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

Overview of attention for article published in BMC Medicine, August 2015
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About this Attention Score

  • In the top 5% of all research outputs scored by Altmetric
  • High Attention Score compared to outputs of the same age (98th percentile)

Mentioned by

news
1 news outlet
blogs
4 blogs
twitter
118 tweeters
facebook
1 Facebook page
googleplus
2 Google+ users

Citations

dimensions_citation
48 Dimensions

Readers on

mendeley
53 Mendeley
citeulike
2 CiteULike
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Title
Comparison of serious adverse events posted at ClinicalTrials.gov and published in corresponding journal articles
Published in
BMC Medicine, August 2015
DOI 10.1186/s12916-015-0430-4
Pubmed ID
Authors

Eve Tang, Philippe Ravaud, Carolina Riveros, Elodie Perrodeau, Agnes Dechartres

Abstract

The reporting of serious adverse events (SAEs) in clinical trials is crucial to assess the balance between benefits and risks. For trials with serious adverse events posted at ClinicalTrials.gov, we assessed the consistency between SAEs posted at ClinicalTrials.gov and those published in corresponding journal articles. All records from ClinicalTrials.gov up to February 2014 were automatically exported in XML format. Among these, we identified all phase III or IV randomized controlled trials with at least one SAE posted. For a random sample of 300 of these trials, we searched for corresponding publications using MEDLINE via PubMed and extracted safety results from the articles. Among the sample of 300 trials with SAEs posted at ClinicalTrials.gov, 78 (26 %) did not have a corresponding publication, and 20 (7 %) had a publication that did not match the ClinicalTrials.gov 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 ClinicalTrials.gov. For 31 trials, the number of SAEs was greater at ClinicalTrials.gov 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. Many trials with SAEs posted at ClinicalTrials.gov are not yet published, omit the reporting of these SAEs in corresponding publications, or report a discrepant number of SAEs as compared with ClinicalTrials.gov. These results underline the need to consult ClinicalTrials.gov for more information on serious harms.

Twitter Demographics

The data shown below were collected from the profiles of 118 tweeters who shared this research output. Click here to find out more about how the information was compiled.

Mendeley readers

The data shown below were compiled from readership statistics for 53 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Russia 1 2%
Unknown 52 98%

Demographic breakdown

Readers by professional status Count As %
Student > Master 9 17%
Student > Ph. D. Student 7 13%
Other 5 9%
Student > Bachelor 5 9%
Student > Doctoral Student 4 8%
Other 16 30%
Unknown 7 13%
Readers by discipline Count As %
Medicine and Dentistry 30 57%
Pharmacology, Toxicology and Pharmaceutical Science 4 8%
Social Sciences 2 4%
Psychology 2 4%
Agricultural and Biological Sciences 1 2%
Other 4 8%
Unknown 10 19%

Attention Score in Context

This research output has an Altmetric Attention Score of 103. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 28 September 2019.
All research outputs
#215,250
of 16,167,952 outputs
Outputs from BMC Medicine
#183
of 2,531 outputs
Outputs of similar age
#3,602
of 237,373 outputs
Outputs of similar age from BMC Medicine
#1
of 1 outputs
Altmetric has tracked 16,167,952 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 98th percentile: it's in the top 5% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 2,531 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 37.5. This one has done particularly well, scoring higher than 92% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 237,373 tracked outputs that were published within six weeks on either side of this one in any source. This one has done particularly well, scoring higher than 98% of its contemporaries.
We're also able to compare this research output to 1 others from the same source and published within six weeks on either side of this one. This one has scored higher than all of them