9% versus comparator 6.2% [oral], moxifloxacin 7.3% versus comparator 6.3% [intravenous/oral], R406 moxifloxacin 5.4% versus comparator 3.5% [intravenous]); headache (moxifloxacin 5.6% versus comparator 5.9% [intravenous/oral]); constipation (moxifloxacin 7.7% versus comparator 6.1% [intravenous/oral]); hypokalemia (moxifloxacin 5.1% versus comparator 5.0% [intravenous/oral]); and insomnia (moxifloxacin 7.2% versus comparator 7.2% [intravenous/oral]). Reported AEs with ≥5% incidence for patients enrolled in open-label studies included diarrhea (moxifloxacin 3.6% versus comparator

7.4% [oral], moxifloxacin 6.1% versus comparator 6.5% [intravenous/oral]) and nausea (moxifloxacin 5.1% versus comparator 2.4% [oral]). Again limiting the description to selleck inhibitor situations where (i) there was a 2-fold difference between

treatment arms for events Cell Cycle inhibitor with an incidence <2.5% in either of the treatment groups or a ≥2.5% difference between treatments for events with an incidence ≥2.5% in both groups, and (ii) the number of patients experiencing an event was ≥10 in either treatment group, the following differences were noted in disfavor of moxifloxacin in the double-blind studies: (i) for patients treated with oral therapy (moxifloxacin 8822 versus comparator 8643): hyperhidrosis (36 [0.4%] versus 16 [0.2%]), tremor (35 [0.4%] versus 15 [0.2%]), atrial fibrillation (16 [0.2%] versus 3 [<0.1%]), and pleural effusion (12 [0.1%] versus 5 [<0.1%]); (ii) for patients treated with intravenous/oral therapy (moxifloxacin 1889 versus comparator 1856): incision site pain (21 [1.1%] versus 10 [0.5%]), erythema (19 [1.0%] versus 6 [0.3%]), hypophosphatemia (16 [0.8%] versus 3 [0.2%]), depression (15 [0.8%] versus 4 [0.2%]), increase in white blood cell (WBC) count (11 [0.6%] versus 5 [0.3%]), and increase in lactate dehydrogenase (LDH; 10 [0.5%] versus 4 [0.2%]); and (iii) in patients treated by the intravenous route (moxifloxacin 588 versus comparator 571): insomnia (11 [1.9%] versus 3 [0.5%]) these and abdominal pain (10 [1.7%] versus 1 [0.2%]). Conversely, and with the same double filter, the following AEs were more frequently reported in the comparator group: (i) in oral studies:

dysgeusia (moxifloxacin 74 [0.8%] versus comparator 179 [2.1%]), increase in gammaglutamyl transferase (GGT; moxifloxacin 20 [0.2%] versus comparator 41 [0.5%]), muscle spasms (moxifloxacin 12 [0.1%] versus comparator 25 [0.3%]), and myocardial infarction (moxifloxacin 2 [<0.1%] versus comparator 12 [0.1%]); and (ii) in intravenous/oral studies: cough (moxifloxacin 7 [0.4%] versus comparator 15 [0.8%]), myocardial infarction (moxifloxacin 5 [0.3%] versus comparator 10 [0.5%]), musculoskeletal pain (moxifloxacin 3 [0.2%] versus comparator 10 [0.5%]), and leukocytosis (moxifloxacin 2 [0.1%] versus comparator 10 [0.5%]). In the open-label studies, the most common AEs in disfavor of moxifloxacin were nausea (in oral studies: moxifloxacin 91 [5.1%] versus comparator 50 [2.