Use of the National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events to assess treatment tolerability in pulmonary arterial hypertension: qualitative patient research findings in current and former users of oral selexipag

Journal of Patient-Reported Outcomes

Table 4 Perceived relevance of PRO-CTCAE items (N = 20)

PRO-CTCAE item	No. of participants debriefed on item	Attributes measured*	Relevant	Not relevant	Participants who had personally experienced (N = 19)
Round 1 and Round 2 interviews
Headache	20	F, S, I	20	0	15
Nausea	20	F, S	20	0	10
Loose or watery stools (diarrhea)	20	F, I^†	18	2	7
Aching muscles	20	F, S, I	18	2	6
Aching joints	20	F, S, I	17	3	3
Vomiting	20	F, S	17	3	2
Round 1 interviews only
Pain	10	F, S, I	9	1	5^‡
Cough	10	S, I	7	3	0
Round 2 interviews only
Jaw pain	10	F, S, I	8	2	12^§
Blushing	10	F, S	9	1	6

PRO-CTCAE: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events
*F = frequency; S = severity; I = interference with daily life
^†The interference item was added for the final 10 (Round 2) interviews
^‡Five participants reported “pain in the extremities,” but the PRO-CTCAE item is a general pain item
^§Twelve participants reported jaw pain during concept elicitation, but this item was only presented as an item for debriefing following midpoint revisions, in the final 10 interviews