Bioequivalence and Bioavailability Forum

Dear Such,

❝ 1) will the mild episode have a stop date and 'outcome' as resolved and

❝ moderate is captured with the same start date as stop date of milder

❝ version

No. You can't consider it as resolved: the adverse event was still there, and it worsened.

❝ 2) only stop date is captured and 'outcome' as not resolved and moderate

❝ episode on other page

Again not. It didn't stop.

❝ 3) Neither stop date nor outcome is captured and moderate episode is

❝ captured on other page in continuation to mild one.

Mother Nature hates emptiness. Competent Authorities hate empty fields.

❝ At our place as per Data Management team consider these as two different

❝ events and is saying that it is in accordance with industrial practice

❝ worldwide

Let's imagine your patient had a headache, first mild (at 09:15), later moderate (at 11:30, resolved at 17:30). The adverse event is "headache", not "mild" or "moderate" ! This is one single event, "headache". It started at 09:15 and was resolved at 17:30, and was of moderate intensity. Full stop.

Most adverse events are mild in severity for at least the first minutes when they appear ! Do your data management people really intend to declare each AE twice ?

Same thing for serious adverse events. Let's imagine one subject had a severe diarrhoea for several days, got dehydrated and had to be hospitalised after 3 days. Will your data management people declare the AE twice, first as non-serious, then as serious after he was hospitalised ? No, this is just one single event, "diarrhoea" (and not "hospitalisation", by the way ! This is a common mistake. The hospitalisation is what changed the AE into a SAE, it is not the AE itself. The SAE is what caused the hospitalisation). Start date for this SAE would be the date of the first loose stool, not the date the subject was hospitalised, even though it was not serious initially.

Regards
Ohlbe