Table 1.

Follow-up of patients with SCN and SDS in the SCNIR




No.

Person-y

Median no. (range) of pre-Rx CBC

Median G-CSF dose at 6 mo, μg/kg/d

Total MDS/AML, no.

Total deaths from sepsis, no.

MDS/AML crude rate, % per y*

Death from sepsis crude rate, % per y
SCN         
    Group 1   374   2043   NA   NA   44   19   2.2   0.9  
    Group 2   365   2007   NA   6.0   44   19   2.2   0.9  
    Group 3   305   1769   3 (1-76)   6.2   42   17   2.4   1.0  
    Group 4   307   1963   NA   6.2   41   15   2.1   0.8  
    Group 5   238   1583   9 (1-80)   8.0   34   12   2.1   0.8  
    Group 6  211   1445   12 (2-116)   8.0   33   10   2.3   0.7  
SDS         
    Group 1   29   161   NA   NA   2   2   1.2   1.2  
    Group 2   18   67   NA   4.3   2   2   3.0   3.0  
    Group 3   16   57   3 (1-19)   4.3   1   2   1.8   3.5  
    Group 4   14   65   NA   4.3   1   1   1.5   1.5  
    Group 5   9   38   3 (2-11)   4.2   1   1   2.7   2.7  
    Group 6
 
8
 
28
 
8 (4-25)
 
4.3
 
1
 
1
 
3.6
 
3.6
 



No.

Person-y

Median no. (range) of pre-Rx CBC

Median G-CSF dose at 6 mo, μg/kg/d

Total MDS/AML, no.

Total deaths from sepsis, no.

MDS/AML crude rate, % per y*

Death from sepsis crude rate, % per y
SCN         
    Group 1   374   2043   NA   NA   44   19   2.2   0.9  
    Group 2   365   2007   NA   6.0   44   19   2.2   0.9  
    Group 3   305   1769   3 (1-76)   6.2   42   17   2.4   1.0  
    Group 4   307   1963   NA   6.2   41   15   2.1   0.8  
    Group 5   238   1583   9 (1-80)   8.0   34   12   2.1   0.8  
    Group 6  211   1445   12 (2-116)   8.0   33   10   2.3   0.7  
SDS         
    Group 1   29   161   NA   NA   2   2   1.2   1.2  
    Group 2   18   67   NA   4.3   2   2   3.0   3.0  
    Group 3   16   57   3 (1-19)   4.3   1   2   1.8   3.5  
    Group 4   14   65   NA   4.3   1   1   1.5   1.5  
    Group 5   9   38   3 (2-11)   4.2   1   1   2.7   2.7  
    Group 6
 
8
 
28
 
8 (4-25)
 
4.3
 
1
 
1
 
3.6
 
3.6
 

Dose data indicates G-CSF dose in μg/kg/d at 6 months; Rx, treatment; and NA, not applicable. The pre-Rx CBCs were obtained from 3 years before treatment through the day that treatment was started. Groups were defined as follows: group 1, enrolled; group 2, enrolled with dose data; group 3, enrolled with dose data and CBC data pre-Rx; group 4, enrolled with dose data and followed beyond 18 months; group 5, enrolled with dose data and followed beyond 18 months with CBC data at 6-18 months; and group 6, enrolled with dose data and followed beyond 18 months with CBC data at 6-18 months and pre-Rx.

*

Crude rates are defined as the total number of events, divided by the person-years of follow-up, times 100%.

Includes both follow-up intervals.

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