A review of the safety of Moxifloxacin Hydrochloride

12/1/99


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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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Author: Leonard Sacks