Table 3.

Summary of number of deaths



Weeks on/off treatment, by dosage
4/2
4/1

50 mg
75 mg
50 mg
Total
No. deaths on study occurring no more than 30 days from stoppage of treatment   6   2   3   11  
No. deaths on follow-up   1   0   1   2  
Cause of death, no.     
    Infection   2   1   2   5  
    Leukocytosis   3*  0   1   4  
    Bleeding   1   0   1   4  
    Myocardial infarction   1   0   0   1  
    Cardiac insufficiency
 
0
 
1
 
0
 
1
 


Weeks on/off treatment, by dosage
4/2
4/1

50 mg
75 mg
50 mg
Total
No. deaths on study occurring no more than 30 days from stoppage of treatment   6   2   3   11  
No. deaths on follow-up   1   0   1   2  
Cause of death, no.     
    Infection   2   1   2   5  
    Leukocytosis   3*  0   1   4  
    Bleeding   1   0   1   4  
    Myocardial infarction   1   0   0   1  
    Cardiac insufficiency
 
0
 
1
 
0
 
1
 
*

Two of the deaths occurred in follow-up.

Considered possibly related to the drug, on cycle 2.

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