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 5 Summary of results from the item selection process

MedDRA system organ classes¹	Identified PRO-CTCAE symptoms based on two core outcome sets^2,3	Identified symptoms from product summaries and phase III clinical studies^4,5,6, aligned with matching PRO-CTCAE symptoms⁷	Final PRO-CTCAE symptoms⁷ included in the PRO tool
Gastrointestinal disorders
	Constipation	Constipation	Constipation
	Diarrhea	Diarrhea	Diarrhea
	Nausea	Nausea	Nausea
	Bloating	Mouth/throat sores	Mouth/throat sores
	Vomiting	Vomiting	Vomiting
			Bloating
General disorders and administration site conditions
	Fatigue	Fatigue	Fatigue
	Abdominal pain	General pain	Abdominal pain
Metabolism and nutrition disorders
	Decreased appetite	Decreased appetite	Decreased appetite
Musculoskeletal and connective tissue disorders
		Joint pain	Joint pain
		Muscle pain	Muscle pain
Nervous system disorders
	Numbness & tingling	Numbness & tingling	Numbness & tingling
Psychiatric disorders
	Anxious		Anxious
	Concentration		Concentration
	Discouraged		Discouraged
	Memory		Insomnia
	Insomnia		Memory
	Sad		Sad
Reproductive system and breast disorders
	Sexual dysfunction		Decreased libido
	Vaginal dryness		Vaginal dryness
Respiratory, thoracic and mediastinal disorders
	Shortness of breath	Shortness of breath	Shortness of breath
Skin and subcutaneous tissue disorders
		Hair loss
		Nail loss
		Nail ridging
		Nail discoloration
		Rash
Investigations
		Taste changes
Unique symptoms, total	18	18	21

PRO-CTCAE Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, MedDRA Medical Dictionary for Regulatory Activities
¹Medical Dictionary for Regulatory Activities (MedDRA) [Internet]. Available from: https://www.meddra.org/ (39), ²Reeve et al. [41], ³Donovan et al. [42], ⁴Du Bois et al.[48], ⁵Ozols et al. [47], ⁶Vasey et al. [46], ⁷PRO-CTCAE. PRO-CTCAE® Measurement System website [Internet]. Available from: https://healthcaredelivery.cancer.gov/pro-ctcae/ [17]