CTCAE
peripheral neuropathy, Neuropathy, neuropathy
ADVERSE EVENTS, PERIPHERAL NEUROPATHY, NEUROPATHY, NEUROPATHY
According to the CTCAE, 57.8 and 55.6% of the push and one‐hour group developed VIPN, of which 15.6 and 13.3% developed severe VIPN, respectively (Grade 3 or higher) (Table Incidence of vincristine‐induced peripheral neuropathy of participants in the randomization groups (push‐ and one‐hour administration of vincristine).Total group consisted of 70 participants (push group: 33, one‐hour group: 37)Total group consisted of 59 participants (push group: 28, one‐hour group: 31)Total group consisted of 11 participants (push group: 5, one‐hour group: 6).Abbreviations: CTCAE, common terminology of adverse events; IQR, interquartile range; ped‐mTNS, pediatric‐modified Total Neuropathy Score; VIPN, vincristine‐induced peripheral neuropathy.The effect of one‐hour administration in comparison with push administration of vincristine on the development of vincristine‐induced peripheral neuropathy over time.
Total group consisted of 60 participants (without concurrent azole antifungals: 49, with concurrent azole antifungals: 11).Abbreviations: CI, confidence interval; CTCAE, common terminology criteria for adverse events; OR, odds ratio; ped‐mTNS, pediatric modified total neuropathy score; VIPN, vincristine‐induced peripheral neuropathy.Estimated total CTCAE score over time in the randomization groups including 95% confidence interval (corrected for baseline). Median days and IQR per measurement moment are as follows: measurement 1: push = 29 (27; 42) and one‐hour = 28 (25; 47), measurement 2: push = 163 (129; 218) and one‐hour = 167 (99.5; 208), measurement 3: push = 403 (276; 518) and one‐hour = 387 (228; 466), measurement 4: push = 638 (529; 715) and one‐hour = 644 (410.5; 666), measurement 5: push = 915 (679.3; 957) and one‐hour = 884 (500; 953), and measurement 6: push = 868 (625.3; 895) and one‐hour = 469 (426.5–827). For the number of participants per measurement moment: see Figure Age, sex, diagnosis, and racial background were not identified as modifiers in the relationship between VIPN according to CTCAE and randomization group. However, concurrent azoles was identified as a modifier in this relationship (Estimated total CTCAE score over time in the randomization groups per concurrent azoles, including 95% confidence interval. Number of participants analyzed per group are as follows: push administration: No significant difference was found between the randomization groups all VIPN measurements during vincristine treatment and ≥6 months after last vincristine administration were compared (Figure The results were similar in the per protocol analyses (data not shown).