Table 3. . Study end points.

Primary end point (overall success) criteria	Secondary end points
Overall success is defined as all of the following:	• All-cause mortality at day 70 (±5 days) in the mITT population • Microbiological eradication at day 70 (±5 days) in the mITT population • Overall success rate at day 70 (±5 days) in the CE population • Development of new metastatic foci or other complications of SAB after day 7 in the mITT population • Time to S. aureus bloodstream clearance in the mITT and CE populations • Safety and tolerability in the safety population, in terms of the incidence, type and severity of adverse events, and relationship to study medication, and changes in laboratory tests; and • Pharmacokinetics of ceftobiprole in the PK population
• Patient alive at day 70 (±5 days) postrandomization • No new metastatic foci or complications of the SAB infection† • Resolution or improvement of SAB-related clinical signs and symptoms • Two negative blood cultures for Staphylococcus aureus, with no subsequent positive blood culture for S. aureus   - ≥1 negative blood culture must be recorded while on active study treatment   - Cultures must be confirmed by ≥1 subsequent negative blood culture for S. aureus at day 70 (±5 days) or between 7 days after the EOT visit and day 70 (±5 days)
Treatment failure is defined as any of the following:
• Premature discontinuation of study treatment due to lack of efficacy (as judged by the CEC committee), or for adverse events representing disease progression or relapse • Development of new metastatic or other complications related to SAB between day 8 and PTE visit • SAB relapse or reinfection, based on evidence from a blood culture positive for S. aureus between EOT and PTE visits • Receipt of systemic nonstudy antibacterial treatments for SAB, other than those permitted under the protocol • Treatment of infections, other than SAB, with systemic nonstudy antibacterial treatment that is potentially effective against S. aureus and is considered by the CEC committee to have a relevant impact on the primary end point • Death for any reason • Indeterminate outcome (e.g., due to missing data, patients lost to follow-up or failure to meet the criteria for success or failure) • Requirement for longer systemic antibacterial treatment for SAB than is allowed by the protocol

^† Foci identified from day 8 onwards are considered to be new foci.

CE: Clinically evaluable; CEC: Clinical events classification; EOT: End-of-treatment; mITT: Modified intent-to-treat; PK: Pharmacokinetic; PTE: Post-treatment evaluation.

SAB: S. aureus bacteremia.