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Table 3 Adverse events and serious adverse events

From: Cytokine clearance with CytoSorb® during cardiac surgery: a pilot randomized controlled trial

 

Control

(n = 15)

CytoSorb

(n = 15)

p value

Total adverse events

30

23

 

 Fatal adverse events

2

1

 

Patients with fatal adverse event—no. (%)

2 (13.3)

1 (6.7)

1.00

Patients with severe non-fatal adverse event—no. (%)

8 (53.3)

8 (53.3)

1.00

Patients with at least 1 adverse event—no. (%)

10 (66.7)

11 (73.3)

1.00

Adverse events categories

 Respiratory—no. (%)

0 (0)

2 (13.3)

0.48

 Cardiogenic shock—no. (%)

0 (0)

1 (6.7)

1.00

 Haemorrhagic shock—no. (%)

0 (0)

1 (6.7)

1.00

 Distributive shock—no. (%)

2 (13.3)

1 (6.7)

1.00

 Arrhythmias—no. (%)

8 (53.3)

5 (33.3)

0.46

 Surgical complications—no. (%)

4 (26.7)

4 (26.7)

1.00

 Infection—no. (%)

4 (26.7)

1 (6.7)

0.33

 Acute liver failure—no. (%)

0 (0)

1 (6.7)

1.00

 Acute kidney injury—no. (%)

4 (26.7)

4 (26.7)

1.00

 Neurological AE (including stroke)—no. (%)

3 (20.0)

2 (13.3)

1.00

 Electrolyte disorders—no. (%)

1 (6.7)

0 (0)

1.00

  1. All adverse events documented in the first 28 days following the randomisation were recorded. All patients who died were analysed and classified as fatal serious events. Patients were counted once for each event category even if they had multiple events in that category. Comparisons were made by Fisher’s exact test