Table 1

Hydroxyurea effects on pain, dactylitis, ACS, and hospitalization

Hydroxyurea, N = 96, n (%)Placebo, N = 97, n (%)P
Pain   < .001* 
    Total events 177 375  
    Subjects with 0 events 34 (35) 22 (23)  
    Subjects with 1 event 29 (30) 15 (15)  
    Subjects with 2 or 3 events 20 (21) 19 (20)  
    Subjects with 4+ events 13 (14) 41 (42)  
Dactylitis   < .001 
    Total events 24 123  
    Subjects with 0 events 82 (86) 55 (57)  
    Subjects with 1 event 6 (6) 14 (14)  
    Subjects with 2 events 6 (6) 8 (8)  
    Subjects with 3 events 2 (2) 6 (6)  
    Subjects with 4+ events 0 (0) 14 (14)  
ACS events   .03 
    Total events 27  
    Subjects with 0 events 89 (93) 79 (82)  
    Subjects with 1 event 6 (6) 10 (10)  
    Subjects with 2 or 3 events 1 (1) 8 (8)  
Hospitalizations   .008* 
    Total events 232 324  
    Subjects with 0 events 27 (28) 13 (13)  
    Subjects with 1 event 22 (23) 16 (17)  
    Subjects with 2 or 3 events 26 (27) 28 (29)  
    Subjects with 4+ events 21 (22) 40 (41)  
Hydroxyurea, N = 96, n (%)Placebo, N = 97, n (%)P
Pain   < .001* 
    Total events 177 375  
    Subjects with 0 events 34 (35) 22 (23)  
    Subjects with 1 event 29 (30) 15 (15)  
    Subjects with 2 or 3 events 20 (21) 19 (20)  
    Subjects with 4+ events 13 (14) 41 (42)  
Dactylitis   < .001 
    Total events 24 123  
    Subjects with 0 events 82 (86) 55 (57)  
    Subjects with 1 event 6 (6) 14 (14)  
    Subjects with 2 events 6 (6) 8 (8)  
    Subjects with 3 events 2 (2) 6 (6)  
    Subjects with 4+ events 0 (0) 14 (14)  
ACS events   .03 
    Total events 27  
    Subjects with 0 events 89 (93) 79 (82)  
    Subjects with 1 event 6 (6) 10 (10)  
    Subjects with 2 or 3 events 1 (1) 8 (8)  
Hospitalizations   .008* 
    Total events 232 324  
    Subjects with 0 events 27 (28) 13 (13)  
    Subjects with 1 event 22 (23) 16 (17)  
    Subjects with 2 or 3 events 26 (27) 28 (29)  
    Subjects with 4+ events 21 (22) 40 (41)  

ACS indicates acute chest syndrome.

*

P value was derived from the χ2 test comparing difference in frequency of events between hydroxyurea and placebo groups.

P value was derived from the Fisher exact test comparing difference in frequency of events between hydroxyurea and placebo groups. There were a total of 374 patients-years of on study observation; the median follow-up was 2 years/patient.

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