Intra-Abdominal Infections, Skin Disease, Infectious
Conditions
Keywords
Tygacil, Tigecycline, Post marketing surveillance, Japanese, Infection
Brief summary
Secondary Data Collection Study; safety and effectiveness of Tigecycline .under Japanese medical practice
Interventions
Tigecycline 50 mg intravenously. Therapy conducted according to Japanese LPD of Tygacil. Tygacil will be dosed according to labeling. The administration and duration of the therapy will be determined by the treating physician to meet the patient individual needs for treatment.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All patients who are prescribed tigecycline (Tygacil).
Exclusion criteria
* Subject who have not been prescribed tigecycline (Tygacil).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Drug Reaction (ADR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response Rate | Within 14 days from the start date | Clinical response rate, which was defined as the percentage of participants who achieved clinical response as effective over the total number of assessable effectiveness analysis population(effective plus ineffective,) was presented along with two-sided 95% CI. Clinical response of Tygacil was assessed as effective, ineffective, or indeterminate by the physician at the end of observation period. Overall response of Tygacil was determined by the physician based on laboratory and clinical findings without bacteriological findings. |
| Clinical Response Rate of Cure | Within 28 days post-treatment | The cure rate, which was defined as the percentage of participants who were assessed as cure over the total number of assessable effectiveness analysis population (cure plus failure), was presented along with two-sided 95% CI. Clinical response of cure was assessed as cure, failure, or indeterminate by the physician within 28 days post-treatment. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tygacil (Tigecycline) Participants who received Tygacil as indicated in the approved local product document were observed for a period of 14 days at maximum. The follow-up period was 28 days post-treatment. The dosage can be adjusted as per physician's discretion. | 116 |
| Total | 116 |
Baseline characteristics
| Characteristic | Tygacil (Tigecycline) | — |
|---|---|---|
| Age, Customized ≥15 and <65 years | 47 Participants | — |
| Age, Customized <15 years | 5 Participants | — |
| Age, Customized ≥65 years | 64 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex/Gender, Customized Female | 52 Participants | — |
| Sex/Gender, Customized Male | 64 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 42 / 116 |
| other Total, other adverse events | 54 / 116 |
| serious Total, serious adverse events | 49 / 116 |
Outcome results
Primary
Number of Participants With Adverse Drug Reaction (ADR)
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.
Time frame: Up until 14 days from the start date and 28 days from the end of the observation period
Population: The safety analysis set comprised of participants who had received Tygacil at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tygacil (Tigecycline) | Number of Participants With Adverse Drug Reaction (ADR) | ADR | 41 Participants |
| Tygacil (Tigecycline) | Number of Participants With Adverse Drug Reaction (ADR) | Serious ADR | 15 Participants |
Secondary
Clinical Response Rate
Clinical response rate, which was defined as the percentage of participants who achieved clinical response as effective over the total number of assessable effectiveness analysis population(effective plus ineffective,) was presented along with two-sided 95% CI. Clinical response of Tygacil was assessed as effective, ineffective, or indeterminate by the physician at the end of observation period. Overall response of Tygacil was determined by the physician based on laboratory and clinical findings without bacteriological findings.
Time frame: Within 14 days from the start date
Population: The analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at the end date of the observation period at least once. Participants evaluated as indeterminate (n=28) were excluded from the calculation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tygacil (Tigecycline) | Clinical Response Rate | 73.9 Percentage of Participants |
Secondary
Clinical Response Rate of Cure
The cure rate, which was defined as the percentage of participants who were assessed as cure over the total number of assessable effectiveness analysis population (cure plus failure), was presented along with two-sided 95% CI. Clinical response of cure was assessed as cure, failure, or indeterminate by the physician within 28 days post-treatment.
Time frame: Within 28 days post-treatment
Population: The analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at the Test-of-Cure visit at least once. Participants evaluated as indeterminate (n=38) were excluded from the calculation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tygacil (Tigecycline) | Clinical Response Rate of Cure | 59.0 Percentage of Participants |