Table 3.

Outcome of Induction Chemotherapy

Group A Group BAll PEG-rHuMGDF Patients Placebo
PEG-rHuMGDF 2.5 μg/kg/d to Target PEG-rHuMGDF 5 μg/kg/d to Target PEG-rHuMGDF 2.5 μg/kg/d Day 8PEG-rHuMGDF 2.5 μg/kg/d Days 8 to 14
Induction 1 
 No. of patients  24  24  12  14  74  34 
  Complete remission  16  13  8  7  44  21 
  Persistant disease  8  10  3  6  27  
  Induction 1 deaths  0  1  1  0  2  
  Remission rate after induction 1  67%  54%  67% 50%  59%  62%  
Induction 2  
 No. of patients 7  9  2  4  22  9  
  Complete remission  4  1  2  10  7  
  Persistant disease  4  0  2  10  2  
  Not assessed  0  1  1  2  0  
  Remission rate after induction 2  43%  44% 50%  50%  45%  78%  
 
Overall remission rate 79%  71%  75%  64%  73%  82% 
Group A Group BAll PEG-rHuMGDF Patients Placebo
PEG-rHuMGDF 2.5 μg/kg/d to Target PEG-rHuMGDF 5 μg/kg/d to Target PEG-rHuMGDF 2.5 μg/kg/d Day 8PEG-rHuMGDF 2.5 μg/kg/d Days 8 to 14
Induction 1 
 No. of patients  24  24  12  14  74  34 
  Complete remission  16  13  8  7  44  21 
  Persistant disease  8  10  3  6  27  
  Induction 1 deaths  0  1  1  0  2  
  Remission rate after induction 1  67%  54%  67% 50%  59%  62%  
Induction 2  
 No. of patients 7  9  2  4  22  9  
  Complete remission  4  1  2  10  7  
  Persistant disease  4  0  2  10  2  
  Not assessed  0  1  1  2  0  
  Remission rate after induction 2  43%  44% 50%  50%  45%  78%  
 
Overall remission rate 79%  71%  75%  64%  73%  82% 

Remission rate odds ratio (all PEG-rHuMGDF patients vplacebo patients). Induction 1: 0.91 (0.40, 2.09); Induction 2: 0.23 (0.04, 1.35).

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