Trial Outcomes & Findings for Retrospective Transverse Observational Study Of Previous Study (Initial Protocol, B1811030) (NCT NCT01840319)
NCT ID: NCT01840319
Last Updated: 2014-07-28
Results Overview
Survival analysis was calculated using Kaplan-Meier Method. The survival status of participants from the initial study database were collected for survival analysis, if participants did not have the data in the database, the participating clinician requested the vital status information from the center for epidemiology and population health research (CESP). The deceased participants' data were collected and the informed consent form was sent to surviving participants. The existing and the collected survival data were then merged and updated. A survival analysis was performed including a variable treatment period plus 30 follow-up days. The maximum treatment duration observed in the initial study was 78 days. Percentage of participants who were alive at 30 days after last dose (corresponding to Day 108 after first dose of tigecycline) of tigecycline were reported.
COMPLETED
156 participants
30 days after last dose of Tigecycline (Day 108)
2014-07-28
Participant Flow
Participants who completed the initial study 3074A1-4448 (B1811030) (NCT00799591) and whose death were not reported at the end of initial study were eligible to participate in the study.
Out of 156 participants who were enrolled in initial study 3074A1-4448 (B1811030) (NCT00799591), 138 participants did not have dates of death, hence, survival data was retrospectively collected for these participants in this study. All data were then combined with the existing survival data for an updated survival analysis.
Participant milestones
| Measure |
Tigecycline
Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
|
|---|---|
|
Overall Study
STARTED
|
156
|
|
Overall Study
COMPLETED
|
156
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Retrospective Transverse Observational Study Of Previous Study (Initial Protocol, B1811030)
Baseline characteristics by cohort
| Measure |
Tigecycline
n=156 Participants
Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
|
|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days after last dose of Tigecycline (Day 108)Population: Intent-to-treat (ITT) population included all participants of the initial study 3074A1-4448 (B1811030) (NCT00799591).
Survival analysis was calculated using Kaplan-Meier Method. The survival status of participants from the initial study database were collected for survival analysis, if participants did not have the data in the database, the participating clinician requested the vital status information from the center for epidemiology and population health research (CESP). The deceased participants' data were collected and the informed consent form was sent to surviving participants. The existing and the collected survival data were then merged and updated. A survival analysis was performed including a variable treatment period plus 30 follow-up days. The maximum treatment duration observed in the initial study was 78 days. Percentage of participants who were alive at 30 days after last dose (corresponding to Day 108 after first dose of tigecycline) of tigecycline were reported.
Outcome measures
| Measure |
Tigecycline
n=156 Participants
Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
|
|---|---|
|
Percentage of Participants With Survival at 30 Days After Last Dose of Tigecycline
|
80.60 percentage of participants
Interval 73.04 to 86.24
|
Adverse Events
Tigecycline
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER