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SEC Filings

8-K
BEIGENE, LTD. filed this Form 8-K on 01/07/2019
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Tislelizumab Phase 1 Common AEs in ≥ 10% of Patients System Organ Class Preferred Term Phase 1a Phase 1b Total N=116 n (%) N=335 n (%) N=451 n (%) Patients with at least one TEAE 114 (25.3) 322 (71.4) 436 (96.7) Fatigue 47 (10.4) 78 (17.3) 125 (27.7) Nausea 41 (9.1) 68 (15.1) 109 (24.2) Decreased appetite 19 (4.2) 71 (15.7) 90 (20.0) Diarrhea 32 (7.1) 49 (10.9) 81 (18.0) Constipation 26 (5.8) 50 (11.1) 76 (16.9) Abdominal pain 26 (5.8) 38 (8.4) 64 (14.2) Vomiting 20 (4.4) 43 (9.5) 63 (14.0) Back pain 22 (4.9) 40 (8.9) 62 (13.7) Cough 15 (3.3) 45 (10.0) 60 (13.3) Rash 23 (5.1) 37 (8.2) 60 (13.3) Dyspnea 12 (2.7) 33 (7.3) 45 (10.0) All grades, regardless of causality; Data cut - off 27 April 2018; 6 months after Last Patient Enrolled; Source: BGB - A317 IB v6.0 Of the 451 total patients in the Safety Population for Study BGB A317_001, 203 (45.0%) experienced at least 1 Grade 3 or high er TEAE. The most commonly occurring Grade 3 or higher TEAEs (≥ 2%; 9 or more patients overall incidence) were pneumonia (22 patients, 4.9%), a nem ia (18 patients, 3.2%), and hypokalemia (9 patients, 2.0%). 42

 


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