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Table 2 Primary, secondary and tertiary outcomes of the study

From: Randomized double-blind, placebo-controlled study of topical diclofenac in the prevention of hand-foot syndrome in patients receiving capecitabine (the D-TORCH study)

Outcome

Description

Primary outcomes

Grade 2 or higher HFS (proportion)

Secondary

All grades of HFS (proportion)

Time to develop HFS (days)

Patient-reported outcomes using HFS 14 questionnaire

Adherence with topical application

HFS related dose changes and delays in capecitabine

Adverse events (NCI CTCAE version 5.0)

Tertiary

COX-2 levels

  1. HFS hand-foot syndrome, NCI National Cancer Institute, CTCAE Common Terminology Criteria for Adverse Events, COX-2 cycloxygenase-2