Retrospective analysis of arterial occlusive events in the PACE trial by an independent adjudication committee

Table 9 Ponatinib dose modifications following non-adjudicated and adjudicated arterial occlusive events (AOEs)^a

	Any AOE		Serious AOE
	Non-adjudicated^b (n = 111)	Adjudicated^c (n = 78)	Non-adjudicated^b (n = 90)	Adjudicated^c (n = 74)
No dose modification	46 (41)	36 (46)	28 (31)	31 (42)
Drug interrupted only	37 (33)	25 (32)	37 (41)	26 (35)
Dose reduced only	6 (5)	0	5 (6)	0
Dose reduced + drug interrupted	5 (5)	2 (3)	4 (4)	2 (3)
Drug interrupted + drug withdrawn	0	2 (3)	0	2 (3)
Drug withdrawn	17 (15)	5 (6)	16 (18)	5 (7)
Not applicable/unknown	0	8 (10)	0	8 (11)

Data are no. (%) of patients with an AOE
MedDRA Medical Dictionary for Regulatory Activities
^aWhen a patient had multiple events, dose modification was derived as the most severe one across all events with the following severity order (high to low): drug withdrawn, drug reduced plus drug interrupted, drug reduced only, drug interrupted only, no dose modification
^bCategorization of AOEs is based on MedDRA preferred terms related to vascular ischemia or thrombosis
^cEvents adjudicated as AOEs by the cardiovascular endpoint Adjudication Committee

ISSN: 1756-8722