- Patients who had participated in a previous sorafenib study that had completed, who
did not meet withdrawal criteria of the previous study and who were, in the opinion
of the investigator and sponsor still benefiting from treatment.
- The current cardiovascular situation of the patient was carefully re-evaluated by
both the investigator and the sponsor and an informed decision as to inclusion was
- Substance abuse, medical, psychological or social conditions that may have interfered
with the patient's participation in the study or evaluation of the study results.
- Known or suspected allergy to the investigational agent.
- Any condition that was unstable or which could jeopardise the safety of the patient
and his/her compliance in the study.