Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 |
Mild | Moderate | Severe | Life threatening | Death |
Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; no change in baseline age-appropriate behaviour * ; no change in baseline care or monitoring indicated . | Moderate; resulting in minor changes of baseline age-appropriate behaviour * ; requiring minor changes in baseline care or monitoring .* † | Severe; resulting in major changes of baseline age-appropriate behaviour* or non-life-threatening changes in basal physiological processes†; requiring major change in baseline care or monitoring.*‡ | Life threatening; resulting in life-threatening changes in basal physiological processes†; requiring urgent major change in baseline care. | Death related to AE. |
If the different factors of this scale result in conflicting severity grades, the highest grade should be reported. Italics indicate the differences with the adult generic severity criteria of CTCAE.
*Age-appropriate behaviour refers to oral feeding behaviour, voluntary movements and activity, crying pattern, social interactions and perception of pain.
†Basal physiological processes refer to oxygenation, ventilation, tissue perfusion, metabolic stability and organ functioning.
‡Minor care changes constitute: brief, local, non-invasive or symptomatic treatments.
§Major care changes constitute: surgery, addition of long-term treatment, upscaling care level.
CTCAE, Common Terminology Criteria for Adverse Events.