Table 5.
Toxicities: Hydroxyurea Group vs. Placebo Group
| Clinical Toxicity Events | Hydroxyurea (N=96) (Subject-yrs=189)
|
Placebo (N=97) (Subject-yrs=185)
|
Hazard Ratio^ (95% CI) | p-value* | ||
|---|---|---|---|---|---|---|
| Events | Subjects | Events | Subjects | |||
| Absolute Neutrophil Count <500/mm3 | 5 | 5 | 2 | 2 | 2·5 (0·5 – 13) | 0·26 |
|
| ||||||
| Absolute Neutrophil Count 500–1250/mm3 | 107 | 45 | 34 | 18 | 3·0 (1·7 – 5·1) | <0·001 |
|
| ||||||
| Thrombocytopaenia (platelet count <80 ×103/mm3) | 12 | 11 | 8 | 7 | 1·6 (0·6 – 4·1) | 0·32 |
|
| ||||||
| Severe anaemia (Hb<7 g/dL+ARC<80×103/mm3) | 1 | 1 | 2 | 2 | 0·47 (0·04 – 5·2) | 0·53 |
|
| ||||||
| ALT (>150 U/L) | 3 | 2 | 1 | 1 | 2·0 (0·2 – 22) | 0·56 |
|
| ||||||
| Bilirubin (>10 mg/dL) | 0 | 0 | 1 | 1 | 0·31 | |
|
| ||||||
| Creatinine (≥2× baseline + ≥1·0 mg/dL) | 0 | 0 | 0 | 0 | ||
|
| ||||||
| Skin and Subcutaneous Disorders | 122 | 62 | 165 | 69 | 0·74 (0·5 – 1·0) | 0·08 |
^
Hazard ratio and confidence interval are generated from a Cox model.
*
p-values are generated from log rank life tests comparing the time to first event between the two treatment groups.
ARC = absolute reticulocyte count
ALT = alanine aminotransferase
CI = Confidence Interval