TABLE 2.

Attrition of patient populations in the study

PopulationaNo. of patients in amoxicillin-clavulanate treatment group:
2,000/125 mg875/125 mg
ITT population (safety population)322311
    Protocol violation(56)(69)
Clinical PP end of therapy266242
    Protocol violation(19)(16)
Clinical PP test of cure247226
ITT population (safety population)322311
    No typical pathogen isolated(235)(238)
Bacteriology ITT8773
    Protocol violation(13)(16)
Bacteriology PP end of therapy7457
    Protocol violation(7)(6)
Bacteriology PP test of cure6751
  • a The most common protocol violations for exclusion from the clinical per protocol (PP) population were no community-acquired pneumonia lack of visit compliance, indeterminate clinical assessment, lack of study medication compliance, and concomitant medication violation. The most common protocol violations for exclusion from the bacteriology per protocol population were lack of visit compliance, indeterminate bacteriological and/or clinical assessment, concomitant medication violation, lack of study medication compliance and complicating infections. ITT, intent to treat.