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:

  1. 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.

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  2. Lol Moose, that is so true.

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

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  4. 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.

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  5. Really serious = "super duper untoward..."

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

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  7. Slow and painful death, with lots of screaming.

    Chronic agonising pain, but no death.

    Banging your elbow on that spot where it really hurts.

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  8. 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".

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

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

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So wadda you think?