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Drug use investigation of Zyvox for patients with Methicillin-resistant Staphylococcus aureus (MRSA) infection disease.
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Package Insert (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
All the patients whom an investigator prescribes the first Linezolid should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| linezolid (Zyvox) | Patients taking Linezolid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| linezolid (Zyvox) | Drug | Zyvox Tablets 600mg, Zyvox Injection 600mg Dosage, Frequency: According to Japanese Package Insert, In adults, administer usually 600mg of linezolid twice daily (q 12 hours) for a total daily dose of 1200 mg. Duration: According to the protocol of A5951142, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 8 weeks after the first administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. | The adverse drug reaction that have not been listed in Japanese package insert. | Baseline to 8 weeks |
| Number of Participants With Adverse Drug Reactions(ADRs). | All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Adverse Drug Reactions were evaluated in company with the causal relationship to the investigational product. | 8 weeks |
| Factors Considered to Affect the Safety of Linezolid - Gender. | Number of participants with adverse drug reaction to determine whether male or female is significant risk factor. | 8 weeks |
| Factors Considered to Affect the Safety of Linezolid - Age | Number of participants with adverse drug reaction to determine whether over 65 or less than 65 is significant risk factor. | 8 weeks |
| Factors Considered to Affect the Safety of Linezolid - Hepatic Dysfunctions. | Number of participants with or without Hepatic dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor. | 8 weeks |
| Factors Considered to Affect the Safety of Linezolid - Renal Dysfunctions. | Number of participants with or without Renal dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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The patients whom an investigator involving A5951142 prescribes the Linezolid.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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This was an open label, prospective, multi-center non-interventional cohort study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Linezolid | Participants who have been treated with Linezolid. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Linezolid | Participants who have been treated with 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 Reaction Not Expected From the Japanese Package Insert. | The adverse drug reaction that have not been listed in Japanese package insert. | Safety analysis population consists of the participants that satisfy 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 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 |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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|
| Factors Considered to Affect the Safety of Linezolid - Duration of Drug Administration. | Number of participants with Duration of drug administration as over 15 days or less than 15 days with adverse drug reaction to determine whether over 15 days or less than 15 days is significant risk factor. | 8 weeks |
| Factors Considered to Affect the Safety of Linezolid - Route of Administration. | Number of participants Route of administration as by oral,injection or oral from injection with adverse drug reaction to determine whether oral, injection or switch is significant risk factor. | 8 weeks |
| Factors Considered to Affect the Safety of Linezolid - Weight. | Number of participants Weight as over 40kg or less than 40kg with adverse drug reaction to determine whether over 40kg or less than 40kg Weight is significant risk factor. | 8 weeks |
| Factors Considered to Affect the Safety of Linezolid - Concomitant Drugs. | Number of participants with or without Concomitant drugs with adverse drug reaction to determine whether with or without is significant risk factor. | 8 weeks |
| Factors Considered to Affect the Safety of Linezolid - Non-drug Therapies. | Number of participants with or without Non-drug therapies with adverse drug reaction to determine whether with or without is significant risk factor. | 8 weeks |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Target disease | The physician in charge of the study made the diagnosis of Target disease based on symptoms. | Number | participants |
|
| Target disease Severity | 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 |
|
|
| Primary | Number of Participants With Adverse Drug Reactions(ADRs). | All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Adverse Drug Reactions were evaluated in company with the causal relationship to the investigational product. | Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
| Primary | Factors Considered to Affect the Safety of Linezolid - Gender. | Number of participants with adverse drug reaction to determine whether male or female is significant risk factor. | Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
|
| Primary | Factors Considered to Affect the Safety of Linezolid - Age | Number of participants with adverse drug reaction to determine whether over 65 or less than 65 is significant risk factor. | Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
|
| Primary | Factors Considered to Affect the Safety of Linezolid - Hepatic Dysfunctions. | Number of participants with or without Hepatic dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor. | Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
|
| Primary | Factors Considered to Affect the Safety of Linezolid - Renal Dysfunctions. | Number of participants with or without Renal dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor. | Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
|
| Primary | Factors Considered to Affect the Safety of Linezolid - Duration of Drug Administration. | Number of participants with Duration of drug administration as over 15 days or less than 15 days with adverse drug reaction to determine whether over 15 days or less than 15 days is significant risk factor. | Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
|
| Primary | Factors Considered to Affect the Safety of Linezolid - Route of Administration. | Number of participants Route of administration as by oral,injection or oral from injection with adverse drug reaction to determine whether oral, injection or switch is significant risk factor. | Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
|
| Primary | Factors Considered to Affect the Safety of Linezolid - Weight. | Number of participants Weight as over 40kg or less than 40kg with adverse drug reaction to determine whether over 40kg or less than 40kg Weight is significant risk factor. | Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
|
| Primary | Factors Considered to Affect the Safety of Linezolid - Concomitant Drugs. | Number of participants with or without Concomitant drugs with adverse drug reaction to determine whether with or without is significant risk factor. | Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
|
| Primary | Factors Considered to Affect the Safety of Linezolid - Non-drug Therapies. | Number of participants with or without Non-drug therapies with adverse drug reaction to determine whether with or without is significant risk factor. | Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
|
| 50 |
| 970 |
| 163 |
| 970 |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | 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 |
|
| Haematocrit decreased | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA/J13.1 | Systematic Assessment |
|
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA/J13.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Superinfection | Infections and infestations | MedDRA/J13.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
| Pneumonia klebsiella | Infections and infestations | MedDRA/J13.1 | Systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA/J13.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA/J13.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Agitation | Nervous system disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA/J13.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
| Antithrombin III decreased | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
| Blood chloride increased | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
| Blood sodium increased | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA/J13.1 | Systematic Assessment |
|
| Reticulocyte 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 |