Barely Significant
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Post-marketing safety profile of lumacaftor/ivacaftor in cystic fibrosis treatment: a pharmacovigilance analysis based on FAERS.

Front Med (Lausanne) · 2026 · PMC12968232 · PMID 41810245

2
hedged sentences
0.0590
closest p · 1.2× alpha
0.0590
boldest claim

The sentences

did not reach statistical significancep = 0.059so close (0.05 < p ≤ 0.1)
Reports submitted by consumers were more likely to report depressive events compared to those submitted by healthcare professionals, though the result did not reach statistical significance (OR = 2.062, 95% CI: 0.972–4.372, p = 0.059).

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a decreasing trendno p-value reported
In terms of temporal distribution, the number of LUM/IVA-related reports remained high from 2016 to 2019 (with over 1,300 reports per year), but showed a decreasing trend starting since 2019 ( Figure 2A ).

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Quoted from the open-access full text in Europe PMC under the licence the publisher applied. The sentence is reproduced exactly as published; the emphasis is ours.