Statement: A total of 3 patients in the primary trial suffered a life-threatening reaction to an infection.
Primary_evidence: Adverse Events 1:   Total: 9/90 (10.00%)   Febrile neutropenia 2/90 (2.22%)   Ascites 0/90 (0.00%)   Nausea 0/90 (0.00%)   Vomiting 0/90 (0.00%)   Death NOS 1/90 (1.11%)   Fever 0/90 (0.00%)   Other general disorders, administration site conditions 0/90 (0.00%)   Other hepatobiliary disorders 1/90 (1.11%)   Lung infection 2/90 (2.22%)   Sepsis 2/90 (2.22%)   Spinal fracture 0/90 (0.00%) Adverse Events 2:   Total: 12/89 (13.48%)   Febrile neutropenia 0/89 (0.00%)   Ascites 1/89 (1.12%)   Nausea 1/89 (1.12%)   Vomiting 1/89 (1.12%)   Death NOS 2/89 (2.25%)   Fever 1/89 (1.12%)   Other general disorders, administration site conditions 1/89 (1.12%)   Other hepatobiliary disorders 0/89 (0.00%)   Lung infection 0/89 (0.00%)   Sepsis 1/89 (1.12%)   Spinal fracture 1/89 (1.12%)