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- Figure 1.
Study Design: RECLAIM 1 and RECLAIM 2
APACHE, Acute Physiology and Chronic Health Evaluation; cIAI, complicated intra-abdominal infection; EOT, end of treatment; IV, intravenous; LFU, late follow-up; NI, noninferiority; TOC, test of cure.
aStratified by baseline severity of disease (APACHE II score) and region.
Reproduced with permission from JE Mazuski, MD.
- Figure 2.
Primary Efficacy Results
Solid line represents sponsor prespecified noninferiority margin of −12.5% for the lower limit of the 95% CI. Dashed line represents FDA requirement of −10%.
CAZ-AVI + MTZ, ceftazidime-avibactam plus metronidazole; CE, clinically evaluable; MER, meropenem; MITT, modified intention to treat; mMITT, microbiologically modified intention to treat; TOC, test of cure.
aEuropean Medicines Agency co–primary analysis population.
bFDA primary analysis population.
Reproduced with permission from JE Mazuski, MD.
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