Tuesday, July 29, 2014

Glad they cleared that up

Last night I was at a meeting about an upcoming drug study, and this was one of the slides:



I wanted to ask what they consider REALLY serious.

10 comments:

Moose said...

Hiccups.

Once death happens it's done, right? But hiccups, they're just torture. You never know when they're going to end... or if they'll come back. That's some serious shit there.

Mrs J said...

Lol Moose, that is so true.

lbparker said...

Poison ivy. The gift that keeps on giving and giving and giving. . .

Anonymous said...

This is common terminology in clinical trials. Adverse events (Expected or unexpected) are categorized into two categories: Adverse events and Serious Adverse events. Serious Adverse events includes Grade 3, Grade 4 (hospitalization) and Grade 5 (death) adverse events.
They don't grade adverse events based on oh-not-so serious, maybe serious, serious or really serious.
I love your blog, but this post wasn't post worthy.

Anonymous said...

Really serious = "super duper untoward..."

Anonymous said...

It'd be even better if the subjects self-reported these serious adverse effects, just for the flavor.

DB said...

Slow and painful death, with lots of screaming.

Chronic agonising pain, but no death.

Banging your elbow on that spot where it really hurts.

Anonymous said...

Anonymous (7-29-14)...Actually, the subjects often do report their adverse events. On one clinical trial I worked on, the adverse event was "husband getting out of jail".

cliffintokyo said...

Anonymous at 12:39 is great! LOL!
How about Deadly Adverse Event?
(Certainly, the pharma industry would never accept this one!)

Anonymous said...

In the event of death, please discontinue medication immediately and contact your health care provider.

 
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