Table 5 Characteristics of patients with TEEs that were deemed possibly or probably related to study drug
Patient | TEE | Age Sex Race BMI | Total dose Max. infusion speed No. of infusion episodes Active infusion time | Time from start of last IVIg infusion to diagnosis of TEE (days) | Global disease activity | Risk factors for TEEs |
|---|---|---|---|---|---|---|
Patient 2 | DVT; severe | 67 years Male White race 26.0 kg/m2 | 180 g; 1.978 g/kg 0.12 mL/kg/min Two infusion episodes infused over 340 min | 2 | Moderate | • Hypertension • Chronic heart failure • Dyslipidaemia • Ex-smoker |
PE; severe | 2 | |||||
Patient 3 | Cerebrovascular accident (TEE) | 79 years Female White race 28.0 kg/m2 | 160 g; 2.025 g/kg 0.08 mL/kg/min Four infusion episodes; infused over 555 min | 29 | Moderate | • Hypertension • Palpitations • Myocardial ischaemia • Dyslipidaemia |
Patient 4 | PE; moderate | 62 years Male White race 28.7 kg/m2 | 180 g; 1.978 g/kg 0.04 mL/kg/mina Two infusion episodes infused over 590 min | 24 | Moderate | • Hypertension • Ventricular dilatation and left atrial dilatation • Obesity |
Patient 6 | Cerebral infarction; moderate | 70 years Female White race 22.5 kg/m2 | 110 g; 2.000 g/kg 0.12 mL/kg/min Three infusion episodes infused over 321 min | 14 | Mild | • Hypertension |
Patient 7 | Hypoaesthesia; mild | 67 years Female White race 35.3 kg/m2 | 170 g; 2.000 g/kg 0.04 mL/kg/min Two infusion episodes infused over 592 min | 10 | Severe | • Supraventricular arrhythmia • Hypercholesterolaemia • Osteoporosis of the lumbar spine and fractures of the thoracic and lumbar spine • Obesity |