AET01_ADA [Spec Added]

[crazycatandy]

Table Name

AET01_ADA

Description

Adverse Events by ADA Status Summary Table

Analysis dataset

ADAE

Analysis filtering

ADAE.ANL01FL="Y"

Analysis population

SE

Column Variable

ACTARM

Analysis variables

As AET01, but with header splitting by a variable added to ADSL to indicate ADA status. This should be sourced from ADAB.AVALC where ADAB.PARAMCD="ADASTAT" by the user. Option in template to call different source variable from ADSL, default naming expectation can be ADSL.ADASTAT

Analysis concept

See AET01 - template below shows defaults to use in this specific template

Statistics

As AET01

Default treatment of zero count rows

As AET01

Additional comments

[barnett11]

No defined variable that keeps ADA positivity as reference within standards. We may want to dummy something (eg. ADSL.ADAPOS) and users overwrite with what they have, but approach needs to be determined.

[shajoezhu]

We also had a similar request from earlier this year. I would suggest to resolve these two issue together: i.e. do the design in tmc, and then productionize in chevron. still need to resolve the relavant data issue first

[barnett11]

New specifiation added to derive this template
FYI @crazycatandy @clarkliming