myCSG © |Area: ADaM| Concept: C1005 : ADaM BDS - Derived records creation | Lesson: L101a : Creation of new records to hold the maximum value across postbaseline record |

  • Let us say we have a TFL shell which summarizes the result and change from baseline at each visit and 'maximum value postbaseline'  as shown in the screenshot below.

 

  Treatment 1
  Result Change from Baseline
  n Mean SD n Mean SD
Baseline xx xx.x xx.xx xx xx.x xx.xx
Week 2 xx xx.x xx.xx xx xx.x xx.xx
Week 4 xx xx.x xx.xx xx xx.x xx.xx
Week 8 xx xx.x xx.xx xx xx.x xx.xx
Week 24 xx xx.x xx.xx xx xx.x xx.xx
Maximum value postbaseline xx xx.x xx.xx xx xx.x xx.xx

 

For the derived datasets to be analysis-ready, we need to identify the maximum value observed during postbaseline period. We also need to decide on how to organize the analysis dataset.

 In ADaM implementation guide, there are certain rules that guide a user on when to add an analysis data point as a 'Row' and when to add it as a 'Column'.

Rule 3

A function of one or more rows within the same parameter for the purpose of creating an analysis timepoint should be added as a new row for the same parameter.
  • 'Maximum value postbaseline' is considered as 'conceptual' analysis timepoints in the shell provided to us.
  • So, we need to apply 'Rule 3' for this scenario and add new rows for the same parameter in this scenario.

In this lesson, we will see:

  • How to identify the record with maximum value and append that record to parent dataset
  • Usage of 'DTYPE' variable to identify the derived records.
 
VARIABLE_NAMEVARIABLE_LABELDERIVATION
ADT Analysis Date Extract the date portion from VSDTC and convert it to numeric value
PARAM Parameter Set to propcase(VSPOS)||VSTEST||" ("||VSSTRESU||")
PARAMCD Parameter Code If VSPOS="SITTING" and VSTESTCD="SYSBP" then set to "STSBP",
Else if VSPOS="SITTING" and vSTESTCD="DIABP" then set to "STDBP"
PARAMN Parameter (N) If PARAMCD="STSBP" then set to 1,
Else if PARAMCD="STDBP" then set to 2.
AVAL Analysis Value Set to VSSTRESN
AVISIT Analysis Visit A. For the souce records:
     If VS.VISIT="SCREEN" then set to "Screening",
     Else set to propcase(VS.VISIT)
B. Create a new record for each parameter within a subject to hold the maximum value across all postbaseline records.
If there exists more than record with maximum value pick the record with earliest date.
     On this newly created record set to "Maximum value postbaseline".
AVISITN Analysis Visit (N) A. For the souce records:
     Set to VS.VISITNUM
B. On the newly created record holding the maximum postbaseline value, set to 99
DTYPE Derivation Type Set to "MAXIMUM" on the newly created record holding the maximum value.
Complete SAS code to generate the output is available for registered users!

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