- Poster presentation
- Open Access
Dalbavancin safety in the phase 2/3 clinical development program
© BioMed Central Ltd 2008
- Published: 13 March 2008
- Vital Sign
- Median Duration
- Pharmacokinetic Profile
Dalbavancin (DAL) is a novel, next-generation lipoglycopeptide with a pharmacokinetic profile that allows weekly dosing. The safety of DAL in the treatment of complicated skin and soft tissue infections was demonstrated versus comparators (COMP) in the phase 2/3 clinical development program.
Safety was assessed by analyzing adverse events (AEs), laboratory parameters, vital signs, and ECGs. Safety analyses were conducted on the intent-to-treat (ITT) population, using descriptive statistics only (consistent with ICH Guidance). COMP included linezolid, cefazolin, and vancomycin.
Dalbavancin is a well-tolerated lipoglycopeptide, with an AE profile similar to comparators in type and duration of AEs.
This article is published under license to BioMed Central Ltd.