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Balancing the outcomes: reporting adverse events

Anthony C Keech, Susan M Wonders, Val J Gebski and David I Cook
Med J Aust 2004; 181 (4): 215-218.
Published online: 16 August 2004

When decisions about a new intervention are being made, the “net clinical benefit” of the intervention needs to be assessed. This requires balancing all the reported benefits and side effects of the intervention. The adverse events experienced in a trial must be known in sufficient detail for their severity and relationship to treatment allocation to be judged. Reporting of such events is the subject of item 19 of the CONSORT statement (Box 1).1

  • Anthony C Keech1
  • Susan M Wonders2
  • Val J Gebski3
  • David I Cook4

  • 1 NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW.
  • 2 Department of Physiology, University of Sydney, Sydney, NSW.

Correspondence: 

Acknowledgements: 

We thank Rhana Pike for expert assistance in preparation of the manuscript.

Competing interests:

None identified.

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