Efficacy measured at the End of IV Treatment visit (FDA), or at the Test Of Cure visit (EMA). EOIVT at day 5 - 14 (FDA), TOC at day 15-23 (EMA) [clinicaltrials_resource:eb21d2bac80fe4a2042899069d14ccf1]
For the FDA: the proportion of subjects in the microbiologic Modified Intent To Treat Population (m-MITT) who achieve overall success at the EOIVT visit. Overall success is achieved with a clinical outcome of Cure or Improvement and microbiologic outcome of Eradication at EOIVT. Cure is defined as the complete resolution or significant improvement of the baseline signs and symptoms. Improvement is defined as lessening, incomplete resolution, or no worsening of the baseline signs and symptoms. Eradication is defined as the demonstration that the bacterial pathogen(s) found at baseline is reduced to <104 CFU/mL of urine.
For the European Medicines Agency (EMA): the proportion of subjects in the co-primary m-MITT and Microbiologic Evaluable (ME) Populations who achieve a microbiologic outcome of Eradication at the TOC visit. Eradication is defined as the demonstration that the bacterial pathogen(s) found at baseline is reduced to <103 CFU/mL of urine.
clinicaltrials_vocabulary:secondary outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:secondary-outcome]
Efficacy measured at the End of IV Treatment visit (FDA), or at the Test Of Cure visit (EMA). EOIVT at day 5 - 14 (FDA), TOC at day 15-23 (EMA) [clinicaltrials_resource:eb21d2bac80fe4a2042899069d14ccf1]
For the FDA: the proportion of subjects in the microbiologic Modified Intent To Treat Population (m-MITT) who achieve overall success at the EOIVT visit. Overall success is achieved with a clinical outcome of Cure or Improvement and microbiologic outcome of Eradication at EOIVT. Cure is defined as the complete resolution or significant improvement of the baseline signs and symptoms. Improvement is defined as lessening, incomplete resolution, or no worsening of the baseline signs and symptoms. Eradication is defined as the demonstration that the bacterial pathogen(s) found at baseline is reduced to <104 CFU/mL of urine.
For the European Medicines Agency (EMA): the proportion of subjects in the co-primary m-MITT and Microbiologic Evaluable (ME) Populations who achieve a microbiologic outcome of Eradication at the TOC visit. Eradication is defined as the demonstration that the bacterial pathogen(s) found at baseline is reduced to <103 CFU/mL of urine.
Bio2RDF identifier
eb21d2bac80fe4a2042899069d14ccf1
Bio2RDF namespace
clinicaltrials_resource
Bio2RDF uri
http://bio2rdf.org/clinicaltrials_resource:eb21d2bac80fe4a2042899069d14ccf1
measure [clinicaltrials_vocabulary:measure]
Efficacy measured at the End o ...... the Test Of Cure visit (EMA).
time frame [clinicaltrials_vocabulary:time-frame]
EOIVT at day 5 - 14 (FDA), TOC at day 15-23 (EMA)
description
For the FDA: the proportion of ...... duced to <103 CFU/mL of urine.
identifier
clinicaltrials_resource:eb21d2bac80fe4a2042899069d14ccf1
title
Efficacy measured at the End o ...... (FDA), TOC at day 15-23 (EMA)
@en
type
label
Efficacy measured at the End o ...... 1d2bac80fe4a2042899069d14ccf1]
@en