Gynae BT 2017

Physician assessed morbidity Common Toxicity Criteria of AE

Combined information is translated by physician into medical terms and grades

Analytic outcomes (lab / imaging)

objective subjective

Physician assessed objective symptoms

CTCAE v4. Proctitis G2

Symptoms e.g., rectal discomfort, passing blood or mucus; medical intervention indicated;

Patient reported objective symptoms

Patient reported subjective symptoms

limiting instrumental activities of daily life

Patient reported impact of symptoms on ADL

Depends on the interpretation of the physician Translation problems may be assumed!

Patient reported complex multidimensional concepts

clinical decision / medical intervention