Statement: One patient in the primary trial suffered from sepsis, due to the presence of an implanted device.
Primary_evidence: Adverse Events 1:   Total: 7/113 (6.19%)   Febrile neutropenia 1/113 (0.88%)   Neutropenia 1/113 (0.88%)   Anaemia 0/113 (0.00%)   Pancytopenia 1/113 (0.88%)   Proctitis 1/113 (0.88%)   Device related sepsis 1/113 (0.88%)   Gastrointestinal infection 0/113 (0.00%)   Injection site abscess 1/113 (0.88%)   Tooth infection 0/113 (0.00%)   Hip fracture 0/113 (0.00%)   Blood creatinine increased 1/113 (0.88%) Adverse Events 2:   Total: 6/112 (5.36%)   Febrile neutropenia 2/112 (1.79%)   Neutropenia 1/112 (0.89%)   Anaemia 1/112 (0.89%)   Pancytopenia 0/112 (0.00%)   Proctitis 0/112 (0.00%)   Device related sepsis 0/112 (0.00%)   Gastrointestinal infection 1/112 (0.89%)   Injection site abscess 0/112 (0.00%)   Tooth infection 1/112 (0.89%)   Hip fracture 1/112 (0.89%)   Blood creatinine increased 0/112 (0.00%)