Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and also may not reflect rates observed in practice.<\/p>\n\n\n\n
ZERBAXA was evaluated in a Phase 3 comparator-controlled clinical trial for HABP\/VABP, which included a total of 361 patients treated with ZERBAXA (3 g every 8 hours, adjusted based on renal function where appropriate) and 359 patients treated with comparator (meropenem 1 g every 8 hours) for up to 14 days. The mean age of treated patients was 60 years (range 18 to 98 years), across treatment arms. About 44% of the subjects were 65 years of age or older. Most patients (71%) enrolled in the trial were male. All subjects were mechanically ventilated at randomization and 92% were in an intensive care unit (ICU) at randomization. The median APACHE II score was 17, and 33% of subjects had a baseline APACHE II score of \u226520, indicating a high severity of illness for many patients enrolled in this trial.<\/p>\n\n\n\n
The table below lists adverse reactions occurring in 2% or greater of patients receiving ZERBAXA in a Phase 3 HABP\/VABP clinical trial.<\/p>\n\n\n\n