Complicated Skin and Skin Structure Infections, Complicated Intra-abdominal Infections
Conditions
Keywords
Observational study, Tigecycline, infection, skin, abdominal
Brief summary
The purpose of this study is to collect post-marketing information on the safety of Tygacil in Filipino patients.
Detailed description
Three-thousand or 10% of total number of patients given tigecycline will be included in the study
Interventions
This is a non-interventional study; patients are administered Tygacil as prescribed by their doctor as per registered indications stated in product label/insert (50 mg by Intravenous Injection).
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Spontaneous Adverse Events | 30 days post injection up to 3 years | Adverse events were based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participant. In addition to the information obtained from these sources, the participant was asked the following nonspecific question: How have you been feeling since your last visit? |
Countries
Philippines
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tygacil 50 mg Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert | 621 |
| Total | 621 |
Baseline characteristics
| Characteristic | Tygacil 50 mg |
|---|---|
| Age Continuous | 55.7 Years STANDARD_DEVIATION 17.4 |
| Sex: Female, Male Female | 254 Participants |
| Sex: Female, Male Male | 367 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 621 |
| serious Total, serious adverse events | 5 / 621 |
Outcome results
Primary
Number of Participants With Spontaneous Adverse Events
Adverse events were based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participant. In addition to the information obtained from these sources, the participant was asked the following nonspecific question: How have you been feeling since your last visit?
Time frame: 30 days post injection up to 3 years
Population: Safety Population: All participants who received at least 1 dose of tygacil
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tygacil 50 mg | Number of Participants With Spontaneous Adverse Events | 17 Participants |