Table 6.

Reason for removal from study


No. of patients

Reason, patient no.
4   Progressed (never responded): 8, 22, 29, 37* 
6   Progressed (after minor response): 22, 29, 29, 36, 72, 74, 213  
5   Progressed (after major response): 72, 90, 162, 300, 330  
2   Toxicity (never responded): 15, 15  
3
 
Removed for BMT after response: 62 (minor), 74 (major), 99 (major) before transplantation
 

No. of patients

Reason, patient no.
4   Progressed (never responded): 8, 22, 29, 37* 
6   Progressed (after minor response): 22, 29, 29, 36, 72, 74, 213  
5   Progressed (after major response): 72, 90, 162, 300, 330  
2   Toxicity (never responded): 15, 15  
3
 
Removed for BMT after response: 62 (minor), 74 (major), 99 (major) before transplantation
 

Minor response indicates a 50% reduction in peripheral blasts; major response, a significant clinical benefit defined as a 2-log reduction in peripheral blasts for at least 4 weeks.

*

Numbers refer to the day a given patient stopped drug.

This patient did not receive PKC412 between day 165 and day 270.

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