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Table 3 Adverse events by severity, relationship to drug, and action taken

From: A phase I, placebo-controlled, randomized, double-blind, single ascending dose-ranging study to evaluate the safety and tolerability of a novel biophysical bronchodilator (S-1226) administered by nebulization in healthy volunteers

 

S-1226 (4 % CO2) (n = 9)

S-1226 (8 % CO2) (n = 9)

S-1226 (12 % CO2) (n = 9)

Placebo (n = 9)

Total (n = 36)

Severity

     

 Mild

3

1

20

4

28

 Moderate

0

0

0

0

0

 Severe

0

0

0

0

0

Relationship to drug

     

 Probable

0

0

0

0

0

 Possible

1

0

6

0

7

 Remote

1

1

3

1

6

 Unrelated

1

0

11

3

15

Action taken

     

 Dose increased

0

0

0

0

0

 Dose not changed

3

1

18

2

24

 Dose reduced

0

0

0

0

0

 Drug interrupted

0

0

1

0

1

 Drug withdrawn

0

0

0

0

0

 Not applicable

0

0

1

0

3

 Unknown

0

0

0

0

0