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 2 Timing of side effects reported by participants (N = 19*)

AE	N	When experienced^† (n)
AE	N	At treatment initiation	During titration	Maintenance
Headache	15	7	11	7
Jaw pain	12	5	7	9
Nausea	10	4	5	5
Diarrhea	7	4	3	5
Muscle pain	6	2	4	5
Flushing (blushing, blotchiness)	6	4	2	3
Pain in the extremities	5	4	5	1
Joint pain	3	0	1	1
Nasopharyngitis (cold symptoms)	3	3	0	1
Vomiting	2	0	1	1
Back pain	2	0	0	1
Sensitivity to sunlight	1	0	0	1
Fatigue	1	1	1	0
Heart palpitations/ racing heart	1	0	1	0
Insomnia	1	0	0	1
Dry mouth and eyes/ feeling dehydrated	1	1	1	1

AE: adverse event; PAH: pulmonary arterial hypertension
Note: In some cases, participants reported experiencing a side effect during multiple periods or failed to answer a follow-up question, so counts in each section do not always sum to the number reporting a given side effect. Concepts listed in italics were spontaneously reported by a single participant each, but they were not included in the interview guide and therefore were not probed with all participants
*One participant is not included in this table because she reported experiencing a wide variety of side effects (headache, nasopharyngitis, nausea, flushing, diarrhea, dry heaving, numbness in hand/arm, gas/belching) but stated there was no way she could determine the cause of any of them because she had been on three medications simultaneously for the duration of her PAH treatment
^†“At treatment initiation” represents reports of the side effect starting right away or very soon after initiating treatment with selexipag. “During titration” includes participants who reported the side effect started at some point during the titration period. This includes participants for whom the side effect continued steadily after it began, and those for whom the side effect started or worsened with each dosage increase and leveled out until the next increase. “Maintenance” includes participants who reported experiencing the side effect when they were on a stable maintenance dosage of selexipag