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To collect the efficacy and safety information in subjects who have been treated with Zyvox (linezolid) for vancomycin resistance Enterococcus faecium infection for their appropriate use in daily practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zyvox (linezolid) | Patients who have been treated with Zyvox (linezolid). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zyvox (linezolid) | Drug | Patients should be treated with Zyvox (linezolid) 600 mg every twelve hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Drug Reactions. | All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported as adverse events. Definition of adverse drug reaction was treatment related adverse events which were evaluated in company with the causal relationship to the investigational product. | Baseline to 8 weeks |
| Number of Participants Categorized as Responders (Cure and Improved) to Zyvox (Linezolid) Treatment. | Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, laboratory test and investigator judgement, at the end of observation period. Clinical rating (cure/improved/not cured/unable to evaluate) was carried out. Definition of cured was disappearance of clinical symptom and/or Laboratory test abnormality. Definition of improved was improvement in clinical symptoms and/or laboratory test abnormality. | Baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Drug Reactions Unlisted in Japanese Package Insert. | The adverse drug reactions that have not been included in Japanese package insert. | Baseline to 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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The patients who are prescribed to Zyvox (linezolid).
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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This was a non-interventional retrospective study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Linezolid | Participants who have been treated with Zyvox (linezolid). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Linezolid | Participants who have been treated with Zyvox (linezolid). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Drug Reactions. | All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported as adverse events. Definition of adverse drug reaction was treatment related adverse events which were evaluated in company with the causal relationship to the investigational product. | Safety analysis population consisted of the participants that satisfied the inclusion and exclusion conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | Baseline to 8 weeks |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Linezolid | Participants who have been treated with Zyvox (linezolid). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Platelet count decreased | Investigations | MedDRA/J13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Platelet count decreased | Investigations | MedDRA/J13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Past medical history | Past medical history is the patient's past experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis or took from the participants. | Number | participants |
|
| Complications | Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.) | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Adverse Drug Reactions Unlisted in Japanese Package Insert. | The adverse drug reactions that have not been included in Japanese package insert. | Safety analysis population consisted of the participants that satisfied the inclusion and exclusion conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | Baseline to 8 weeks |
|
|
|
| Primary | Number of Participants Categorized as Responders (Cure and Improved) to Zyvox (Linezolid) Treatment. | Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, laboratory test and investigator judgement, at the end of observation period. Clinical rating (cure/improved/not cured/unable to evaluate) was carried out. Definition of cured was disappearance of clinical symptom and/or Laboratory test abnormality. Definition of improved was improvement in clinical symptoms and/or laboratory test abnormality. | The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated. | Posted | Number | participants | Baseline to 8 weeks |
|
|
|
| 9 |
| 41 |
| 21 |
| 41 |
| White blood cell count decreased | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA/J13.1 | Systematic Assessment |
|
| Histiocytosis haematophagic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J13.1 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA/J13.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
| Superinfection | Infections and infestations | MedDRA/J13.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA/J13.1 | Systematic Assessment |
|
| Histiocytosis haematophagic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J13.1 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|
|
| Liver disorder |
|
| Renal disorder |
|
| Multi-organ failure |
|