Table 3.
Etiology of febrile events
| Hydroxyurea, N = 96 | Placebo, N = 97 | Hazard ratio† | P† | |||||
|---|---|---|---|---|---|---|---|---|
| Events | Incidence rate* | Subjects, n (%) | Events | Incidence rate* | Subjects, n (%) | |||
| Fever | 352 | 186.2 | 86 (90) | 402 | 217.4 | 88 (91) | 0.89 | .5 |
| Aplastic crisis, parvovirus | 4 | 2.1 | 4 (4) | 4 | 2.2 | 4 (4) | 0.96 | 1 |
| Acute osteomyelitis | 0 | 0 | 0 | 2 | 1.1 | 2 (2) | — | .2 |
| Bacteremia/sepsis/meningitis | 3 | 1.6 | 2 (2) | 6 | 3.2 | 5 (5) | 0.40 | .3 |
| Viral syndrome | 41 | 21.7 | 30 (31) | 48 | 26.0 | 31 (32) | 0.92 | .7 |
| Gastroenteritis | 70 | 37.1 | 44 (46) | 69 | 37.3 | 45 (46) | 0.91 | .7 |
| Otitis media | 76 | 40.3 | 36 (38) | 99 | 53.5 | 45 (46) | 0.73 | .2 |
*
Per 100 patient-years.
†
The hazard ratio (hydroxyurea vs placebo) was generated from a Cox model and the P value from the log-rank life test to compare the time to first event between the two treatment groups.