The analyses presented are exploratory in nature; confirmatory statistics were not carried out. For the present reporting, filters were applied to

highlight incidence rates and numerical differences between groups. These are explicitly stated in the titles and/or captions of each table or figure. Although somewhat arbitrary, these filters were always set at a low value and were conservative to avoid missing potentially important signals. Highlighted differences were interpreted on the basis https://www.selleckchem.com/products/Cediranib.html of the actual number of patients involved in the comparison. Unless stated otherwise, data are presented overall for the double-blind and the open-label studies, but separate reporting is available in the SDC. Results

Population and Comparator Antibiotics Table I shows the number of patients valid for the safety analysis who received moxifloxacin (n = 14 981) or comparator treatment (n = 15 023) by the oral, intravenous, or intravenous/oral routes, stratified by study design (double blind or open label). Approximately 75% of patients were enrolled in the double-blind studies. The percentage of patients with intravenous and intravenous/oral (sequential) treatments (29%) is substantially higher than that currently seen in clinical practice but reflects the design of studies and the severity of the studied indications. The choice of comparator(s) and dosage is consistent with standard therapies for the respective indications at HM781-36B the time each study was conducted. Table I Distribution of patients valid for the safety analysis, stratified by route of administration (oral only; intravenous followed by oral [sequential]; intravenous only) and by comparator Demographics Table II shows the demographics of the population analyzed (total = 30 004: see table SDC-II for stratification between

double-blind and open-label studies). There was no meaningful difference between the patients receiving moxifloxacin and those receiving a comparator with respect to age, sex, BMI, race, indications, and pre-existing risk factors (renal or hepatic impairment, diabetes mellitus, cardiac disorders, or low Carbohydrate BMI). Overall, the distribution of patients among the different indications mirrors the current prescribing patterns and clinical usage.[19,29] The majority of patients receiving oral moxifloxacin were treated for respiratory tract infections,[66] whereas patients receiving intravenous or intravenous/oral therapy (i) were older; (ii) were predominantly treated for CAP, cIAI and cSSSI; and (iii) had a higher incidence of pre-existing risk factors (related to the severity of their infection and their age).