Tygacil Drug Use Investigation (Tigecycline Evaluation Study For Safety And Effectiveness In Patient Infected With Multi-Drug Resistance.)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 116
- Primary Endpoint
- Number of Participants With Adverse Drug Reaction (ADR)
Study Overview
Brief Summary
Secondary Data Collection Study; safety and effectiveness of Tigecycline .under Japanese medical practice
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients who are prescribed tigecycline (Tygacil).
Exclusion Criteria
- •Subject who have not been prescribed tigecycline (Tygacil).
Arms & Interventions
Tigecycline (Tygacil)
Subjects who are treated with tigecycline
Intervention: Tigecycline (Tygacil) (Drug)
Outcomes
Primary Outcomes
Number of Participants With Adverse Drug Reaction (ADR)
Time Frame: Up until 14 days from the start date and 28 days from the end of the observation period
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Tygacil in a participant who received Tygacil. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Tygacil was assessed by the physician.
Secondary Outcomes
- Clinical Response Rate(Within 14 days from the start date)
- Clinical Response Rate of Cure(Within 28 days post-treatment)