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Table 2 Incidence of adverse events in Groups A to H

From: A randomised phase 1 study to investigate safety, pharmacokinetics and impact on gut microbiota following single and multiple oral doses in healthy male subjects of SMT19969, a novel agent for Clostridium difficile infections

  

Number of subjects with adverse events considered possible related to study drug

  

Group and dose of SMT19969

Adverse event

A-H

A

B

C

D

E

F

G

H

Placebo

2 mg

20 mg

100 mg

400 mg

1,000 mg

2,000 mg

200 mg BID

500 mg BID

(N = 14)

(N = 3)

(N = 3)

(N = 6)

(N = 6)

TP1(N = 6)

TP2(N = 6)

(N = 6)

(N = 6)

(N = 6)

Diarrhoea

3

  

1

2

  

1

 

2

Abdominal distension

1

  

1

   

1

  

Abdominal pain

1

      

1

 

1

Duodeno-gastric reflux

       

1

  

Flatulence

1

   

1

     

Dyspepsia

 

1

        

Feeling hot

       

1

  

Paraesthesia

        

1

 
  1. Abbreviations: BID twice daily, N Number of subjects studied, TP Treatment period, Blank cell no AE reported.