Definitions and difference in PVG terms: Designated medical event (DME), Important medical events (IMEs), WHO critical terms and AESIs

Designated medical event (DME):

Examples of DMEs include:

So DMEs (things to remember):

Important medical event (IME):

Difference between DME and IME:

DMEs vs IMEs in a nutshell:

  • DMEs would lead to signal even if 2–3 events, not IMEs

Critical terms:

  • Examples: Death, anaphylactic shock, convulsions, erythema multiforme

Adverse event of special interest (AESI):

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Aditi Sheth

Aditi Sheth

MBBS, Aggregate reports manager based in Bangalore, India, Decent and ambitious, curious reader