Adverse events in the placebo arm of maintenance therapy trials in advanced ovarian cancer: A systematic review and meta-analysis

Simon, Sandy; Francis, Katherine E.; Dalrymple, Janene E.; Gebski, Val; Lord, Sarah J.; Friedlander, Michael; Lee, Chee Khoon

doi:10.1016/j.ejca.2022.04.022

Cited by 2 publications

(1 citation statement)

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“…In particular, the unexpectedly high rates of pruritus in the placebo arm of RCTs involving bile acid modulating agents provide a useful comparator to gauge the impact of Farnesoid X receptor agonists on pruritus. The current study builds on existing meta-analyses of AEs in the placebo arm in other diseases (71)(72)(73).…”

Section: Discussionmentioning

confidence: 99%

Placebo Adverse Events in Non-alcoholic Steatohepatitis Clinical Trials: A Pooled Analysis of 2,944 Participants

Tay

Lin

et al. 2022

Am J Gastroenterol

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INTRODUCTION:In the absence of an effective treatment for non-alcoholic steatohepatitis (NASH), a randomized, placebo-controlled trial (RCT) remains the current gold standard study design in NASH. As NASH is a largely asymptomatic disease, the side effects of potential therapies require careful evaluation, therefore a pooled rate of the adverse events (AEs) in placebo-treated patients serves as a useful comparator for safety. Therefore, we performed a systematic review and meta-analysis to estimate the rate of AEs among participants in the placebo arm of NASH RCTs.METHODS:Medline, Embase and Cochrane Central Register of Controlled Trials were searched to include clinical trials in phase 2–4 NASH RCTs with placebo treatment arms. A pooled proportions of AEs were analyzed using a generalized linear mixed model with Clopper-Pearson intervals.RESULTS:A total of 41 RCTs (2,944 participants on placebo) were included in this meta-analysis. A total of 68% (confidence interval [CI] 55%–77%) of participants on placebo experienced an AE, 7.8% (5.7%–10%) experienced serious AEs and 3.1% (CI: 1.9%–5.1%) experienced AEs leading to discontinuation. A significantly higher proportion of participants experienced serious AEs in phase 3 studies compared to in phase 2 studies (P < 0.01) and in pharmaceutical funded studies as compared to studies which were federal-funded studies (P < 0.01). An analysis of clinical trials evaluating bile acid modulating agents determined that 10% (CI: 5.5%–18%) of participants receiving placebo developed pruritus.DISCUSSION:The present study summarizes the AEs with NASH placebo. Among participants in the placebo arm in NASH, two-third experienced an AE, and nearly 10% experienced a serious AE.

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Section: Discussionmentioning

confidence: 99%