Fig 1.
Flow diagram of retrieved and excluded randomized controlled trials.
Legend: FDA = US Food and Drug Administration; RCT = randomized controlled trials; WdAE = withdrawal due to adverse events; ACR20 = American College of Rheumatology response criteria 20.
Fig 2.
Forest plots representing the odds ratios for the ACR20 measure of the FDA review report and the journal publication.
Legend: 95%CI = 95% confidence interval; Solid circles = FDA report; open circles = journal publication; ACR20 = American College of Rheumatology response criteria 20. Circles without confidence interval indicate outcome was not reported.
Fig 3.
Forest plots representing the odds ratios for withdrawal due to adverse events of the FDA report and peer reviewed publication.
Legend: 95%CI = 95% confidence interval; Solid circles = FDA report; open circles = journal publication. Circles without confidence interval indicate outcome was not reported.
Fig 4.
Forest plots representing the ratio of odds ratios for the ACR20 measure between FDA review analysis data and peer reviewed publication data.
Legend: ACR20 = American College of Rheumatology response criteria 20; 95%CI = 95% confidence interval. Diamonds without confidence interval indicate outcome was not reported in one or both sources.
Table 1.
Summary of discrepancies between FDA and peer-reviewed journal reports.
Fig 5.
Forest plots representing the ratio of odds ratios for the WdAE measure on pairwise comparisons between FDA review analysis data and peer reviewed publication data.
Legend: WdAE = withdrawal due to adverse events; 95%CI = 95% confidence interval. Diamonds without confidence interval indicate outcome was not reported in one or both sources.