This subject had a history of varicose ulceration of a lower extremity before starting the study and experienced serious adverse events of lower left limb erysipelas, lower right limb skin ulcer, and lower right limb cellulitis over the course of the study, with the first event occurring on study day 39. One subject with a confirmed neuroendocrine carcinoma of OSI 906 pancreas experienced a fatal event associated with cellulitis of the right leg; the case was complicated

by sepsis, shock, and multiple organ failure (denosumab subject 5; Table 4). Gastrointestinal infections Serious adverse events of infections were also examined in more detail according to body system. Serious adverse events of infections involving the gastrointestinal system occurred in 28 (0.7%) placebo subjects and 36 (0.9%) denosumab subjects (Table 5). The preferred terms categorized under the gastrointestinal body system correspond to infections with heterogeneous etiology, and no consistent pattern was observed in the type of infections. For individual find more preferred terms, the difference between treatment groups was 0.1% or less. The most common events were gastroenteritis, diverticulitis, and appendicitis. Table 5 Incidence of serious adverse events of infections

related to the gastrointestinal, renal and urinary, and ear and labyrinth body systems   Placebo (N = 3,876)a, n (%) Denosumab (N = 3,886)a, n (%) P value Serious adverse events of infections related to the gastrointestinal system 28 (0.7) 36 (0.9) 0.3322  GS-1101 research buy gastroenteritis 7 (0.2) 9 (0.2)  Diverticulitis 6 (0.2) 8 (0.2)  Appendicitis 7 (0.2) 7 (0.2)  Abdominal abscess 0 (0) 2 (0.1)  Helicobacter infection 0 (0) 2 (0.1)  Clostridium difficile colitis 2 (0.1) 1 (<0.1)  Anal abscess 0 (0) 1 (<0.1)  Biliary tract infection fungal 0 (0) 1 (<0.1)

 Gastric infection PAK5 0 (0) 1 (<0.1)  Gastroenteritis Escherichia coli 0 (0) 1 (<0.1)  Gastroenteritis bacterial 0 (0) 1 (<0.1)  Gastroenteritis rotavirus 0 (0) 1 (<0.1)  Gastroenteritis viral 0 (0) 1 (<0.1)  Post procedural infection 0 (0) 1 (<0.1)  Salmonellosis 2 (0.1) 0 (0)  Abscess intestinal 1 (<0.1) 0 (0)  Gastrointestinal infection 1 (<0.1) 0 (0)  Infected cyst 1 (<0.1) 0 (0)  Peridiverticular abscess 1 (<0.1) 0 (0)  Peritoneal abscess 1 (<0.1) 0 (0)  Typhus 1 (<0.1) 0 (0) Serious adverse events of infections related to the renal and urinary systems 20 (0.5) 29 (0.7) 0.2105  Urinary tract infection 10 (0.3) 16 (0.4)  Cystitis 2 (0.1) 6 (0.2)  Pyelonephritis 2 (0.1) 5 (0.1)  Urosepsis 2 (0.1) 1 (<0.1)  Pyelonephritis acute 1 (<0.1) 1 (<0.1)  Pyelonephritis chronic 0 (0) 1 (<0.1)  Escherichia infection 2 (0.