insightsengineering / insightsengineering/random.cdisc.data

Add additional parameters to ADEX

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enhancement New sme SP5
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Description

Pick up issue after #166 is complete.

Please add to ADEX the parameters from the table below. Assume PARCAT2 = OVERALL unless noted otherwise. For OVERALL parameters, number of records (within PARCAT2) should equal number of subjects in corresponding arm.

PARAM | PARAMCD | Comments
-- | -- | --
Study drug duration during constant dosing interval (days) | DURD | PARCAT1 = INDIVIDUAL
Overall duration (days) | TDURD | Please define AVALCAT1 for this parameter with some categories that make sense given how the data is generated.. For example:0 - <30;30 - <60;60 - <90;90 - <120;>=120
Total number of doses administered | TNDOSE |  
Total dose administered | TDOSE | For PLACEBO records, set AVAL = 0
Overall dose intensity | TDOSINT | For PLACEBO records, set AVAL = 0
Total number of missed doses during study | TNDOSMIS |  
Dose adjusted during study | TADJ | Set AVALC  to Y, N; Should be Y ~ 10% of subjects in corresponding armSet AVAL to 1 for Y, 0 for N
Dose adjusted during study due to AE | TADJAE | Set AVALC  to Y, N; Should be Y ~ 5% of subjects in corresponding armSet AVAL to 1 for Y, 0 for N
Dose adjusted during study due to medication error | TADJME | Set AVALC  to Y, N; Should be Y ~ 1% of subjects in corresponding armSet AVAL to 1 for Y, 0 for N

Provenance:
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Creator: anajens
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