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Table 2 Outcomes of the study

From: Randomized double-blind, placebo-controlled study of oral gabapentin for prevention of neuropathy in patients receiving paclitaxel

Outcome

Description

Primary outcome

Grade 2 or higher peripheral neuropathy (proportion)

Secondary

All grades of peripheral neuropathy (proportion)

Change in ulnar/median/sural nerve conduction velocity (compared to baseline) and 3 months after therapy cessation (percentage change)

Time to develop peripheral neuropathy (days)

Patient-reported outcomes using the EORTC QLQ-CIPN20 questionnaire

Adherence with oral gabapentin

Peripheral neuropathy-related dose changes in paclitaxel

Adverse events (NCI CTCAE version 5.0)

Autonomic nervous system function (orthostatic fall in systolic blood pressure and heart rate variability with deep breathing)

  1. NCI National Cancer Institute, CTCAE Common Terminology Criteria for Adverse Events