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

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

  Any AOE Serious AOE
Non-adjudicatedb
(n = 111)
Adjudicatedc
(n = 78)
Non-adjudicatedb
(n = 90)
Adjudicatedc
(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Drug interrupted + drug withdrawn 0 2 (3) 0 2 (3)
Drug withdrawn 17 (15) 5 (6) 16 (18) 5 (7)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)
  1. Data are no. (%) of patients with an AOE
  2. MedDRA Medical Dictionary for Regulatory Activities
  3. 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modification was derived as the most severe one across all events with the following severity order (high to low): drug withdrawn, drug reduced plus drug interrupted, drug reduced only, drug interrupted only, no dose modification
  4. bCategorization of AOEs is based on MedDRA preferred terms related to vascular ischemia or thrombosis
  5. cEvents adjudicated as AOEs by the cardiovascular endpoint Adjudication Committee