Zyvox™ (linezolid) Tablets, injection, suspension

3/28/00


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Table of Contents

Zyvox™ (linezolid) Tablets, injection, suspension

Overview

Clinical pharmacology: Pharmacokinetics

Clinical pharmacology: Pharmacokinetics

Clinical pharmacology: Metabolism and excretion

Efficacy Analyses

Clinical studies

Differences in outcome assessment

Analytic populations

Community-acquired pneumonia

Community-acquired pneumonia (Study 33)

Study 33 (Inpatient CAP) Demographics

Study 33 (inpatient CAP) Patient populations

Study 33 (inpatient CAP) Clinical efficacy results

Study 33 (inpatient CAP) 95% confidence intervals

Study 33 (inpatient CAP) Results by pathogen (ME patients)

Study 33 (inpatient CAP) Subgroup analyses (CE patients)

Study 33 (inpatient CAP) Effect of missing data

Community-acquired pneumonia (Study 51)

Study 51 (Outpatient CAP) Demographics

Study 51 (outpatient CAP) Patient populations

Study 51 (outpatient CAP) Clinical efficacy results

Study 51 (outpatient CAP) 95% confidence intervals

Study 51 (outpatient CAP) Results by pathogen (ME patients)

Study 51 (outpatient CAP) Subgroup analyses (CE patients)

Study 51 (outpatient CAP) Effect of missing data

Hospital-acquired pneumonia

Hospital-acquired pneumonia (Study 48A)

Study 48A (HAP) Demographics

Study 48A (HAP) Patient populations

Study 48A (HAP) Clinical efficacy results

Study 48A (HAP) 95% confidence intervals

Study 48A (HAP) Results by pathogen (ME patients)

Study 48A (HAP) Subgroup analyses (ME patients)

Study 48A (HAP) Subgroup analyses (MITT patients)

Study 48A (HAP) Effect of missing data

Study 48A (HAP) Mortality rates

Uncomplicated skin and skin structure infections (uSSSI)

Study 39A/39 (uSSSI) Description

Study 39A (uSSSI) Demographics

Study 39A (uSSSI) Patient populations

Study 39A (uSSSI) Clinical efficacy results

Study 39A (uSSSI) 95% confidence intervals

Study 39A (uSSSI) Results by pathogen

Study 39A (uSSSI) Effect of missing data

Study 39 (uSSSI) Demographics

Study 39 (uSSSI) Patient populations

Study 39 (uSSSI) Clinical efficacy results

Study 39 (uSSSI) 95% confidence intervals

Study 39 (uSSSI) Results by pathogen

Complicated skin and skin structure infections (cSSSI)

Complicated skin/skin structure infections (Study 55)

Study 55 (cSSSI) Demographics

Study 55 (cSSSI) Patient populations

Study 55 (cSSSI) Clinical efficacy results

Study 55 (cSSSI) 95% confidence intervals

Study 55 (cSSSI) Results by pathogen

Study 55 (cSSSI) Subgroup analyses

Study 55 (cSSSI) Effect of missing data

Methicillin-resistant staphylococcal species (MRSS) infections

MRSS infections (Study 31)

Study 31 (MRSS) Demographics

Study 31 (MRSS) Patient populations

Study 31 (MRSS) Clinical efficacy results

Study 31 (MRSS) 95% confidence intervals

Study 31 (MRSS) Results by pathogen (ME patients)

Study 31 (MRSS) Results by pathogen (MITT patients)

Study 31 (MRSS) Outcome by site of MRSA infection (ME)

Study 31 (MRSS) Outcome by site of MRSA infection (MITT)

Study 31 (MRSS) Effect of missing data

Vancomycin-resistant enterococcal (VRE) infections

VRE infections (Study 54A)

Study 54A (VRE) Demographics

Study 54A (VRE) Patient populations

Study 54A (VRE) Efficacy results

Study 54A (VRE) Results by pathogen

Study 54A (VRE) Outcome by site of VRE infection

Covariate analyses

Study 54A (VRE) Effect of missing data

Study 54A (VRE) All-cause mortality rates

Causes of death in patients with VRE bacteremia

Covariate analysis of mortality in bacteremic patients

History: Studies 54A & 54

Study 54 (VRE) Efficacy results

Safety analysis

Adverse events

Adverse events

Drug-related adverse events

Discontinuations due to AEs

Discontinuations due to drug-related AEs

Discontinuations by adverse event

Discontinuations by drug-related AE

Laboratory findings

Comparator-controlled studies: Development of thrombocytopenia*

Comparator-controlled studies: Grade III thrombocytopenia*

Effect of linezolid dose on development of thrombocytopenia*

PPT Slide

Summary: thrombocytopenia in linezolid-treated patients

Drug-drug interactions

MAO inhibition

Linezolid-sympathomimetic amine interactions

Selected concomitant medications

Potential drug-drug interaction events

Linezolid resistance

Linezolid resistance

Linezolid resistance in clinical trials

Linezolid resistance in compassionate use trial (Study 25)

Linezolid resistance in dose-comparison trials

Linezolid Review Team

Author: TESCHNE1