A multi-method approach to selecting PRO-CTCAE symptoms for patient-reported outcome in women with endometrial or ovarian cancer undergoing chemotherapy

Journal of Patient-Reported Outcomes

Table 1 Core outcome set and corresponding PRO-CTCAE items

MedDRA system organ classes¹	Core outcome sets^2,3	Corresponding PRO-CTCAE items⁴
Gastrointestinal disorders	➝
	Constipation²	Constipation
	Diarrhea²	Diarrhea
	Nausea²	Nausea
	Bloating³	Bloating
	Vomiting³	Vomiting
	Cramping³	Bloating/abdominal pain
	Indigestion³	Diarrhea, constipation, abdominal pain
General disorders and administration site conditions	➝
	Pain²	Abdominal pain
	Abdominal pain³	Abdominal pain
	Fatigue²	Fatigue
Metabolism and nutrition disorders	➝
	Anorexia (appetite loss)²	Decreased appetite
	Weight gain³	N/A
	Weight loss³	Decreased appetite
Nervous system disorders	➝
	Sensory neuropathy²	Numbness & tingling
Psychiatric disorders	➝
	Anxiety (includes worry)²	Anxious
	Cognitive problems²	Concentration, memory
	Depression (includes sadness)²	Discouraged, sad
	Fear of recurrence/disease progression³	N/A
	Insomnia²	Insomnia
Reproductive system and breast disorders	➝
	Sexual dysfunction³	Decreased libido
		Vaginal dryness
Respiratory, thoracic, and mediastinal disorders	➝
	Dyspnea²	Shortness of breath
Unique symptoms in total	21	18

MedDRA Medical Dictionary for Regulatory Activities, PRO-CTCAE Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events
¹Medical Dictionary for Regulatory Activities (MEDDRA) [Internet]. Available from: https://www.meddra.org/ [39], ²Reeve et al. [41], ³Donovan et al. [42],⁴PRO-CTCAE. PRO-CTCAE® Measurement System website [Internet]. Available from: https://healthcaredelivery.cancer.gov/pro-ctcae [17]