If the first report is late or incomplete, Day 0, case validity, and everything after them work from delayed or missing data. These notes keep the published figures, the limits on them, and what happens when a report is never started or is started late.
These are literature and regulatory figures, not AE Connect measurements. Spontaneous-report totals are not incidence rates. A reported outcome is not proof that a medicine caused the event. AE Connect does not submit or transmit ICSRs, and these notes do not claim that the software changes mortality.
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Underreporting facts · 28 October 2026
Six facts, with the limits attached
Six published figures. Each one has a limit printed on the card. These are literature and regulatory figures, not AE Connect measurements.
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Root causes · 28 October 2026
Why many reactions never become a report
A 2023 update asked why healthcare professionals do not report. Knowledge and attitudes still dominated. The percentages are the share of studies that name a factor, not an official rate.
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Late intake · 28 October 2026
What late intake does to the work after it
When intake is late, coding, medical review, an E2B file, and signal statistics start late. When the minimum criteria are never collected, they never see a valid case.
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Education · 28 October 2026
Education on reporting and intake
AE Connect commits to public education on adverse-event reporting and on case intake. That work is funded with a dedicated education and awareness budget.
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Mission · 28 October 2026
AE Connect’s mission
Medicines are built to save and improve lives. AE Connect’s mission is to catch adverse drug reactions before it is too late.
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Agreements · 28 October 2026
Pharmacovigilance agreements (PVA / SDEA) and partner AE intake
PVA means pharmacovigilance agreement, not software. The note is adverse event exchange and partner ICSR intake under that agreement.