Table 3 Summary of adverse events in safety population

Number of patients, n (%)

 Any adverse events

42 (77.8%)

34 (63.0%)

 Main AEs

  Hypokalemia

3 (5.6%)

2 (3.7%)

  Abnormal liver function

3 (5.6%)

1 (1.9%)

  Upper respiratory infection

3 (5.6%)

3 (5.6%)

  Elevated C-reactive protein

2 (3.7%)

4 (7.4%)

  Elevated blood pressure

2 (3.7%)

2 (3.7%)

  Cough

2 (3.7%)

2 (3.7%)

  Phlegm-retention

3 (5.6%)

0 (0.0%)

  Wheezing

4 (7.4%)

0 (0.0%)

  Agrypnia

2 (3.7%)

2 (3.7%)

 Any severe adverse events

7 (13.0%)

2 (3.7%)

  Abnormal liver function

1 (1.9%)

0 (0.0%)

  Infection (lung, upper respiratory)

3 (5.6%)

0 (0.0%)

  Bacterial infection

1 (1.9%)

0 (0.0%)

  Pulmonary inflammation

0 (0.0%)

1 (1.9%)

  Wheezing

2 (3.7%)

0 (0.0%)

  Ileus

0 (0.0%)

1 (1.9%)

 Any device-related adverse events

3 (5.6%)

2 (3.7%)

 Any adverse events leading to withdrawal

2 (3.7%)

2 (3.7%)

Number of events, n

 Any adverse events

82

63

 An severe adverse event

7

2

 Any device-related adverse events

3

3

Upper respiratory tract infection

31(14.69)

26(20.31)