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Add additional parameters to ADEX #15

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cicdguy opened this issue Aug 5, 2021 · 0 comments
Open

Add additional parameters to ADEX #15

cicdguy opened this issue Aug 5, 2021 · 0 comments
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enhancement New feature or request New sme SP5

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@cicdguy
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cicdguy commented Aug 5, 2021

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

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Creator: anajens
@cicdguy cicdguy added enhancement New feature or request New SP5 labels Aug 5, 2021
@shajoezhu shajoezhu added the sme label Apr 29, 2022
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