Table 2.

Outcome of 109 patients randomized in the 2 trials

Trial 1Trial 2
No ATGATG 7.5 (mg/kg)PNo ATGATG 15 (mg/kg)P
No. of patients 25 29  28 27  
Engraftment       
 Patients with PMN counts ≥ 0.5 × 109/L (%) 84 83  89 89  
 Days to reach PMN count = 0.5 × 109/L 17 (13-28)* 18 (13-35) 19 (14-32) 19 (13-36) .6  
 Patients with Plt counts ≥ 50 × 109/L (%) 76 76  61 60  
 Days to reach Plt count = 50 × 109/L 21 (15-203) 24 (16-91) 23 (16-79) 38 (17-92) .02 
CMV antigenemia (%) 88 83 67 78 .2  
Acute GVHD (no. of patients)       
 0-I  17  
 II   
 III-IV 9 (36%) 12 (41%) 14 (50%) 3 (11%) .001* 
Chronic GVHD (%) 65 38 .08 59 41 .3  
Patients surviving (%) 52 55  46 41  
Causes of death       
 GVHD (%) 32 28  39 11  
 Infections (%)  30  
 MOF (%)   
 Leukemia (%) 18 .07  
Follow-up (median days)       
 Surviving patients 1040 855  540 530  
 Deceased patients 150 70  66 68  
Trial 1Trial 2
No ATGATG 7.5 (mg/kg)PNo ATGATG 15 (mg/kg)P
No. of patients 25 29  28 27  
Engraftment       
 Patients with PMN counts ≥ 0.5 × 109/L (%) 84 83  89 89  
 Days to reach PMN count = 0.5 × 109/L 17 (13-28)* 18 (13-35) 19 (14-32) 19 (13-36) .6  
 Patients with Plt counts ≥ 50 × 109/L (%) 76 76  61 60  
 Days to reach Plt count = 50 × 109/L 21 (15-203) 24 (16-91) 23 (16-79) 38 (17-92) .02 
CMV antigenemia (%) 88 83 67 78 .2  
Acute GVHD (no. of patients)       
 0-I  17  
 II   
 III-IV 9 (36%) 12 (41%) 14 (50%) 3 (11%) .001* 
Chronic GVHD (%) 65 38 .08 59 41 .3  
Patients surviving (%) 52 55  46 41  
Causes of death       
 GVHD (%) 32 28  39 11  
 Infections (%)  30  
 MOF (%)   
 Leukemia (%) 18 .07  
Follow-up (median days)       
 Surviving patients 1040 855  540 530  
 Deceased patients 150 70  66 68  

MOF, multiorgan failure; PMN, neutrophils; Plt, platelets.

*

Median and range, χ2 test.

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