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A survey of inclusion of the time element when reporting adverse effects in randomised controlled trials of cyclo-oxygenase-2 and tumour necrosis factor α inhibitors


Background: The adequacy of reporting the time element in adverse effects in articles on randomised clinical trials of cyclo-oxygenase-2 and tumour necrosis factor (TNF)α antagonists was surveyed.

Methods: Prominent rheumatology and general/internal medicine journals were searched for all randomised controlled trials published about cyclo-oxygenase-2 and TNFα inhibitor use in rheumatological diseases up to November 2005. Reporting of time to the occurrence of the adverse effects, the use of patient years as the time frame of the reported adverse effects and the use of annual standard incidence ratios based on the surveillance, epidemiology and end-results (SEER) programme when reporting neoplasms as potential adverse effects of TNFα antagonists were specifically tabulated.

Results: Only 23 of 70 (33%) of all articles gave the specific time of onset of an adverse effect. Nine studies used patient years to report the adverse effects and six studies used annual standard incidence ratios, using SEER, as the comparator.

Conclusion: In reporting of adverse effects in randomised clinical trials, a particularly neglected issue is the reporting of the time dimension of adverse effects.

  • COX-2, cyclo-oxygenase-2
  • RCT, randomised controlled trial
  • SAE, serious/severe adverse event
  • SEER, surveillance, epidemiology and end-results
  • TNF, tumour necrosis factor

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