N/A
N=1,004
Drug Use Investigation Of Zyvox (Linezolid) (Regulatory Post Marketing Commitment Plan)
Staphylococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00666276 ↗Enrolled (actual)
1,004
Serious AEs
5.1%
Results posted
Jul 2012
Primary outcome: Primary: Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. — 1; 1; 1; 1 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- linezolid (Zyvox) (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. |
1; 1; 1; 1; 1; 1 | — |
| PRIMARY Number of Participants With Adverse Drug Reactions(ADRs). |
163 | — |
| PRIMARY Factors Considered to Affect the Safety of Linezolid - Gender. |
109; 54 | =0.712 |
| PRIMARY Factors Considered to Affect the Safety of Linezolid - Age |
122; 41 | =0.257 |
| PRIMARY Factors Considered to Affect the Safety of Linezolid - Hepatic Dysfunctions. |
137; 26 | =0.082 |
| PRIMARY Factors Considered to Affect the Safety of Linezolid - Renal Dysfunctions. |
125; 38 | =0.462 |
| PRIMARY Factors Considered to Affect the Safety of Linezolid - Duration of Drug Administration. |
53; 110 | <0.001 sig |
| PRIMARY Factors Considered to Affect the Safety of Linezolid - Route of Administration. |
29; 116; 18 | =0.018 sig |
| PRIMARY Factors Considered to Affect the Safety of Linezolid - Weight. |
108; 20 | =0.311 |
| PRIMARY Factors Considered to Affect the Safety of Linezolid - Concomitant Drugs. |
9; 154 | =0.044 sig |
| PRIMARY Factors Considered to Affect the Safety of Linezolid - Non-drug Therapies. |
87; 76 | =0.008 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients need to be administered Linezolid in order to be enrolled in the surveillance.
Exclusion Criteria
- Patients not administered Linezolid.
Data sourced from ClinicalTrials.gov (NCT00666276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.