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Table 13. Serious Adverse Events Over Part 1 and Part 2

Part 1 Part 2
Treatment Control All Patients All Patients
(270) (280) (550) (347)
Subjects Events Subjects Events Subjects Events Subjects Events
Acute bronchitis 1 1 4 4 5 5 2 2
Bacteremia 1 1 3 5 4 6 2 2
Upper respiratory infection 2 2 2 2 4 4 1 1
Influenza 3 3 0 0 3 3 0 0
Cellulitis of leg 0 0 2 2 2 2 0 0
Cellulitis of legs 0 0 2 2 2 2 0 0
Central line infection 0 0 2 2 2 2 2 2
Endocarditis 0 0 2 2 2 2 0 0
Foot infection 2 3 0 0 2 3 0 0
Gastroenteritis 2 3 0 0 2 3 3 3
Incision site infection 1 3 1 4 2 7 1 1
Infection 0 0 2 2 2 2 1 1
Osteomyelitis 1 1 1 1 2 2 1 1
Pyelonephritis 1 1 1 1 2 2 0 0
Respiratory infection 1 1 1 1 2 2 0 0
Viral gastroenteritis 1 1 1 1 2 2 0 0
Abscess 1 1 0 0 1 1 0 0
Acute diverticulitis 1 1 0 0 1 1 0 0
Acute pyelonephritis 0 0 1 1 1 1 0 0
Bacterial endocarditis 0 0 1 1 1 1 0 0
Bacterial infection 1 1 0 0 1 1 0 0
C.difficile colitis 1 1 0 0 1 1 0 0
Catheter site infection 0 0 1 1 1 1 0 0
Cellulitis of arm 0 0 1 1 1 1 0 0
Cellulitis of hand 1 1 0 0 1 1 0 0
Clostridium difficile infection 1 1 0 0 1 1 0 0
Community acquired pneumonia 0 0 1 1 1 1 1 1
Diverticulitis 1 1 0 0 1 1 2 2
Gastritis viral 0 0 1 1 1 1 0 0
Gastroenteritis adenovirus 1 1 0 0 1 1 0 0
Groin abscess 1 1 0 0 1 1 0 0
HIV-related dementia 0 0 1 1 1 1 0 0
Infection MRSA 0 0 1 1 1 1 0 0
Infection NOS 0 0 1 1 1 1 1 1
Klebsiella bacteremia 1 1 0 0 1 1 0 0
Maxillary sinusitis 1 1 0 0 1 1 0 0
Methicillin-resistant staphylococcal aureus 0 0 1 1 1 1 0 0
sepsis
Obstructive pneumonia 1 1 0 0 1 1 0 0
Otitis media 0 0 1 1 1 1 0 0
Pneumonia MRSA 1 1 0 0 1 1 0 0
Prostatitis Escherichia coli 0 0 1 1 1 1 0 0
Purulent bronchitis 0 0 1 1 1 1 0 0
Salmonella infection, unspecified 0 0 1 1 1 1 0 0
Sepsis MRSA 0 0 1 1 1 1 1 2
Septic shock 0 0 1 1 1 1 3 3
Septicemia 0 0 1 1 1 1 0 0
Septicemia staphylococcal 0 0 1 1 1 1 0 0
Serratia infection 0 0 1 1 1 1 0 0
Sinusitis 0 0 1 1 1 1 1 1
Staphylococcal infection 1 1 0 0 1 1 0 0
Urosepsis 1 1 0 0 1 1 0 0
Viral infection 1 1 0 0 1 1 1 1
Viremia 0 0 1 1 1 1 0 0

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