Table 1.

Definitions of study end points

Primary end point

Overall survival

Number of days from date of treatment initiation to date of death. Death will be verified by sites based on death certificates or via caregiver, relative, or health care provider, and death information source will be captured in data collection. Surviving patients will be censored from last date of treatment assessment.

Secondary end points

Disease progression

Number of patients by treatment intervention with MRI/CT evidence of visible arterial enhancement, radiologic report of progression, or radiologic report of new tumor growth or symptomatic/clinical progression.

Time to disease progression

Number of days from date of treatment initiation to date of documented disease recurrence based on MRI or CT by treatment intervention, or symptomatic/clinical progression. Patients without recurrence will be censored from last date of treatment assessment.

Complication rate

Number of patients by treatment intervention who were withdrawn due to adverse events prior to introduction of other therapy.

Time to treatment-limiting adverse events

Number of days from first date of treatment to date of withdrawal due to adverse event(s) prior to introduction of other therapy. Patients without treatment-limiting adverse events will be censored at last date of treatment assessment.

Treatment failure rate

Number of patients by treatment intervention with a finding of treatment switch, HCC-related hospitalization and emergency room visit, disease recurrence, or death prior to introduction of other therapy.

Time to treatment failure

Number of days to first treatment failure overall and by individual item. Patients without treatment failure will be censored from last date of treatment assessment.

CT, computed tomography; MRI, magnetic resonance imaging.