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SEC Filings

8-K
BEIGENE, LTD. filed this Form 8-K on 01/07/2019
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▪ Very low rates of headache and hypertension (6.7% and 6.3%) ▪ Concomitant use of vitamin K antagonists was allowed in these zanubrutinib trials ▪ Paucity of treatment discontinuation for adverse events Adverse Events of Interest for BTK Inhibitors in Patients Treated with Zanubrutinib *Resulting in one death: intraparenchymal CNS haemorrhage AE of Interest (All Causes) Zanubrutinib (Including Patients Enrolled in Combo Studies) Patient Number N=641 Mean Exposure Time 7.7 mo Atrial Fibrillation 1.7% Major Hemorrhage 1.9% AE of Interest (All Causes) Zanubrutinib (Single Agent Only) Patient Number N=476 Median Exposure Time 7.0 mo Atrial Fibrillation ( Gr ≥3 ) 2% ( 0.2%, total one Gr3 case) Major Hemorrhage* 2% Diarrhea ( Gr ≥3 ) 14% (0.8%, total four G3 cases) 31 Zanubrutinib Safety and Tolerability Summary; Over 600 - Patient Experience Major hemorrhage includes serious or grade ≥3 bleeding of any site, or central nervous system bleeding of any grade. Source: pooled safety analysis of ongoing zanubrutinib clinical trials, data cut - off September 2017, n=641; Seymour, ICML 2017; Tam et, al., EHA 2018

 


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