TX Domain Warning: "Invalid value for TXVAL for TRTDOS" when TRTDOS = 0

Pinnacle 21 Support SEND
1

Hi Adam,

This rule was updated just after release of 2304.3 engine. New upcoming Community engine 2405.2 will not report “0” value as an issue.

Sorry for inconvenience.

Kind Regards,
Sergiy

2

While validating SEND Datasets with Pinnacle 21 Community v4.1.0 and FDA Engine 2304.3, there is a warning for “Invalid value for TXVAL for TRTDOS” (SE2366) that is triggered by a TRTDOS value of “0” for our control group SET. This has been our practice to use “0” to represent the treatment dose for the control group and has not given a warning before. We consider “0” numerical which falls within the confines of the rule. Is there any reason this is being flagged by Pinnacle now?