Table 3.

Effect of PSC-833 on outcome at 5 years



DNR/Ara-C; N = 211

DNR/Ara-C + PSC-833; N = 208


End point
No. of events
Probability of outcome at 5 y, % (95% CI)
No. of events
Probability of outcome at 5 y, % (95% CI)
P
RR*(95% CI)
CR rate   101   48 (41-55)   112   54 (47-61)   .22   1.27 (0.87-1.87)  
Event-free survival   192   8 (5-12)   192   7 (4-11)   .53   1.07 (0.87-1.30)  
Overall survival   181   10 (6-15)   182   10 (6-15)   .52   1.07 (0.87-1.32)  
Disease-free survival after 1st CR   82   17 (11-26)   96   13 (8-20)   .06   1.33 (0.99-1.78)  
Relapse after 1st CR  72   72 ± 5   82   74 ± 4   .10   1.31 (0.95-1.79)  
Death in 1st Cr
 
10
 
10 ± 3
 
14
 
13 ± 3
 
.36
 
1.47 (0.65-3.32)
 


DNR/Ara-C; N = 211

DNR/Ara-C + PSC-833; N = 208


End point
No. of events
Probability of outcome at 5 y, % (95% CI)
No. of events
Probability of outcome at 5 y, % (95% CI)
P
RR*(95% CI)
CR rate   101   48 (41-55)   112   54 (47-61)   .22   1.27 (0.87-1.87)  
Event-free survival   192   8 (5-12)   192   7 (4-11)   .53   1.07 (0.87-1.30)  
Overall survival   181   10 (6-15)   182   10 (6-15)   .52   1.07 (0.87-1.32)  
Disease-free survival after 1st CR   82   17 (11-26)   96   13 (8-20)   .06   1.33 (0.99-1.78)  
Relapse after 1st CR  72   72 ± 5   82   74 ± 4   .10   1.31 (0.95-1.79)  
Death in 1st Cr
 
10
 
10 ± 3
 
14
 
13 ± 3
 
.36
 
1.47 (0.65-3.32)
 

RR indicates relative risk of event.

*

For CR rate, RR should be read as odds ratio (OR); OR and 95% CI are based on logistic regression. For all survival end points, RR should be read as hazard ratio (HR); HR and 95% CI are based on Cox regression analysis.

Relapse after first CR and death in first CR are competing risks; plus-minus values are the actuarial means ± standard error.

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