Need Guidance: AEOUT for Split AEs When Severity Increases

amiteshm — Mon, 16 Jun 2025 04:38:08 GMT

Hi everyone,

I'm working on SDTM AE data, and we have a case where a single adverse event (e.g., headache) increases in severity and later becomes serious. As per CDISC and FDA guidance, we're splitting this into multiple AE records using AELINKID.

The issue we're debating is what to use for AEOUT in the intermediate records. Technically, the AE isn't "recovered" at that point — it's just getting worse. But if we set AEOUT = "Not recovered/Not resolved" and still provide an AEENDTC, it triggers FDA validation rule SD1332, which flags this combination as invalid.

So the question is:

How should we populate AEOUT in intermediate split records when the AE hasn't truly resolved, but we need to avoid the SD1332 validation error?

Are we supposed to use "Recovered/Resolved" just to avoid the rule, even if clinically it feels inaccurate?

Appreciate any thoughts or examples of how others are handling this.

Re: Need Guidance: AEOUT for Split AEs When Severity Increases

cherryblossom — Mon, 16 Jun 2025 14:09:10 GMT

Please check internally if you can mention about episodic nature of event and hence AEOUT value is "not recovered" and as the nature is episodic AEENDTC becomes not applicable.

topic Re: Need Guidance: AEOUT for Split AEs When Severity Increases in SAS Programming

Need Guidance: AEOUT for Split AEs When Severity Increases

Re: Need Guidance: AEOUT for Split AEs When Severity Increases