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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
The text was updated successfully, but these errors were encountered:
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.
Provenance:
The text was updated successfully, but these errors were encountered: