Table 4.
Adverse Events: Hydroxyurea Group vs. Placebo Group
| Hydroxyurea (N=96) (Subject-years=189) |
Placebo (N=97) (Subject-years=185) |
Hazard Ratio^ (95% CI) | p-value* | |||
|---|---|---|---|---|---|---|
| Events | Subjects | Events | Subjects | |||
| Pain (all reports including pain) | 177 | 62 | 375 | 75 | 0·59 (0·42 – 0·83) | 0·002 |
|
| ||||||
| Pain alone | 63 | 37 | 121 | 55 | 0·54 (0·36 – 0·83) | 0·004 |
|
| ||||||
| Acute Chest Syndrome | 8 | 7 | 27 | 18 | 0·36 (0·15 – 0·87) | 0·02 |
|
| ||||||
| Hospitalisation (for any cause) | 232 | 69 | 324 | 84 | 0·73 (0·53 – 1·00) | 0·05 |
|
| ||||||
| Transfusion | 35 | 20 | 63 | 33 | 0·55 (0·32 – 0·96) | 0·03 |
|
| ||||||
| Dactylitis | 24 | 14 | 123 | 42 | 0·27 (0·15 – 0·50) | <0·001 |
|
| ||||||
| Stroke | 0 | 0 | 1 | 1 | 0·31 | |
|
| ||||||
| Priapism | 4 | 3 | 2 | 2 | 1·48 (0·25 – 8·84) | 0·67 |
|
| ||||||
| Sepsis or Bacteraemia | 3 | 2 | 6 | 5 | 0·40 (0·08 – 2·06) | 0·26 |
|
| ||||||
| Splenomegaly | 127 | 32 | 88 | 36 | 0·87 (0·54 – 1·40) | 0·56 |
|
| ||||||
| Splenic Sequestration | 12 | 8 | 12 | 9 | 0·88 (0·34 – 2·27) | 0·79 |
|
| ||||||
| Gastroenteritis | 26 | 18 | 70 | 41 | 0·35 (0·20 – 0·60) | <0·001 |
|
| ||||||
| Death | 0 | 0 | 0 | 0 | ||
^
Hazard ratio and confidence interval are generated from a Cox model.
*
p-values are generated from the log rank life test comparing the time to first event between the two treatment groups.
CI = Confidence Interval