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Table 6 Risk factors for TEEs in patients who did not present with TEEs versus those who presented with TEEs (overall period)

From: Safety and tolerability of intravenous immunoglobulin in patients with active dermatomyositis: results from the randomised, placebo-controlled ProDERM study

 

No. of TEE (N = 89)

TEE (N = 6)

Age, mean (range), years

51.6 (22–77)

69.0 (62–79)

Gender, n (%) female

68 (76.4)

3 (50)

Race, n (%)

 Asian

2 (2.2)

0 (0)

 Black or African American

5 (5.6)

0 (0)

 White

81 (91.0)

6 (100)

 Other

1 (1.1)

0 (0)

TEE risk factors

 Hypertension, n (%)

31 (34.8)

5 (83.3)

 Chronic heart failure, n (%)

1 (1.1)

1 (16.7)

 Myocardial ischaemia, n (%)

2 (2.2)

1 (16.7)

 Dyslipidaemia, n (%)

4 (4.5)

2 (33.3)

 Dilation ventricular and left atrial dilation, n (%)

1 (1.1)

1 (16.7)

 Obesity, n (%)

3 (3.4)

2 (33.3)

 Supraventricular arrhythmia, n (%)

0 (0.0)

1 (16.7)

 Hypercholesterolaemia, n (%)

8 (9.0)

2 (33.3)

 Osteoporotic fracture, n (%)

1 (1.1)

1 (16.7)

No. of TEE risk factors per patient

 0 risk factors

50 (56.2)

0 (0)

 1 risk factor

28 (31.5)

1 (16.7)

 2 risk factors

10 (11.2)

0 (0)

 3 risk factors

1 (1.1)

5 (83.3)

Physician global disease activity (actual), n (%)

 Mild

24 (27.0)

2 (33.3)

 Moderate

52 (58.4)

4 (66.7)

 Severe

13 (14.6)

0 (0.0)

Maximum infusion rate per patient, median (range), mL/kg/min

 Pre-introduction of lower infusion rate

0.12 (0.04–0.12)

0.12 (0.04–0.12)

 Following introduction of lower infusion rate

0.04 (0.02–0.08)

0.04 (0.02–0.08)

 Actual IVIg dose, median (range), g/kg

1.99 (0.24–2.03)

1.99 (1.98–2.03)

  1. IVIg intravenous immunoglobulin, TEE thromboembolic event