Table 3.

Type and frequency of adverse events



Treatment group*
Adverse event
Placebo
0.025 mg/kg
0.05 mg/kg
0.1 mg/kg
No. subjects   8   5   5   10  
Cardiac disorder: palpitations   0   1 (20.0)   0   0  
Gastrointestinal disorders     
    Abdominal distention   0   1 (20.0)   0   0  
    Abdominal pain   0   1 (20.0)   0   1 (10.0)  
    Constipation   0   1 (20.0)   0   0  
    Diarrhea   0   1 (20.0)   0   0  
    Nausea   0   0   0   2 (20.0)  
General disorders     
    Fatigue   0   1 (20.0)   0   0  
    Thirst   0   0   0   1 (10.0)  
Immune system disorder: drug hypersensitivity   0   1 (20.0)   0   0  
Infection: nasopharyngitis   3 (37.5)   0   0   2 (20.0)  
Injury     
    Head injury   0   0   0   1 (10.0)  
    Joint sprain   0   0   0   1 (10.0)  
    Limb injury   1 (12.5)   0   0   0  
Musculoskeletal disorder: back pain   0   0   0   1 (10.0)  
Nervous system disorders     
    Dizziness   0   0   0   1 (10.0)  
    Headache   1 (12.5)   1 (20.0)   0   3 (30.0)  
    Syncope vasovagal   1 (12.5)   0   0   0  
    Reproductive system disorder:      
    testicular disorder
 
0
 
0
 
0
 
1 (10.0)
 


Treatment group*
Adverse event
Placebo
0.025 mg/kg
0.05 mg/kg
0.1 mg/kg
No. subjects   8   5   5   10  
Cardiac disorder: palpitations   0   1 (20.0)   0   0  
Gastrointestinal disorders     
    Abdominal distention   0   1 (20.0)   0   0  
    Abdominal pain   0   1 (20.0)   0   1 (10.0)  
    Constipation   0   1 (20.0)   0   0  
    Diarrhea   0   1 (20.0)   0   0  
    Nausea   0   0   0   2 (20.0)  
General disorders     
    Fatigue   0   1 (20.0)   0   0  
    Thirst   0   0   0   1 (10.0)  
Immune system disorder: drug hypersensitivity   0   1 (20.0)   0   0  
Infection: nasopharyngitis   3 (37.5)   0   0   2 (20.0)  
Injury     
    Head injury   0   0   0   1 (10.0)  
    Joint sprain   0   0   0   1 (10.0)  
    Limb injury   1 (12.5)   0   0   0  
Musculoskeletal disorder: back pain   0   0   0   1 (10.0)  
Nervous system disorders     
    Dizziness   0   0   0   1 (10.0)  
    Headache   1 (12.5)   1 (20.0)   0   3 (30.0)  
    Syncope vasovagal   1 (12.5)   0   0   0  
    Reproductive system disorder:      
    testicular disorder
 
0
 
0
 
0
 
1 (10.0)
 
*

Except for the “No. patients” row, all data are presented as number of subjects experiencing adverse event (%).

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