Table I.
Peripheral sensory neurotoxicity evaluation at each visit at weeks 4, 8 and 12.
| Full analysis set | Per-protocol set | |||||||
|---|---|---|---|---|---|---|---|---|
| Time | ALC (%) | Placebo (%) | χ2 | Pa | ALC (%) | Placebo (%) | χ2 | Pa |
| Week 4 | ||||||||
| Valid | 29 (26.6) | 16 (13.8) | 5.766 | 0.016 | 26 (27.4) | 14 (13.0) | 6.629 | 0.010 |
| Invalid | 80 (73.4) | 100 (86.2) | 69 (72.6) | 94 (87.0) | ||||
| Week 8 | ||||||||
| Valid | 55 (50.5) | 28 (24.1) | 16.722 | <0.001 | 49 (51.6) | 25 (23.1) | 17.636 | <0.001 |
| Invalid | 54 (49.1) | 88 (75.9) | 46 (48.4) | 83 (76.9) | ||||
| Week 12 | ||||||||
| Valid | 63 (57.8) | 46 (39.7) | 7.406 | 0.007 | 57 (60.0) | 41 (38.0) | 9.830 | 0.002 |
| Invalid | 46 (42.2) | 70 (60.3) | 38 (40.0) | 67 (62.0) | ||||
Neurotoxicities were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0). Neurotoxicities were evaluated in patients before enrollment, and at weeks 4, 8 and 12. Neurotoxicity was defined as valid if the grade at weeks 4, 8 and 12 decreased compared with prior to enrollment. Otherwise, it was defined as invalid. ALC, acetyl-L-carnitine group
a
P-values were calculated with a two-sided χ2 test.