N/A
N=621
Post-Marketing Study Of The Safety Of Tygacil (Tigecycline)
Complicated Skin and Skin Structure Infections · Complicated Intra-abdominal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00683332 ↗Enrolled (actual)
621
Serious AEs
0.8%
Results posted
Jul 2011
Primary outcome: Primary: Number of Participants With Spontaneous Adverse Events — 17 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Tigecycline (Tygacil) (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Spontaneous Adverse Events |
17 | — |
Summary
The purpose of this study is to collect post-marketing information on the safety of Tygacil in Filipino patients.
Eligibility Criteria
Inclusion Criteria
- All patients from the study center who received or will receive at least one dose of Tygacil according to the approved product indication.
Exclusion Criteria
- Previously discontinued Tygacil therapy due to significant safety concern.
Data sourced from ClinicalTrials.gov (NCT00683332). 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.