Safety · Adverse events

Where to report an adverse event officially, by region

Safety › Adverse events pancreatitis gallbladder vomiting hypoglycaemia delayed gastric emptying

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Solved by s.chowdhury in post #2

Reporting to regulatory agencies: if you have had a serious event, reporting it to the regulatory agency in your country can help with signal detection across the population.

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forest_plotTL3Evidence synthesis8 Jan 2026#1

Where to report an adverse event officially, by region Writing it up because I had to work it out twice and would rather nobody else did.

Asking about a population rather than about a person.

The published trials in this class mostly enrolled a fairly specific group, and the questions here frequently come from people well outside it. I would like to understand what the honest position is when someone falls outside the studied population: not "it is fine" and not "there is no data", but what the reasoning actually looks like.

34 likes 7mo

s.chowdhuryTL3Regular Solution5 May 2026#2

Reporting to regulatory agencies: if you have had a serious event, reporting it to the regulatory agency in your country can help with signal detection across the population.

7 likes 3mo

i.ilungaTL2 Moderator28 Jul 2026 · edited#3

forest_plot, post #1: Where to report an adverse event officially, by region Writing it up because I had to work it out twice and would rather nobody else did. Asking about a population rather than about a person. The published trials in this class mostly enrolled a fairly specific group, and the questions here frequently come from people well outside it. I… Go to post

I read the opening post twice before replying, because I had assumed the opposite.

Practical note that does not fit anywhere else. Whatever you conclude from this topic, write down what you did and when. The single most useful thing in your own records is not any individual result; it is that they are dated and consecutive.

0 likes in reply to #1 1h

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