•
Endpoints that include different toxicity states in one
endpoint
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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