Table VII Incidence of selected treatment-emergent adverse events presented by Standard MedDRA Queries/Bayer MedDRA Queries and preferred terms in patients valid for the safety analysis, treated with moxifloxacin or a comparator and stratified

by route of administration (oral only; intravenous followed by oral [sequential]; intravenous only). Data are limited to events with an incidence ≧0.5% in either group of patients. A single asterisk (*) indicates differences observed between groups that were ≥2.5% for events with an incidence ≥2.5% in both groups or ≥2-fold for events with an incidence <2.5% in one or both groups (calculations were made using the number of patients [no rounding]; in the event of a null value for one treatment, only situations where ≥2 cases were observed in NVP-HSP990 in vitro the other treatment group are indicated); the symbol is placed to the right of the value observed for the drug in disfavor. A double asterisk (**) indicates differences observed between treatment groups according to the same rule and where the number of patients experiencing an event was ≥10 in either group; the symbols are placed to the right of the

value observed for the drug in disfavor Drug-Related Hepatic Disorders – Comprehensive Search (Standard MedDRA Query [SMQ]) The overall incidences of the SMQs (AEs) designated as drug-related hepatic disorders in oral, intravenous/oral, and check details intravenous-only ARRY-438162 research buy studies were similar in the moxifloxacin and comparator treatment groups, though in the oral studies more cases of abnormal hepatic function were observed in the moxifloxacin-treated patients. Four cases of hepatic failure were experienced

in total, of which BCKDHB two due to the study drug occurred in moxifloxacin-treated patients and one occurred in a comparator-treated patient: with moxifloxacin, patient ♯1 (treated by the intravenous/oral routes for CAP) had a medical history of hepatitis C, alcohol abuse, and intravenous drug abuse, and developed acute hepatic failure after 2 days of therapy in the context of multi-organ failure with fatal outcome; patient ♯2 (treated orally for CAP) had a medical history of chronic hepatitis and developed hepatic failure after 4 days of therapy, which resolved spontaneously without discontinuation of the study drug; with the comparator, the patient (treated orally with levofloxacin for uncomplicated UTI) had no relevant medical history findings and developed hepatic failure 1 day after the study drug was stopped, which resolved spontaneously. Severe Cutaneous Adverse Reactions (SMQ) These were very rare and were reported with similar incidences in the moxifloxacin and comparator groups, with most events being non-serious (including conjunctivitis and stomatitis cases). One case of Stevens–Johnson syndrome (an ADR) was reported in a moxifloxacin-treated patient enrolled in a PID study.