Table of Contents
A review of the safety of Moxifloxacin Hydrochloride
Moxifloxacin safety review
Patients valid for safety (worldwide)
Drug related adverse events occurring in >= 3% of patients treated with Moxifloxacin or comparator agents
Quinolone related toxicities
Treatment-emergent abnormally elevated liver function tests
Patients with a ?2 fold increase in AST ALT and BR (and at least ASTɯULN or ALTɯULN or BRɭ.5ULN)
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Moxifloxacin safety review
In vitro models
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Mean prolongation of QTc
Definition of outliers
Outlier shift analysis (Phase 1 and 2 studies)
Cardiac adverse events (Phase 1 &2)
ECG protocol
Patients with ECGs
ECGs excluded
Mean changes of QTcB (QT) in mS for patients with valid paired ECGs
Outlier shift analysis (Phase 3 studies)
Extreme outliers in phase 3 trials
Effect of hypokalemia on QTc prolongation
Cardiac adverse events
Summary
Moxifloxacin Question 1
Moxifloxacin Question 2
Moxifloxacin Question 3
Moxifloxacin Question 4
Extract from Label
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