Serious adverse event

Got it.

And then it scales to the serious category, an SAE or SAR, serious adverse event or serious adverse reaction.

This isn't just a bad headache.

We're talking about an event that results in death, is immediately life-threatening, requires hospitalization, or causes severe disability.

And the mechanism of action here is speed.

SAEs must be reported to the sponsor immediately.

Practically, the sponsor expects a phone call within 24 hours of the site team becoming aware.

But the highest regulatory alert level, specifically for C-TIMPS, is the SUSAR, right? A suspected, unexpected, serious adverse reaction?