metadata (ARM) Tables

This is an example ARM table for the selected endpoint. Other endpoints can be represented in the same way describing the variables and procedures used. For more details on ARM, see the ADaMIG and the ARM implementation in Define-XML (available at https://www.cdisc.org/standards/foundational/define-xml/).

Display

Table 14.xx.xx Percent change in NTproBNP over a period of time (yearly)

Analysis ResultComparison of Percent Change of NTproBNP 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 = "BNPPRONT"

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=ADCVNTPR;

WHERE PARAMCD = "BNPPRONT";

CLASS STUYDID TRT01P AVISITN;

MODEL PCHG=AVISITN*TRT01P/Solution;

RANDOM INTERCEPT / SUBJECT=STUYDID TYPE=UN;

LSMEANS TRT01P*AVISITN/ CL PDIFF;

RUN;

Display

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

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;

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