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Endpoints that include different toxicity states in one

endpoint

EXAMPLE: CTCAEv4.0 Salivary duct inflammation

Composed endpoints

Grade 1

Grade 2

Grade 3

Grade 4

Slightly thickened

saliva; slightly

altered taste (e.g.,

metallic)

Thick, ropy, sticky

saliva; markedly

altered taste;

alteration in diet

indicated; secretion-

induced symptoms;

limiting instrumental

ADL

Acute salivary gland

necrosis; severe

secretion-induced

symptoms (e.g.,

thick saliva/oral

secretions or

gagging); tube

feeding or TPN

indicated; limiting

self care ADL;

disabling

Life-threatening

consequences;

urgent intervention

indicated