Barely Significant
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Quantitative benefit-risk assessment of data from the phase III ClarIDHy study of ivosidenib versus placebo in patients with m<i>IDH1</i> cholangiocarcinoma.

ESMO Gastrointest Oncol · 2025 · PMC12836708 · PMID 41646284

1
hedged sentence
0.0600
closest p · 1.2× alpha
0.0600
boldest claim

The sentences

showed a trendP = 0.060so close (0.05 < p ≤ 0.1)
4 In addition, in the ClarIDHy study, treatment with ivosidenib showed a trend for improved overall survival (OS) compared with placebo (HR = 0.69; 95% CI 0.44–1.10; P = 0.060; median OS 10.8 months versus 9.7 months, respectively), which was considered significant after adjusting for patient crossover from placebo to ivosidenib using the rank-preserving structural failure ti

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