Phase I/II Study of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma

Subjects With Treatment Emergent Adverse Events

Treatment emergent adverse events observed during outcome measure time frame.

Time frame: From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

Recommended Dose (RD) of OPB-31121 was defined as the highest dose at which Dose Limited Toxicity (DLT) occurred at an incidence of \< 30%. DLT was defined as adverse events related to OPB-31121 occurring until Day 32, and 1) Grade 4 neutrophil count decreased persisting for ≧ 8 days, or Grade 3 or 4 febrile neutropenia, or infection with neutrophil count decreased 2) Grade 4 Plt decreased, or Grade 3 Plt decreased persisting for ≧ 8 days 3) Grade 3 or 4 nausea, vomiting, or diarrhoea that occurred despite the use of an anti-emetic or anti-diarrheal agents 4) Grade 3 or more severe AEsa excluding the AEs presented above 1) to 3) 5) AEs requiring interruption of IMP administration for a period of ≧ 8 consecutive days 6) Same AEs causing interruption of IMP administration twice

Time frame: From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)