-
-
Notifications
You must be signed in to change notification settings - Fork 10
Open
Labels
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:
Creator: anajens