Table 4

Molecular response

At 3 mo
At 6 mo
At 12 mo
800-mg arm400-mg arm800-mg arm400-mg arm800-mg arm400-mg arm
No. of patients       
    Randomly assigned 108 108 108 108 108 108 
    Off treatment for AE, SAE, dropouts 7 4 12 10 18 10 
    RT-Q-PCR not done 21 15 15 13 3 11 
    Evaluable for MolR 80 89 81 85 87 87 
MMolR       
    No. of patients 13 8 34 27 43 36 
    Randomly assigned, % 12 7 31 25 40 33 
    Evaluable, % 16 9 42 32 49 41 
BCR-ABL transcripts level (BCR-ABL to ABL %)       
    Median of evaluable 1.122 2.085 0.168 0.378 0.036 0.084 
    Median of CCgRs 0.186 0.258 0.040 0.102 0.030 0.060 
At 3 mo
At 6 mo
At 12 mo
800-mg arm400-mg arm800-mg arm400-mg arm800-mg arm400-mg arm
No. of patients       
    Randomly assigned 108 108 108 108 108 108 
    Off treatment for AE, SAE, dropouts 7 4 12 10 18 10 
    RT-Q-PCR not done 21 15 15 13 3 11 
    Evaluable for MolR 80 89 81 85 87 87 
MMolR       
    No. of patients 13 8 34 27 43 36 
    Randomly assigned, % 12 7 31 25 40 33 
    Evaluable, % 16 9 42 32 49 41 
BCR-ABL transcripts level (BCR-ABL to ABL %)       
    Median of evaluable 1.122 2.085 0.168 0.378 0.036 0.084 
    Median of CCgRs 0.186 0.258 0.040 0.102 0.030 0.060 

The percentage of major molecular responses (MMolRs) was calculated both according to the intention-to-treat principle (percentage of randomly assigned patients) and on the patients who were evaluable for molecular response, including failures (percentage of evaluables). No difference was significant.

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