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

Fig. 1. CONSORT flow diagram and process for adjudication of arterial occlusive events (AOEs). A CONSORT diagram: Identification of AOEs for review by the adjudication committee. B Adjudication process flow charts. AE adverse event, AC adjudication committee, AIM Applied Clinical Intelligence Information Management System, MedDRA Medical Dictionary for Regulatory Activities, PACE Ponatinib Ph+ ALL and CML Evaluation, PE pulmonary embolism, PVD peripheral vascular disease, VTE venous thromboembolism. aThe Adjudication Committee also reviewed any events included in the Cardiac Failure Standard MedDRA Query (SMQ) to determine whether any heart failure events were AOEs. bAOEs evaluated on the left panel excluded events evaluated in the right panel (stroke, DVT, and PE). cPer the charter, panel meetings were convened to discuss events for which a decision was not reached via independent voting. The quorum for panel meeting attendance was dependent on the type of event(s) to be discussed (i.e., cardiologist, neurologist, or vascular specialist)

Fig. 2. Arterial occlusive event (AOE) rates with ponatinib. A Rates of non-adjudicated and adjudicated AOEs. B Exposure-adjusted incidence of newly occurring arterial occlusive events (AOEs) by year (all patients). Later intervals excluded patients with prior events. Non-adjudicated values were published previously [3]. C Incidence of AOEs (adjudicated) by number of baseline risk factors (all patients). Risk factors included arterial hypertension, hypercholesterolemia, obesity, diabetes mellitus, non-ischemic cardiac disease, and ischemic disease. D Overall survival (OS) in chronic-phase chronic myeloid leukemia (CP-CML) patients with and without AOEs