This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection (NCT01721408), a randomized phase 4 study. The primary outcome is Clinical Response at the Test-of-Cure (TOC) Assessment Within the Clinically Evaluable (CE) Population.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01721408 |
| Phase | Phase 4 |
| Condition | Intra-abdominal Infection |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 470 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Hospitalized participants with complicated intra-abdominal infection. The primary endpoint was assessed in the clinically evaluable population, defined as clinical modified intent-to-treat participants who met clinical evaluability criteria and had no major protocol violations.
Intervention
Tigecycline, listed in the safety results as tigecycline 50mg.
Comparator
Imipenem/cilastatin.
Primary question
What proportion of clinically evaluable participants had a clinical response at the test-of-cure assessment, and how did the response compare between the randomized treatment groups? The registry record does not report the group-specific primary endpoint results or a comparison estimate.
The study was designed as a comparative evaluation of the efficacy and safety of the two drugs in hospitalized participants with complicated intra-abdominal infection. Its primary measure was clinical response at test of cure, rather than a direct measure of symptoms at a single early visit. The response category was determined by the investigator and could be cure, failure, or indeterminate, according to criteria described in the endpoint definition.
The target question is therefore about the proportion classified as responding in a particular analysis population and at a specified follow-up assessment. It is not simply a question about all randomized participants, because the primary endpoint population excluded participants who did not meet clinical evaluability criteria or had major protocol violations. The record does not report how many participants entered that population in either group.
The stated enrollment was 470. That figure describes enrollment, not the number included in the primary endpoint analysis. No conclusion about the relative clinical-response proportions can be drawn from enrollment alone. The results needed to answer the primary question—group-specific response estimates and their uncertainty—are not reported in the registry record.
3. Trial Design
This was a randomized, parallel-group Phase 4 study of tigecycline compared with imipenem/cilastatin for complicated intra-abdominal infection in hospitalized participants. The registry record describes triple masking. It lists Pfizer as the sponsor and records the study as completed. Enrollment was 470.
The study is described as multicenter, double-blind, and randomized in its official title, while the registry masking classification is triple. These are the descriptions recorded for the study; the registry record does not explain how the masking labels relate to one another or identify the roles of the masked parties. The allocation was randomized, and the model was parallel, meaning the two treatment groups were studied as separate arms rather than as a crossover sequence.
The interventions were tigecycline and imipenem/cilastatin. The arm descriptions contain no additional treatment details. Dosing schedules, routes of administration, and any treatment procedures beyond the intervention names are not reported in the registry record. The primary endpoint timeframe refers to Day 3, Day 14 or the last day of therapy, and test of cure 14-21 days after the last dose. Treatment duration was at least 5 days and up to 14 days.
The study start is recorded as 2012-11, and primary completion as 2015-10. These dates provide context for the trial record but do not describe when each participant was enrolled or assessed. Although the registry records a planned enrollment and completed status, it does not report the rationale for the planned sample size, the allocation ratio, or the operational details of randomization. Those aspects of the design cannot be reconstructed from the registry entry.
The primary endpoint was clinical response at test of cure in the clinically evaluable population. Secondary outcomes included clinical response and microbiological response in the microbiologically evaluable population at test of cure. The registry lists 5 outcome measures and 4 analyses, but does not provide enough detail to establish the complete analysis plan or the relationship between every listed analysis and endpoint.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Of the total of 470 participants randomized, 235 were randomized to each treatment group. Seven participants (4 in tigecycline group and 3 in imipenem/cilastatin group) did not receive study treatment. One participant was randomized to imipenem/cilastatin group but received tigecycline and was reported and analyzed under the tigecycline group.
Overall Study
| Stage | Tigecycline 50mg | Imipenem/Cilastatin |
|---|---|---|
| STARTED | 232 | 231 |
| COMPLETED | 196 | 207 |
| NOT COMPLETED | 36 | 24 |
Reasons for not completing this period:
| Reason | Tigecycline 50mg | Imipenem/Cilastatin |
|---|---|---|
| Adverse Event | 6 | 1 |
| Death | 1 | 0 |
| Insufficient clinical response | 15 | 6 |
| No longer willing to participate study | 9 | 10 |
| Protocol Violation | 0 | 2 |
| Other | 3 | 3 |
| Lost to Follow-up | 1 | 2 |
| Does not meet entrance criteria | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: The CE population was defined as all clinical modified intent-to-treat (c-mITT) participants who satisfied clinical evaluability criteria and had no major protocol violations.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Tigecycline 50mg | Imipenem/Cilastatin | Total |
|---|---|---|---|---|
| Participants analysed | 232 | 231 | 463 | |
| Age, Continuous | years | 48.4 (SD 18.1) | 48.2 (SD 17.6) | 48.3 (SD 17.8) |
| Sex: Female, Male: Female | Participants | 83 | 81 | 164 |
| Sex: Female, Male: Male | Participants | 149 | 150 | 299 |
6. Primary Endpoint
The registry lists the primary outcome as Clinical Response at the Test-of-Cure (TOC) Assessment Within the Clinically Evaluable (CE) Population, measured over Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint was the percentage of participants with a clinical response at the test-of-cure assessment in the clinically evaluable population. Clinical response was determined by the investigator and classified as cure, failure, or indeterminate. Cure required relevant baseline clinical signs and symptoms to disappear or return to normal, relevant non-microbiological laboratory results to return to normal, or resolution sufficient that no further therapy was required. Failure included additional surgical or radiologic intervention, additional anti-infection therapy to cure the infection, certain deaths or treatment-related events, or receipt of greater than 120% of the prescribed number of study-drug doses. Indeterminate status included specified losses to follow-up or deaths that prevented an interpretable test-of-cure assessment.
Test of cure is used to assess response after the treatment period, rather than only during therapy. The registry describes assessments at Day 3, Day 14 or the last day of therapy, and test of cure 14-21 days after the last dose. That timing makes the endpoint a follow-up assessment of whether the clinical criteria were met after treatment. This is a general description of the role of a post-treatment outcome; it does not establish that any particular response occurred in this study.
The clinically evaluable population was a subset of the clinical modified intent-to-treat population: participants had to satisfy clinical evaluability criteria and have no major protocol violations. Such eligibility rules define who contributes to the primary analysis and can affect how its estimate is interpreted. The numbers analyzed and the response proportions are not reported in the registry record, so neither the observed response rate nor the precision of a group comparison can be described.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison and a primary endpoint, but does not report the result needed to interpret that endpoint. There are no group-specific clinical-response percentages, participant counts for the primary analysis, confidence intervals, or test results in the record. The primary comparison therefore cannot be characterized as favoring either group, and its statistical precision cannot be assessed from the available registry information.
The endpoint is a categorical clinical assessment in the clinically evaluable population. Its definition distinguishes cure from failure and indeterminate status. Because the registry entry does not provide counts in these categories or say how the categories were represented in the primary analysis, it is not possible to infer how many participants were classified as responding. The record explicitly indicates that the primary outcome was not reduced to one comparison because it has several categories or time points. That is a reason not to treat the endpoint metadata as if it were a single numerical result.
The total enrollment of 470 does not substitute for the primary-analysis denominator. The primary population was restricted by clinical evaluability and protocol-violation criteria, and the number meeting those criteria is not reported in the registry record. Similarly, safety populations have their own denominators and should not be assumed to match the clinical efficacy population. The safety entries list 232 participants at risk in each group for serious and other adverse-event counts, but those denominators do not establish the number analyzed for the primary endpoint.
The study records clinical response and microbiological response outcomes in the microbiologically evaluable population as secondary measures. The endpoint names indicate that both types of response were considered, but the outcome values are not reported in the registry record. Without those results, the secondary outcomes do not fill the gap in the primary clinical comparison.
Statistical significance and practical importance are different questions. A confidence interval, if reported, would describe the range of effect sizes compatible with the data under the method used; its width would help convey precision. A p-value, if reported, would summarize how compatible the data are with a specified null model, not the probability that a treatment is effective. Neither type of inferential result is available for the primary endpoint in this registry record. General interpretation principles cannot replace the missing trial-specific estimates.
The safety entries report serious adverse-event counts of 32 for tigecycline and 16 for imipenem/cilastatin, with 232 participants at risk in each group. The entries for other adverse events are 57 and 34, respectively, with the same stated at-risk counts. These are descriptive counts in the registry record. They do not establish whether the differences between groups are statistically reliable, and the record does not provide uncertainty estimates or a detailed event-level analysis alongside these figures. Death counts are not reported in the registry record.
Accordingly, the firm statistical reading is limited: the registry describes the design, endpoints, analysis populations, and selected safety counts, but not the primary efficacy estimates. The design supplies context for how a comparison was intended to be made; it does not, by itself, reveal the comparison's result.
9. Statistical Methods Explained
What is the primary outcome scale?
The primary measure is expressed as a percentage of participants with an event, where the event is a clinical response classification at test of cure. A percentage is a way of expressing a count relative to an analysis population. For a binary summary, each participant is assigned to one of two states, such as response or no response. In this study, however, the registry definition includes cure, failure, and indeterminate categories, and the record says the primary outcome has several categories or time points and was not reduced to one comparison. The exact method for turning those categories into a reported primary estimate is not reported in the registry record.
For two randomized groups, a simple unadjusted comparison of response proportions can be expressed as a difference in proportions. That kind of measure asks how far apart the observed group proportions are, while a ratio-based measure describes their relative scale. These are general statistical approaches, not claims about the analysis used in this study. The registry record does not specify a primary effect measure or provide the inputs needed to describe one.
What does a confidence interval communicate?
A confidence interval communicates uncertainty around an estimate under a particular statistical method. A narrower interval indicates greater precision under that method; a wider interval indicates less precision. An interval that includes the value corresponding to no difference would generally be compatible with a range of effects that includes no difference, but the full interpretation depends on the effect measure and analysis. The registry identifies a 95% confidence interval as the dispersion measure for the primary outcome, but does not report the interval bounds or the point estimates. Therefore, the endpoint's precision cannot be judged.
Confidence intervals do not show the probability that the true effect lies in a particular interval after observing the data. They are constructed using a procedure with a long-run coverage interpretation under its assumptions. This is a general explanation, not a description of the calculation performed for this trial, because the exact method is not reported in the registry record.
What is the role of the analysis population?
The primary population is the clinically evaluable population. It comprises clinical modified intent-to-treat participants who satisfied clinical evaluability criteria and had no major protocol violations. Restricting an analysis to participants meeting such criteria can make the endpoint assessment more focused on participants with evaluable clinical information, but it can also mean that the estimate does not directly describe every randomized participant. This is a general consideration of analysis populations. The record does not report the counts excluded, the reasons for exclusion, or the final group denominators for this primary analysis.
Randomization is intended to support a fair comparison of treatment groups by balancing prognostic factors on average, but the protections of randomization apply most directly to analyses that preserve the randomized groups. A clinically evaluable analysis excludes participants according to post-randomization criteria, so its interpretation can differ from an analysis of all randomized participants. This general concern does not show that bias occurred in this trial. The registry record does not report a full analysis plan or enough details to assess the effects of exclusions.
Why can several categories or time points complicate a result?
A response can be reported across different categories, and assessment can occur at multiple time points. Each choice may answer a different question. For example, a response measured during therapy is not identical to a response assessed after treatment. If multiple categories or time points are considered, the analysis must specify which comparison is primary and how the others are interpreted. Without that specification, readers can mistake a selected result for the complete evidence or treat several related results as independent confirmations. The registry notes that the primary outcome was not reduced to one comparison because it has several categories or time points. The specific statistical handling of this structure is not reported in the registry record.
Multiplicity is the general issue that arises when several statistical hypotheses are tested or several outcomes are examined. Without an appropriate plan, the chance of at least one apparently notable result can increase as the number of tests grows. Methods such as prioritizing a primary hypothesis or adjusting inference may be used in some studies, but neither the use nor the details of such methods are reported in the registry record. No particular adjustment should be assumed.
How should safety counts be understood?
Adverse-event counts are descriptive summaries of events or affected participants, depending on how the registry field is defined. The safety entries give numbers at risk and numbers affected for serious and other adverse events. A count alone does not express uncertainty or account for differences in duration of observation. The registry record does not provide a time-to-event analysis or a detailed explanation of whether participants with multiple events are counted once or more than once in these summaries. Consequently, the counts should not be treated as a complete safety comparison.
The record also lists serious-event terms with percentages. Those terms provide selected event descriptions, but the registry entry does not specify an arm-specific denominator for each percentage in that list. The percentages should therefore be read as recorded, without assigning them to a particular treatment group or deriving further comparisons.
What can planning calculations tell a reader?
Sample-size planning is a design exercise based on assumptions about the effect to detect, the significance level, allocation, and statistical method. The stated illustration assumptions use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation, with the effect set as a stated fraction of the observed effect. These are planning assumptions, not results from the randomized comparison. The registry record does not report the trial's own sample-size justification, so the illustration assumptions should not be presented as the original design rationale.
Planning numbers are not observed power. Once a study is complete, its interpretation should focus on the estimated effect and its uncertainty rather than a retrospective probability of detecting an effect. No calculated sample-size illustrations or observed primary effect estimates are reported in the registry record. A design illustration cannot supply the missing endpoint result, and it cannot establish that the study was adequately powered for its actual analysis.
In short, general statistical methods explain what endpoint estimates, intervals, populations, and multiplicity procedures would mean, but the registry record does not report enough numerical results or analytic detail to attribute a specific inferential method to this trial. The trial-specific result remains unquantified in the record.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome is described across several categories or time points, and the registry record states that it was not reduced to one comparison. It also lists secondary clinical-response and microbiological-response outcomes in the microbiologically evaluable population. Considering multiple outcomes or assessments raises a general multiplicity question: the analysis should make clear which result is primary and how secondary or repeated assessments are handled. The registry record does not report a multiplicity adjustment, a hierarchy among the outcomes, or a complete statistical analysis plan. It is not possible to say whether any adjustment was used.
The primary population is clinically evaluable, defined as clinical modified intent-to-treat participants meeting clinical evaluability criteria and having no major protocol violations. The registry record does not report the numbers excluded from this population, the reasons for exclusion, or the group-specific analysis denominators. It also does not report how missing endpoint assessments were handled, whether indeterminate responses were included in a particular category, or whether any sensitivity analyses were conducted. These details matter because exclusions and unavailable outcomes can affect the interpretation of a response proportion.
The record lists 5 outcome measures and 4 analyses, but those totals do not describe the analysis methods or resolve the missing-data questions. A number of measures is not a substitute for knowing the prespecified hierarchy, the population used for each estimate, and the rules applied to incomplete observations. The relevant handling of multiplicity and missing data is not reported in the registry record.
As a result, neither the risk of selective emphasis among multiple results nor the sensitivity of the primary estimate to missing observations can be assessed from the registry entry. This is an uncertainty about reporting and analysis detail, not evidence that a particular analytic problem occurred.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Tigecycline 50mg | 32 | 232 | 13.8% |
| Imipenem/Cilastatin | 16 | 232 | 6.9% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Tigecycline 50mg | 57 of 232 |
| Imipenem/Cilastatin | 34 of 232 |
Most frequent serious adverse event terms
| Event term | Organ system | Tigecycline 50mg | Imipenem/Cilastatin |
|---|---|---|---|
| Drug ineffective | General disorders | 21 of 232 | 9 of 232 |
| Postoperative wound infection | Infections and infestations | 7 of 232 | 2 of 232 |
| Lung infection | Infections and infestations | 3 of 232 | 0 of 232 |
| Atrial fibrillation | Cardiac disorders | 1 of 232 | 0 of 232 |
| Abdominal pain | Gastrointestinal disorders | 0 of 232 | 1 of 232 |
| Pancreatitis acute | Gastrointestinal disorders | 1 of 232 | 0 of 232 |
| Sudden death | General disorders | 1 of 232 | 0 of 232 |
| Bile duct stone | Hepatobiliary disorders | 0 of 232 | 1 of 232 |
| Cholecystitis acute | Hepatobiliary disorders | 1 of 232 | 0 of 232 |
| Hepatic failure | Hepatobiliary disorders | 1 of 232 | 0 of 232 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Tigecycline 50mg | Imipenem/Cilastatin |
|---|---|---|---|
| Pyrexia | General disorders | 18 of 232 | 20 of 232 |
| Nausea | Gastrointestinal disorders | 24 of 232 | 10 of 232 |
| Vomiting | Gastrointestinal disorders | 19 of 232 | 10 of 232 |
| Postoperative wound infection | Infections and infestations | 14 of 232 | 1 of 232 |
Serious events with the highest arm-level rate: drug ineffective (9.1%), postoperative wound infection (3.0%), lung infection (1.3%), atrial fibrillation (0.4%), abdominal pain (0.4%).
The registry safety entries list 232 participants at risk in each group. Serious adverse events affected 32 participants in the tigecycline 50mg group and 16 in the imipenem/cilastatin group. Other adverse events affected 57 and 34 participants, respectively. These counts are descriptive; without uncertainty estimates or an analysis method, they do not establish the size or reliability of a between-group difference.
The record also lists serious-event terms with percentages: Drug ineffective, 9.1%; Postoperative wound infection, 3.0%; Lung infection, 1.3%; Atrial fibrillation, 0.4%; Abdominal pain, 0.4%; and Pancreatitis acute, 0.4%. The registry record does not identify an arm-specific denominator for these term percentages, so they should not be attributed to either group. They are selected terms, not a complete account of all safety outcomes.
Death counts are not reported in the registry record. The adverse-event counts do not indicate event timing, duration, severity beyond the serious classification, or whether an individual could contribute more than one event. They should therefore be read as recorded counts, not as a complete evaluation of comparative safety.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, triple-masked, parallel-group Phase 4 study compared tigecycline with imipenem/cilastatin in hospitalized participants with complicated intra-abdominal infection. It identifies clinical response at test of cure in a clinically evaluable population as the primary endpoint and describes how cure, failure, and indeterminate response were classified. It also gives selected safety counts and names secondary clinical and microbiological outcomes.
Those design and endpoint details explain what the study set out to assess. They do not reveal the observed clinical-response proportions. The arm-level primary results, confidence intervals, and comparison statistics are not reported in the registry record. It is therefore not possible to say from this record whether response estimates differed, how large any difference was, or how precisely it was estimated. No treatment-effect conclusion should be inferred from the study title, completion status, enrollment, or safety counts.
The safety information likewise has a limited interpretation. Counts of participants affected are reported for serious and other adverse events, but no comparative uncertainty analysis is included in the record. The event-term percentages are not assigned to treatment groups in the available entry, and death counts are not reported. These registry entries do not support a complete comparison of the safety profiles.
The registry entry also does not report the trial's own sample-size justification, full statistical analysis plan, handling of missing outcomes, or approach to multiplicity. These omissions limit assessment of how the analysis was planned and how robust any hypothetical estimate would be to analytic choices. General statistical principles can explain why those details matter, but cannot fill in trial-specific results or decisions.
The appropriate conclusion is narrow: the registry documents the study design, endpoint definitions, and selected safety figures, while leaving the primary comparative efficacy result unavailable. This is a statement about what the registry record reports, not a conclusion about the treatments beyond those posted data.
13. Why This Trial Matters Statistically
This trial is statistically notable because its primary endpoint is not a single uncomplicated count in the registry record. Clinical response has cure, failure, and indeterminate categories, with assessments over the treatment course and at test of cure. The registry explicitly indicates that the endpoint was not reduced to one comparison. This makes it important to distinguish endpoint definition from endpoint result: the classification rules are described, but the group-specific estimates needed for a comparison are not.
The analysis population also shapes the question. The primary endpoint uses the clinically evaluable population rather than all enrolled participants. That population is defined using clinical evaluability criteria and the absence of major protocol violations. A reader therefore needs the number analyzed and the rules for missing or indeterminate assessments to understand the estimate's scope. Those details and the outcome counts are not reported in the registry record.
The case also illustrates why enrollment and statistical evidence are not interchangeable. Enrollment was 470, but the number contributing to the primary analysis and the precision of the comparison cannot be inferred from that total. Likewise, a completed randomized study does not by itself reveal whether an observed difference was large, small, or uncertain. Those judgments require reported estimates and an analysis description.
Finally, the registry provides selected safety counts but not a complete inferential comparison. Descriptive counts can alert readers to what was recorded, yet they do not show uncertainty or resolve how event terms and denominators were defined. Taken together, the entry is useful for understanding the design and measurement framework, while demonstrating the limits of interpreting a trial when its primary numerical results and analysis details are absent.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main trial-specific limitation for statistical interpretation is that the registry record does not report the primary endpoint results. It gives the clinical-response definition, the analysis population, and the assessment timeframe, but not the response counts, percentages, confidence interval bounds, or group comparison. Consequently, the primary effect and its precision cannot be evaluated.
The primary outcome is described as having several categories or time points and is not reduced to one comparison. The record does not explain how the categories were combined or analyzed, which assessment was used for each primary estimate, or how indeterminate outcomes entered the analysis. The primary population is defined, but its group-specific sizes and the reasons participants may have failed to meet clinical evaluability criteria are not reported.
The entry names secondary outcomes in the microbiologically evaluable population but does not report their results or the sizes of those analysis populations. It lists 5 outcome measures and 4 analyses, without giving a complete analysis plan. The approach to multiplicity, missing data, and sensitivity analysis is not reported in the registry record. The trial's own sample-size justification is also not reported.
Safety information is limited to selected counts and event terms. The record does not report death counts, uncertainty estimates for adverse-event comparisons, event timing, or enough detail to determine how repeated events were handled. The serious-event term percentages are not assigned to a treatment group in the record.
These limitations describe gaps in the registry information. They do not establish that the trial itself lacked an analysis plan or that any particular bias occurred; those matters are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection — NCT01721408.
- Registry record last updated 2018-04-09; status last verified 2017-09.
- Results first posted 2018-04-09.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT01721408 is a completed randomized, triple-masked, parallel-group Phase 4 study comparing tigecycline with imipenem/cilastatin for complicated intra-abdominal infection in hospitalized participants. Enrollment was 470. The primary endpoint was clinical response at test of cure in the clinically evaluable population, with cure, failure, and indeterminate classifications.
The registry describes assessments during treatment and at test of cure 14-21 days after the last dose. Secondary outcomes include clinical and microbiological response in the microbiologically evaluable population. The safety entries list 232 participants at risk in each group, with serious adverse events affecting 32 participants in the tigecycline 50mg group and 16 in the imipenem/cilastatin group.
Primary response estimates, confidence intervals, the full analysis plan, and the trial's sample-size justification are not reported in the registry record. The available entry therefore documents the design and selected safety information but does not provide a numerical primary efficacy comparison.