5 and 2. ABS = acute bacterial sinusitis; ADR = adverse drug reaction;

AE = adverse event; AECB = acute exacerbation of chronic bronchitis; CAP = community-acquired pneumonia; cIAI = complicated intra-abdominal RG-7388 manufacturer infection; cSSSI = complicated skin and skin structure infection; IV = intravenous; PO = oral; SADR = serious ADR; SAE = serious AE; uPID = uncomplicated pelvic inflammatory disease. Patients with Co-Morbidities Because the safety of drugs can be adversely influenced by the patient status and may also worsen it, data were also stratified according to the main pertinent co-morbidities and elimination pathway disorders observed in the population – namely age, diabetes mellitus, renal impairment, hepatic impairment, cardiac disorders, and abnormally low BMI. First, patients were stratified by study design (double blind and open label) and administration route (oral, intravenous/oral, intravenous), and the results are presented in table VIII. To better apprehend potentially meaningful differences, relative risk estimates (moxifloxacin versus comparator) were then calculated for each patient group stratified according to the administration route. The results are presented graphically in figures 2 and 3. On the basis of a threshold of a 2–fold increase

in risk estimates, the GSK1120212 molecular weight only difference seen in patients receiving oral treatment Carnitine palmitoyltransferase II was in those with underlying cardiac disorders (more AEs with fatal outcome for comparator) [figure 3b]; and the only differences seen in those receiving intravenous treatment were in those with (i) age ≥65 years (more ADRs with fatal outcome for comparator [figure 2a]); (ii) diabetes mellitus (more discontinuations due to ADRs for comparator [figure 2b]); (iii) hepatic impairment (more SADRs, discontinuation due to ADRs, and AEs with fatal outcome for moxifloxacin

[figure 3a]); (iv) cardiac disorders (more discontinuations due to AEs for moxifloxacin and more ADRs with fatal outcome for comparator [figure 3b]); and (v) BMI <18 kg/m2 (more discontinuations due to AEs or ADRs, and more AEs with fatal outcome for moxifloxacin [figure 3c]). However, numbers in the intravenous-only studies were small in all cases (1–7 patients). Lastly, the relative risk estimates (moxifloxacin versus comparator) were calculated after substratifying each group according to the comparator used, concentrating for each comparator on patients treated by the most frequent route of administration (if versus a β-lactam: oral, intravenous/oral and intravenous; if versus a macrolide alone: oral; if versus a β-lactam alone or a beta-lactam combined with a macrolide: intravenous/oral; if versus fluoroquinolone: intravenous only). The results are shown graphically in figures 4–6.