TABLE 1.
Distribution of demographic variables by randomization arms
| Clinical Feature (n) | Gabapentin Arm, n (%) | Placebo Arm, n (%) | P |
|---|---|---|---|
| Protocol Completion? | 1.0 | ||
| Yes (45) | 22 (49) | 23 (51) | |
| No (6) | 3 (50) | 3 (50) | |
| Sex | |||
| Male (30) | 14 (47) | 16 (53) | 0.779 |
| Female (21) | 11 (52) | 10 (48) | |
| Primary ALL Diagnosis | |||
| Early Pre B (2) | 1 (50) | 1 (50) | 0.765 |
| Early T Cell (1) | 0 (0) | 1 (100) | |
| Pre-B (42) | 20 (48) | 22 (52) | |
| Pre-T Cell (6) | 4 (67) | 2 (33) | |
| Race | |||
| Asian and White (1) | 0 (0) | 1 (100) | 0.771 |
| Black (3) | 1 (33) | 2 (67) | |
| Black and White (3) | 1 (33) | 2 (67) | |
| White (44) | 23 (52) | 21 (48) | |
| Vincristine dose group | |||
| Week 1-Induction (31) | 13 (42) | 18 (58) | 0.318 |
| Week 2-Induction (13) | 9 (69) | 4 (30) | |
| Week 7-Reinduction I (6) | 3 (50) | 3 (50) | |
| Week 17-Reinduction II (1) | 0 (0) | 1 (100) | |
| Total risk group | |||
| Low (21) | 14 (67) | 7 (33) | 0.048* |
| Standard/High (30) | 11 (37) | 19 (63) | |
| Age range | |||
| 1–3 y (16) | 8 (50) | 8 (50) | 1.0 |
| 4–7 y (15) | 7 (47) | 8 (53) | |
| >7 y (20) | 10 (50) | 10 (50) | |
| Baseline Pain Score in the previous 24 hours | |||
| <5 (33) | 17 (52) | 16 (48) | |
| ≥5 (18) | 8 (44) | 10 (56) | |
| Baseline Pain Score now | |||
| <5 (40) | 20 (50) | 20 (50) | 1.0 |
| ≥5 (11) | 5 (45) | 6 (54) | |
Abbreviations: ALL, acute lymphoblastic leukemia
*
Two-sided P<0.05 by Chi-squared test