Trial · NCT00666276

Drug Use Investigation Of Zyvox (Linezolid) (Regulatory Post Marketing Commitment Plan)

NCT00666276, Completed, Pfizer; results first posted 2012-07-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Drug Use Investigation Of Zyvox (Linezolid) (Regulatory Post Marketing Commitment Plan). Trials, record NCT00666276. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00666276

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Drug Use Investigation Of Zyvox (Linezolid) (Regulatory Post Marketing Commitment Plan)
NCT number: NCT00666276
Status: Completed
Enrollment: 1,004 participants, actual
Lead sponsor: Pfizer
Conditions: Staphylococcal Infections
Interventions: linezolid (Zyvox)
First posted: 2008-04-24
Last updated: 2012-07-02
Results first posted: 2012-07-02

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.	Baseline to 8 weeks	The adverse drug reaction that have not been listed in Japanese package insert.
Primary	Number of Participants With Adverse Drug Reactions(ADRs).	8 weeks	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.
Primary	Factors Considered to Affect the Safety of Linezolid - Gender.	8 weeks	Number of participants with adverse drug reaction to determine whether male or female is significant risk factor.
Primary	Factors Considered to Affect the Safety of Linezolid - Age	8 weeks	Number of participants with adverse drug reaction to determine whether over 65 or less than 65 is significant risk factor.
Primary	Factors Considered to Affect the Safety of Linezolid - Hepatic Dysfunctions.	8 weeks	Number of participants with or without Hepatic dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor.
Primary	Factors Considered to Affect the Safety of Linezolid - Renal Dysfunctions.	8 weeks	Number of participants with or without Renal dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor.
Primary	Factors Considered to Affect the Safety of Linezolid - Duration of Drug Administration.	8 weeks	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.
Primary	Factors Considered to Affect the Safety of Linezolid - Route of Administration.	8 weeks	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.
Primary	Factors Considered to Affect the Safety of Linezolid - Weight.	8 weeks	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.
Primary	Factors Considered to Affect the Safety of Linezolid - Concomitant Drugs.	8 weeks	Number of participants with or without Concomitant drugs with adverse drug reaction to determine whether with or without is significant risk factor.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.	Baseline to 8 weeks	Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.	participants	NUMBER
PRIMARY	Number of Participants With Adverse Drug Reactions(ADRs).	8 weeks	Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.	participants	NUMBER
PRIMARY	Factors Considered to Affect the Safety of Linezolid - Gender.	8 weeks	Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.	participants	NUMBER
PRIMARY	Factors Considered to Affect the Safety of Linezolid - Age	8 weeks	Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.	participants	NUMBER
PRIMARY	Factors Considered to Affect the Safety of Linezolid - Hepatic Dysfunctions.	8 weeks	Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.	participants	NUMBER
PRIMARY	Factors Considered to Affect the Safety of Linezolid - Renal Dysfunctions.	8 weeks	Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.	participants	NUMBER
PRIMARY	Factors Considered to Affect the Safety of Linezolid - Duration of Drug Administration.	8 weeks	Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.	participants	NUMBER
PRIMARY	Factors Considered to Affect the Safety of Linezolid - Route of Administration.	8 weeks	Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.	participants	NUMBER
PRIMARY	Factors Considered to Affect the Safety of Linezolid - Weight.	8 weeks	Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.	participants	NUMBER
PRIMARY	Factors Considered to Affect the Safety of Linezolid - Concomitant Drugs.	8 weeks	Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.	participants	NUMBER

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.	Linezolid	Superinfection	1	participants
Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.	Linezolid	Sepsis	1	participants
Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.	Linezolid	Thrombocytopenia	1	participants
Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.	Linezolid	Lactic acidosis	1	participants
Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.	Linezolid	Agitation	1	participants
Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.	Linezolid	Deep vein thrombosis	1	participants
Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.	Linezolid	Hyperbilirubinaemia	1	participants
Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.	Linezolid	Antithrombin III decreased	1	participants
Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.	Linezolid	Blood chloride increased	1	participants
Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.	Linezolid	Blood sodium increased	1	participants

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Linezolid	1,004
Overall Study	COMPLETED	Linezolid	970
Overall Study	NOT COMPLETED	Linezolid	34

Source ClinicalTrials.gov

Adverse events56

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Platelet count decreased	Investigations	Linezolid	78	970	78
other	Anaemia	Blood and lymphatic system disorders	Linezolid	31	970	31
other	Thrombocytopenia	Blood and lymphatic system disorders	Linezolid	26	970	26
other	White blood cell count decreased	Investigations	Linezolid	12	970	12
other	Bone marrow failure	Blood and lymphatic system disorders	Linezolid	8	970	8
other	Hepatic function abnormal	Hepatobiliary disorders	Linezolid	6	970	6
other	Superinfection	Infections and infestations	Linezolid	5	970	5
other	Diarrhoea	Gastrointestinal disorders	Linezolid	5	970	5
other	Pancytopenia	Blood and lymphatic system disorders	Linezolid	4	970	4
other	Rash	Skin and subcutaneous tissue disorders	Linezolid	4	970	4

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Linezolid
Total, other adverse events	Linezolid	163	970
Total, serious adverse events	Linezolid	50	970

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons8

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Linezolid-without Concomitant Drugs vs Linezolid-with Concomitant Drugs: Factors Considered to Affect the Safety of Linezolid - Concomitant Drugs.	Trial comparisons
Linezolid Without Renal Dysfunctions vs Linezolid- With Renal Dysfunctions: Factors Considered to Affect the Safety of Linezolid - Renal Dysfunctions.	Trial comparisons
Linezolid -Over 40kg vs Linezolid -Less Than 40kg: Factors Considered to Affect the Safety of Linezolid - Weight.	Trial comparisons
Linezolid-without Hepatic Dysfunctions vs Linezolid- With Hepatic Dysfunctions: Factors Considered to Affect the Safety of Linezolid - Hepatic Dysfunctions.	Trial comparisons
Linezolid-administrated Over 15 Days vs Linezolid-administrated Less Than 15 Days: Factors Considered to Affect the Safety of Linezolid - Duration of Drug Administration.	Trial comparisons
Linezolid-without Non-drug Therapies vs Linezolid-with Non-drug Therapies: Factors Considered to Affect the Safety of Linezolid - Non-drug Therapies.	Trial comparisons
Linezolid-male vs Linezolid-female: Factors Considered to Affect the Safety of Linezolid - Gender.	Trial comparisons
Linezolid-over 65 vs Linezolid-less Than 65: Factors Considered to Affect the Safety of Linezolid - Age	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00666276

GET https://conductscience.org/api/trials/v1/NCT00666276/results?page=2

API reference For AI assistants