Table 8.

Number and frequency of hematologic and nonhematologic AEs by time


AEs

First quarter

Second quarter

Second half year
Hema AE       
   Grade 3   100   0.17   49   0.09   31   0.03  
   Grade 4   15   0.03   4   0.007   1   < 0.001  
   Total   115   0.20   53   0.10   32   0.03  
Nonhema AE       
   Grade 1   324   0.56   121   0.23   99   0.10  
   Grade 2   98   0.15   37   0.06   30   0.03  
   Grade 3   15   0.03   6   0.01   6   0.006  
   Grade 4   1   0.001   2   0.004   1   < 0.001  
   Total
 
438
 
0.76
 
166
 
0.31
 
136
 
0.13
 

AEs

First quarter

Second quarter

Second half year
Hema AE       
   Grade 3   100   0.17   49   0.09   31   0.03  
   Grade 4   15   0.03   4   0.007   1   < 0.001  
   Total   115   0.20   53   0.10   32   0.03  
Nonhema AE       
   Grade 1   324   0.56   121   0.23   99   0.10  
   Grade 2   98   0.15   37   0.06   30   0.03  
   Grade 3   15   0.03   6   0.01   6   0.006  
   Grade 4   1   0.001   2   0.004   1   < 0.001  
   Total
 
438
 
0.76
 
166
 
0.31
 
136
 
0.13
 

The frequency provides an estimate of the number of AEs per patient per month and was calculated dividing, for each time period, the number of AEs by the number of months and by the number of patients at risk (191 in the first quarter, 178 in the second quarter, and 170 in the second half year).

Hema indicates hematologic; nonhema, nonhematologic.

Close Modal

or Create an Account

Close Modal
Close Modal