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Table 4 Occurrence of adverse events (AE) agreed upon at the clinical trial research meeting and results of statistical analysis

From: Clinical evaluation of a newly developed automated hemodialysis system as a clinical trial

 

Test/control machine*1

No. of events

Incidence (%)

No. patients with AE

Statistical test

Significant difference

Decrease in blood pressure

Test

24

6.897

12

χ2 = 0.165

P = 0.684

NS

Control

26

7.493

14

Residual blood

Test

3

0.862

1

χ2 = 3.004

P = 0.125

NS

Control

0

0.000

0

Water removal error

Test

6

1.724

6

χ2 = 2.295

P = 0.130

NS

Control

11

3.170

7

  1. *1No. of dialyses are 348 (test machine) and 347 (control machine)