Page 59 - Abbott

Table 13. Serious Adverse Events Over Part 1 and Part 2

Part 1 Part 2
Treatment Control All Patients All Patients
(270) (280) (550) (347)
Subjects Events Subjects Events Subjects Events Subjects Events
Chest pain (non-cardiac) 2 2 4 7 6 9 0 0
Fever 1 1 3 3 4 4 2 2
General malaise 3 3 0 0 3 3 1 1
Death 1 1 1 1 2 2 7 7
Pain 2 2 0 0 2 2 0 0
Sudden cardiac death 1 1 1 1 2 2 1 1
Anasarca 0 0 1 1 1 1 0 0
Central line complication 1 2 0 0 1 2 0 0
Chest discomfort 0 0 1 1 1 1 0 0
Chest pain aggravated 0 0 1 1 1 1 0 0
Chronic fatigue 0 0 1 1 1 1 0 0
Edema of lower extremities 1 2 0 0 1 2 2 2
Fatigue 1 1 0 0 1 1 0 0
Fatigue extreme 1 1 0 0 1 1 0 0
Febrile reaction 0 0 1 1 1 1 0 0
Fever of unknown origin 0 0 1 1 1 1 1 1
Infusion site bleeding 0 0 1 1 1 1 0 0
Multi-organ failure 0 0 1 1 1 1 0 0
Non-cardiac chest pain 0 0 1 1 1 1 1 1
Substernal chest pain 0 0 1 1 1 1 0 0
Sudden death 1 1 0 0 1 1 0 0
Swelling 1 1 0 0 1 1 0 0
Edema 0 0 0 0 0 0 1 1
Malaise 0 0 0 0 0 0 1 1
Organ failure 0 0 0 0 0 0 1 1
Thrombus in catheter 0 0 0 0 0 0 1 1
Ulcer 0 0 0 0 0 0 1 1
Vascular disorders 33 42 27 28 60 70 15 15
(12.2%) (9.6%) (10.9%) (4.3%)
Hypotension 15 20 13 14 28 34 6 6
Hematoma 2 2 2 2 4 4 0 0
Orthostatic hypotension 2 2 2 2 4 4 0 0
Deep vein thrombosis leg 3 4 0 0 3 4 0 0
Low output state 3 3 0 0 3 3 0 0
Peripheral arterial disease 2 2 1 1 3 3 0 0
Claudication 2 2 0 0 2 2 1 1
DVT of legs 2 2 0 0 2 2 0 0
Aortic stenosis 0 0 1 1 1 1 0 0
Arterial thrombosis (limbs) 1 1 0 0 1 1 0 0
DVT 0 0 1 1 1 1 1 1
Deep vein thrombosis 0 0 1 1 1 1 0 0
Extremity necrosis 0 0 1 1 1 1 0 0
Hemorrhage, unspecified 1 1 0 0 1 1 0 0
Hemorrhagic shock 1 1 0 0 1 1 0 0
Hypertension 0 0 1 1 1 1 1 1
Hypovolemic shock 1 1 0 0 1 1 2 2
Labile blood pressure 0 0 1 1 1 1 0 0
Peripheral vascular disease 0 0 1 1 1 1 0 0
Shock hemorrhagic 0 0 1 1 1 1 0 0
Subclavian artery thrombosis 1 1 0 0 1 1 0 0
Thromboembolic event 0 0 1 1 1 1 0 0
Bleeding 0 0 0 0 0 0 1 1
Cardiovascular collapse 0 0 0 0 0 0 1 1
Hypertensive emergency 0 0 0 0 0 0 1 1

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