Selected laboratory characteristics of the NOHARM randomized population
| Laboratory measures . | Month 12 . | Change from baseline . | ||||
|---|---|---|---|---|---|---|
| Hydroxyurea . | Placebo . | P . | Hydroxyurea . | Placebo . | P . | |
| Hemoglobin, g/dL | 8.7 (1.3) | 7.4 (1.0) | <.001 | 1.2 (1.2) | −0.1 (0.9) | <.001 |
| MCV, fL | 88 (9) | 81 (8) | <.001 | 9 (7) | 1 (5) | <.001 |
| Fetal hemoglobin [HbF/(HbF + HbS)], % | 22.9 (8.6) | 10.4 (4.8) | <.001 | 8.5 (6.7) | −3.1 (3.3) | <.001 |
| Enrollment age below median | 24.1 (8.5) | 12.1 (4.8) | <.001 | 7.9 (7.4) | −4.1 (3.5) | <.001 |
| Enrollment age above median | 21.4 (8.7) | 8.8 (4.2) | <.001 | 9.3 (5.6) | −2.2 (2.8) | <.001 |
| ARC, ×109/L | 247 (107) | 391 (122) | <.001 | −144 (119) | 11 (119) | <.001 |
| WBC count, ×109/L | 13.7 (5.1) | 18.0 (5.1) | <.001 | −5.4 (5.8) | −0.7 (5.1) | <.001 |
| ANC, ×109/L | 5.2 (2.5) | 6.6 (2.6) | <.001 | −1.3 (3.0) | 0.4 (3.0) | <.001 |
| Platelets, ×109/L | 371 (166) | 446 (143) | <.001 | 12 (184) | 28 (152) | .50 |
| ALT, U/L | 19 (8) | 18 (8) | .59 | 0.8 (11) | −0.9 (10) | .28 |
| Creatinine, mg/dL | 0.32 (0.11) | 0.31 (0.08) | .64 | 0.04 (0.13) | 0.04 (0.10) | .92 |
| Laboratory measures . | Month 12 . | Change from baseline . | ||||
|---|---|---|---|---|---|---|
| Hydroxyurea . | Placebo . | P . | Hydroxyurea . | Placebo . | P . | |
| Hemoglobin, g/dL | 8.7 (1.3) | 7.4 (1.0) | <.001 | 1.2 (1.2) | −0.1 (0.9) | <.001 |
| MCV, fL | 88 (9) | 81 (8) | <.001 | 9 (7) | 1 (5) | <.001 |
| Fetal hemoglobin [HbF/(HbF + HbS)], % | 22.9 (8.6) | 10.4 (4.8) | <.001 | 8.5 (6.7) | −3.1 (3.3) | <.001 |
| Enrollment age below median | 24.1 (8.5) | 12.1 (4.8) | <.001 | 7.9 (7.4) | −4.1 (3.5) | <.001 |
| Enrollment age above median | 21.4 (8.7) | 8.8 (4.2) | <.001 | 9.3 (5.6) | −2.2 (2.8) | <.001 |
| ARC, ×109/L | 247 (107) | 391 (122) | <.001 | −144 (119) | 11 (119) | <.001 |
| WBC count, ×109/L | 13.7 (5.1) | 18.0 (5.1) | <.001 | −5.4 (5.8) | −0.7 (5.1) | <.001 |
| ANC, ×109/L | 5.2 (2.5) | 6.6 (2.6) | <.001 | −1.3 (3.0) | 0.4 (3.0) | <.001 |
| Platelets, ×109/L | 371 (166) | 446 (143) | <.001 | 12 (184) | 28 (152) | .50 |
| ALT, U/L | 19 (8) | 18 (8) | .59 | 0.8 (11) | −0.9 (10) | .28 |
| Creatinine, mg/dL | 0.32 (0.11) | 0.31 (0.08) | .64 | 0.04 (0.13) | 0.04 (0.10) | .92 |
Results are shown only for participants who had data for the measure both at baseline and at 12 mo, as mean (SD) or the percentage of participants affected. The median age at enrollment was 2.2 y. Treatment group differences at month 12 and changes from baseline were tested by Welch’s t tests.