Gynae BT 2017

Morbidity assessment in clinical trials (Kirchheiner)

Anemia defined as reduction in the amount of hemoglobin in 100 ml of blood.

Analytic outcomes (lab / imaging)

objective subjective

Physician assessed objective symptoms

Atrophy of the vaginal mucosa, ulceration, necrosis, fistula

Number of stools / day, consistency of stool

Patient reported objective symptoms

Fatigue, pain, sexual functioning problems

Patient reported subjective symptoms

Patient reported impact of symptoms on ADL

Impact of difficulties controlling bowel on activities of daily life / quality of life

Patient reported complex multidimensional concepts

Health-related quality of life, functioning aspects in daily life, psychological status

clinical decision / medical intervention