Table 3.
Category | Placebo Group |
|
---|---|---|
N | % | |
Subjects randomized to placebo arm | 4005 | |
Subjects given placebo | 3982 | |
Placebo recipients in the MITT population | 3832 | |
Patients with SA infections of any type or severity | 120 | 3.1 |
Patients with any invasive SA infections | 39 | 1.0 |
Patients with SA bacteremia and/or DSWI (primary endpoints) | 33 | 0.9 |
Patients with any SA SSI | 97 | 2.5 |
Specific infections (in alphabetical order) | n | % |
Aortic root abscess | 1 | <0.1 |
Bacteremia | 25 | 0.7 |
Deep incisional SSI at leg or arm donor/harvest site | 7 | 0.2 |
DSWI with mediastinitis | 10 | 0.3 |
DSWI without mediastinitis | 1 | <0.1 |
Endocarditis | 4 | 0.1 |
Noninvasive skin/soft tissue infection | 5 | 0.1 |
Osteomyelitis | 1 | <0.1 |
Pancreatic abscess | 1 | <0.1 |
Pneumonia | 9 | 0.2 |
Septic arthritis (knee prosthesis) | 1 | <0.1 |
Superficial incisional SSI at chest incision site | 26 | 0.7 |
Superficial incisional SSI at leg or arm donor/harvest site | 40 | 1.0 |
Superficial incisional SSI at catheter or tube insertion site | 8 | 0.2 |
Tracheobronchitis | 2 | <0.1 |
Urinary tract infection | 1 | <0.1 |
Abbreviations: DSWI, deep sternal wound infection; MITT, modified intention to treat; N, number of patients with the specified infection (% with specified infection); n, number of infections; SA, Staphylococcus aureus; SSI surgical site infection.
a Patients may have had multiple infections and be included in multiple categories.