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Table 3 Definitions of severity

From: PANasta Trial; Cattell Warren versus Blumgart techniques of panreatico-jejunostomy following pancreato-duodenectomy: Study protocol for a randomized controlled trial

Definition of severity of adverse event

Grade

Description

1. Mild

Grade 1

Does not interfere with patient’s usual function (awareness of symptoms or signs, but easily tolerated (acceptable)

2. Moderate

Grade 2

Interferes to some extent with patient’s usual function (enough discomfort to interfere with usual activity (disturbing)

3. Severe

Grade 3

Interferes significantly with patient’s usual function (incapacity to work or to do usual activities (unacceptable)

4. Life-threatening

Grade 4

Results in risk of death, organ damage, or permanent disability (unacceptable)

5. Death

Grade 5

Results in death (unacceptable)