Skip to content

Add additional parameters to ADEX #15

@cicdguy

Description

@cicdguy

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:

Creator: anajens

Metadata

Metadata

Assignees

No one assigned

    Labels

    Type

    No type

    Projects

    No projects

    Milestone

    No milestone

    Relationships

    None yet

    Development

    No branches or pull requests

    Issue actions