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Comparison of serious adverse events posted at and published in corresponding journal articles

A study published in BMC Medicine this week assessed the consistency between the reporting of serious adverse events (SAEs) posted at and those published in corresponding journal articles.

Key findings (also see the Figure below) were as follows:

  • Among a sample of 300 trials with SAEs posted at, 78 (26%) did not have a corresponding publication, and 20 (7%) had a publication that did not match the record.
  • For the 202 remaining trials, 26 published articles (13%) did not mention SAEs, 4 (2%) reported no SAEs, and 33 (16%) did not report the total number of SAEs per treatment group.
  • Among the remaining 139 trials, for 44 (32%), the number of SAEs per group published did not match those posted at
  • For 31 trials, the number of SAEs was greater at than in the published article, with a difference ≥30% for at least one group for 21.
  • Only 33 trials (11%) had a publication reporting matching numbers of SAE and describing the type of SAE.

The authors concluded: “Many trials with SAEs posted at are not yet published, omit the reporting of these SAEs in corresponding publications, or report a discrepant number of SAEs as compared with These results underline the need to consult for more information on serious harms.”.

Figure: Reporting of serious adverse events (SAEs) in published articles for a random sample of 300 trials with SAEs posted at Tang et al. BMC Medicine 2015 13:189   doi:10.1186/s12916-015-0430-4


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