Quantitative Methods 2017

• 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 Acute salivary gland necrosis; severe secretion-induced

Life-threatening consequences; urgent intervention indicated

symptoms (e.g., thick saliva/oral secretions or gagging); tube feeding or TPN indicated; limiting self care ADL; disabling

indicated; secretion- induced symptoms; limiting instrumental ADL