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World J Gastroenterol. Aug 28, 2014; 20(32): 11384-11393
Published online Aug 28, 2014. doi: 10.3748/wjg.v20.i32.11384
Published online Aug 28, 2014. doi: 10.3748/wjg.v20.i32.11384
Table 3 Adverse events (with > 5% incidence) possibly related to treatment observed at the end of the phase II study and in the follow-up study n (%)
Timeline | Week-48 | Week-60 | Week-102 | Week-156 |
End of phase II study | 3 mo into follow-up study | 1 yr into follow-up study | End of follow-up study | |
MedDRA system | ||||
Blood and lymphatic system disorders: Thrombocytopenia | ||||
Group B: 160 mg/d | 2 (4.2) | 2 (4.2) | 2 (4.2) | 0 (0.0) |
Group C: 250 mg/d | 3 (6.7) | 3 (6.7) | 3 (6.7) | 3 (6.7) |
P-value1 | 0.671 | 0.671 | 0.671 | 0.109 |
Investigations; elevated ALT/elevated AST | ||||
Group B: 160 mg/d | 2 (4.2)/3 (6.3) | 2 (4.2)/3 (6.3) | 2 (4.2)/1 (2.1) | 1 (2.1)/0 (0.0) |
Group C: 250 mg/d | 7 (15.6)/7 (15.6) | 7 (15.6)/7 (15.6) | 2 (4.4)/1 (2.2) | 1 (2.2)/1 (2.2) |
P-value1 | 0.0843/0.1893 | 0.0843/0.1893 | 1.0000/1.0000 | 1.0000/0.4839 |
- Citation: Liu CJ, Chang J, Lee PH, Lin DY, Wu CC, Jeng LB, Lin YJ, Mok KT, Lee WC, Yeh HZ, Ho MC, Yang SS, Yang MD, Yu MC, Hu RH, Peng CY, Lai KL, Chang SSC, Chen PJ. Adjuvant heparanase inhibitor PI-88 therapy for hepatocellular carcinoma recurrence. World J Gastroenterol 2014; 20(32): 11384-11393
- URL: https://www.wjgnet.com/1007-9327/full/v20/i32/11384.htm
- DOI: https://dx.doi.org/10.3748/wjg.v20.i32.11384