Withdrawal due to adverse events

Method

Proportion of randomised participants who permanently discontinued study treatment with an adverse event recorded as the reason for discontinuation, taken from the trial disposition table or CONSORT flow diagram.

The method is part of the endpoint identity. Studies measuring the same quantity by a different method are held as separate endpoints.

Notes

A tolerability endpoint, not a safety-event count. Confused with any-adverse-event incidence and with serious adverse event incidence, and the confusion is not benign: an agent can raise the number of reported events while lowering discontinuations (mild, transient, tolerated), so the two CAN MOVE IN OPPOSITE DIRECTIONS from the same trial. Also excludes all-cause withdrawal, which mixes in loss to follow-up and consent withdrawal and is a measure of trial conduct rather than a property of the intervention.

Findings

1 finding from 1 compound, strongest first.

• curcumin — no detected effect on

  BLikelyGrade B, Likely. Human evidence, limited replication or design limits.FindingNull result

  “There was no difference between patients receiving curcuminoids and those receiving placebo with regard to incidence of treatment withdrawal due to adverse events (RR: 0.90 [95% CI: 0.21, 3.79]).”

  Study

  meta-analysis

  Population

  adults with knee osteoarthritis; curcuminoid vs placebo; safety endpoint

  Effect 0.9 risk ratio, 95% CI 0.21 to 3.79

  Efficacy of curcumin and Boswellia for knee osteoarthritis: Systematic review and meta-analysis.2018PMID:29622343