Table 9.
Ponatinib dose modifications following non-adjudicated and adjudicated arterial occlusive events (AOEs)a
| 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| Drug interrupted + drug withdrawn | 0 | 2 (3) | 0 | 2 (3) |
| Drug withdrawn | 17 (15) | 5 (6) | 16 (18) | 5 (7) |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) |
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modification was derived as the most severe one across all events with the following severity order (high to low): drug withdrawn, drug reduced plus drug interrupted, drug reduced only, drug interrupted only, no dose modification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