Adjuvant heparanase inhibitor PI-88 therapy for hepatocellular carcinoma recurrence

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

¹Fisher’s exact test. Treatment-related adverse events that were observed only in the phase II study are excluded. All adverse events in the 160 mg/d treatment group reverted to baseline levels by the end of the follow-up study. Adverse events were more frequently observed in the 250 mg/d treatment group. ALT: Alanine aminotransferase; AST: Aspartate aminotransferase.