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 Paclitaxel and Carboplatin in Treating Patients With Persistent or Recurrent Stage III or Stage IV Uterine Cancer (NCT00112489), a na phase 2 study. The primary outcome is Nature and Degree of Toxicity.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00112489 |
| Phase | Phase 2 |
| Condition | Sarcoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 55 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Gynecologic Oncology Group |
| Results posted | Yes |
2. Clinical Question
Population
The official title describes people with advanced, persistent, or recurrent uterine carcinosarcoma. The brief summary describes patients with persistent or recurrent stage III or stage IV uterine cancer. The primary outcome population is identified as eligible and evaluable patients. The registry record does not give further eligibility details or explain how the population in the summary relates to the official title.
Intervention
The study evaluated paclitaxel followed by carboplatin. The regimen is described as paclitaxel 175 mg/m2 intravenously over 3 hours, followed by carboplatin AUC = 6 intravenously over 30 minutes, every 21 days until disease progression or adverse effects prohibit further therapy.
Comparator
There was no comparison arm in the registry design: the model is single group, allocation is listed as not applicable, and masking is none. The registry record therefore does not provide a concurrent control group for comparing the regimen with another treatment or with no treatment.
Primary question
The primary outcome is titled Nature and Degree of Toxicity. It counts eligible and evaluable participants who experienced a grade 1 or higher serious adverse event, regardless of attribution, using CTCAE v3.0. The stated observation period is during study treatment and up to 30 days after stopping study treatment. The registry record does not report a comparative efficacy question or a statistical analysis of this toxicity outcome.
3. Trial Design
The registry identifies this as a phase II study sponsored by the Gynecologic Oncology Group. It is listed as completed, with enrollment of 55. The start is recorded as 2005-05 and primary completion as 2010-07. These dates and the enrollment describe the registry record; they do not establish how many participants contributed to each outcome.
The design is single group, with allocation listed as not applicable and masking listed as none. Participants received paclitaxel followed by carboplatin according to the stated regimen: paclitaxel 175 mg/m2 intravenously over 3 hours, then carboplatin AUC = 6 intravenously over 30 minutes every 21 days, until disease progression or adverse effects prohibited further therapy. The registry record does not describe a randomized assignment or a blinded comparison.
The primary outcome population is eligible and evaluable patients, while the posted adverse-event group lists 46 participants at risk. The overall enrollment of 55 and this outcome denominator refer to different reported quantities; the registry record does not explain participant flow between them. The record lists 2 outcome measures and 0 analyses. It does not report the protocol’s sample-size justification, planned statistical analysis, interim analyses, or the handling of participants who were not evaluable. Those omissions prevent a full account of how the completed study was intended to answer its research questions.
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.
Overall Study
| Stage | Paclitaxel Followed by Carboplatin |
|---|---|
| STARTED | 55 |
| COMPLETED | 15 |
| NOT COMPLETED | 40 |
Reasons for not completing this period:
| Reason | Paclitaxel Followed by Carboplatin |
|---|---|
| Refused further treatment | 8 |
| Adverse Event | 12 |
| Death | 2 |
| Other, Not Specified | 9 |
| Patient never treated | 2 |
| Ineligible | 7 |
Analysis population for the primary outcome, as defined in the registry: Eligible and Evaluable patients
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.
Population: Total eligible and treated participants
| Characteristic | Unit | Paclitaxel Followed by Carboplatin |
|---|---|---|
| Participants analysed | 46 | |
| Age, Customized: Age at Study Entry | years | 65.5 (SD 11.6) |
| Sex: Female, Male: Female | Participants | 46 |
| Sex: Female, Male: Male | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Nature and Degree of Toxicity, measured over During study treatment and up to 30 days after stopping study treatment.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint, Nature and Degree of Toxicity, is a count of participants who experienced a grade 1 or higher serious adverse event. The registry specifies that events are counted regardless of attribution and classified using CTCAE v3.0. The observation period covers study treatment and extends up to 30 days after treatment stops. The outcome population is eligible and evaluable patients.
A participant count gives a direct description of how many people in the reported analysis population experienced an event under the registry’s definition. It is not a measure of how often an event occurred in total, since a person may experience more than one event. Nor does the count by itself establish that treatment caused an event: the registry definition explicitly includes events regardless of attribution.
In general, a toxicity endpoint is used to characterize harms observed during and after treatment. Its interpretation depends on the event definition, observation period, and population included in the analysis. The registry record gives those details for this endpoint, but does not report a statistical analysis, an uncertainty interval, or a comparison with another group. The posted count can therefore describe recorded experience in the study group, but cannot by itself quantify a treatment-attributable risk or establish how toxicity compares with another approach.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports 11 participants with a serious adverse event among 46 at risk in the paclitaxel-followed-by-carboplatin group. This is a count within a single-group study, not a contrast between treatments. The record’s primary outcome definition counts participants with grade 1 or higher serious adverse events regardless of attribution, during study treatment and up to 30 days after stopping treatment. The group-level count should be read in that context rather than as proof that the regimen caused each event.
The record also lists other adverse events for 46 participants at risk and 46 affected. These figures are distinct from the serious-event count. They do not show how many events occurred, how severe each event was, or whether participants experienced more than one event. The registry lists several serious-event terms with percentages: Vomiting, Neutrophils, and Dyspnea are each listed at 4.3%; PTT, Fatigue, and Cardiac ischemia/infarction are each listed at 2.2%. Those term-level entries should not be treated as a complete account of every event unless the registry record establishes that they are exhaustive; it does not do so in the posted information.
The registry reports enrollment of 55, whereas the adverse-event group lists 46 at risk. The record does not explain the difference, so the enrolled population should not be substituted for the denominator in the adverse-event figures. The primary outcome population is described as eligible and evaluable, but the record does not give further details about exclusions, missing observations, or the relationship between that population and the 46 participants at risk.
No analyses are listed in the registry record. It therefore does not report a confidence interval, a hypothesis test, or an adjusted estimate for the primary outcome. In general, a confidence interval describes the uncertainty around an estimate; without one, the precision of the posted count cannot be assessed through an interval estimate. The lack of a control group also means that these figures cannot distinguish treatment-related events from events that might have occurred without this regimen or under a different treatment. The data describe recorded events in the study group; they do not establish a comparative effect or an efficacy result.
9. Statistical Methods Explained
The record describes a single-group phase II study and lists no analyses. Consequently, the registry does not identify an inferential method used to evaluate the primary toxicity outcome. The endpoint is a binary participant-level outcome in the sense that each eligible and evaluable participant either meets the event definition during the stated observation period or does not. The posted primary outcome is expressed as a count of participants, rather than as a model-based estimate.
In general, a count is most informative when read alongside its analysis population and event definition. Here, the primary outcome population is eligible and evaluable patients, and the definition is grade 1 or higher serious adverse event regardless of attribution under CTCAE v3.0. The adverse-event summary separately identifies 46 participants at risk and 11 with a serious adverse event. The record does not say whether every person enrolled was eligible, evaluable, or at risk for every event measure. It also does not explain the pathway from enrollment of 55 to the 46 listed at risk. Those population details matter because counts with different denominators describe different sets of participants.
In general, a proportion can express a count relative to its defined denominator, but the registry’s posted outcome is a count, and no recalculated proportion is needed to interpret the posted figures. A count does not convey whether participants experienced one event or several, and an event-term listing does not necessarily describe the number of affected participants for every term. The record lists term percentages for selected serious events, but does not report all supporting details needed to reconstruct those percentages, such as the calculation method or term-specific counts.
No confidence interval or hypothesis test is reported. In general, a confidence interval communicates the range of values compatible with the observed data under a specified statistical procedure. It helps readers judge how precisely an estimate has been measured. A point count alone does not provide that interval-based assessment. A hypothesis test addresses a specified comparison or null hypothesis; in a single-group study, its interpretation would depend on the chosen reference value or model. The registry record does not report such a reference or test. These general concepts do not imply that the trial used either method.
The design has no concurrent comparator, so conventional between-arm comparisons cannot be made from the posted study data. A single-group result can describe events observed among participants receiving the regimen, but it cannot by itself identify what would have happened to those same participants under an alternative. General causal interpretation requires a defensible comparison and assumptions about how groups differ; this record contains no randomized control group or reported adjustment that could address such a comparison.
The sample-size material is described as a planning illustration computed from an observed effect, not as the study’s own design. Its stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a fraction of the observed effect. The illustration is therefore a hypothetical planning framework, not an account of this single-group trial’s enrollment plan or an observed power calculation. Sample sizes in such illustrations are planning quantities, not evidence that the trial had a particular probability of detecting an effect. The registry record does not report the trial’s own sample-size justification.
In general, statistical models can be used to account for features such as repeated observations, unequal follow-up, or differences in participant characteristics. No model or adjustment is reported for this outcome. The adverse-event observation window is specified, but the record does not describe how event timing, multiple events per participant, or incomplete follow-up were handled in an analysis. Over-dispersion is a concern for some count models when variability exceeds a model’s assumptions; it is not a conclusion that can be drawn from the posted participant counts, and no count-model analysis is reported.
The record lists 2 outcome measures but 0 analyses. The registry does not report a multiplicity procedure, a hierarchy of statistical tests, or an analysis plan identifying which outcomes were intended for formal testing. Without these details, the posted safety figures should be read descriptively, not as evidence of a prespecified statistical finding.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 2 outcome measures and 0 analyses. It identifies Nature and Degree of Toxicity as the primary outcome and gives its definition, population, and observation period. The details of the other outcome measure are not reported in the registry record. No multiplicity adjustment, testing hierarchy, or plan for handling multiple comparisons is reported. Since no analyses are listed, it is not possible to determine whether any statistical tests were performed or whether adjustment was considered.
Missing-data handling is not reported in the registry record. The posted adverse-event group has 46 participants at risk, while enrollment is 55, but the record does not explain the participant flow or why these counts differ. It does not say whether participants left treatment, had incomplete follow-up, or were excluded from an evaluable population. Those possibilities must not be inferred from the counts alone.
The primary endpoint population is described as eligible and evaluable patients. The registry record does not define the evaluability criteria or state how missing outcome information affected inclusion. It also does not report sensitivity analyses for missing observations. As a result, the posted count cannot be assumed to represent all enrolled participants, and the effect of any missing information on the reported safety summary cannot be assessed.
The registry does not report interim analyses, a detailed statistical analysis plan, or a sample-size justification for the trial. These absences limit assessment of whether outcome definitions, analysis populations, and statistical procedures were specified before results were known. The record supports a descriptive reading of the reported figures, but not a reconstruction of the full analysis process.
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 |
|---|---|---|---|
| Paclitaxel Followed by Carboplatin | 11 | 46 | 23.9% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Paclitaxel Followed by Carboplatin | 46 of 46 |
Most frequent serious adverse event terms
| Event term | Organ system | Paclitaxel Followed by Carboplatin |
|---|---|---|
| Vomiting | Gastrointestinal disorders | 2 of 46 |
| Neutrophils | Blood and lymphatic system disorders | 2 of 46 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 2 of 46 |
| PTT | Vascular disorders | 1 of 46 |
| Fatigue | General disorders | 1 of 46 |
| Cardiac ischemia/infarction | Cardiac disorders | 1 of 46 |
| S/n arrhythmia: atrial fibrillation | Cardiac disorders | 1 of 46 |
| Supraventricular tachycardia | Cardiac disorders | 1 of 46 |
| Hypotension | Cardiac disorders | 1 of 46 |
| Death, no ctcae term - death nos | General disorders | 1 of 46 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Paclitaxel Followed by Carboplatin |
|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 43 of 46 |
| Leukopenia | Blood and lymphatic system disorders | 40 of 46 |
| Anemia | Blood and lymphatic system disorders | 32 of 46 |
| Alopecia | Skin and subcutaneous tissue disorders | 31 of 46 |
| Fatigue | General disorders | 24 of 46 |
| Sensory Neuropathy | Nervous system disorders | 18 of 46 |
| Other, Gastrointestinal | Gastrointestinal disorders | 16 of 46 |
| Thrombocytopenia | Blood and lymphatic system disorders | 10 of 46 |
| Nausea | Gastrointestinal disorders | 9 of 46 |
| Pain | General disorders | 8 of 46 |
Serious events with the highest arm-level rate: vomiting (4.3%), neutrophils (4.3%), dyspnea (4.3%), ptt (2.2%), fatigue (2.2%).
The serious adverse-event group lists 46 participants at risk and 11 affected. The primary outcome definition counts participants with grade 1 or higher serious adverse events regardless of attribution, during treatment and up to 30 days after treatment stops. These are participant counts under the registry’s event definition; they do not establish that treatment caused each event.
The registry also lists selected serious-event terms with percentages: Vomiting, Neutrophils, and Dyspnea at 4.3% each; PTT, Fatigue, and Cardiac ischemia/infarction at 2.2% each. These term-level percentages are not interchangeable with the count of participants experiencing any serious adverse event. The record does not give term-specific counts or clarify whether the listed terms cover all serious events. The deaths field has no reported count.
The separate other-adverse-event group lists 46 at risk and 46 affected. That figure indicates affected participants in that grouping, not the number of events or their severity. The registry record does not supply a comparison group, an adjusted safety estimate, or an uncertainty interval. Safety interpretation should therefore stay descriptive and account for the defined observation period and reported population.
12. What the Result Does, and Does Not, Mean
The posted data describe a single group treated with paclitaxel followed by carboplatin and report serious adverse events in 11 participants among 46 listed at risk. They also report 46 participants affected in the separate other-adverse-event grouping. These findings are records of events in the study group, interpreted under the registry’s definitions and observation period.
The figures do not establish whether the regimen caused a particular event. The primary outcome explicitly includes serious adverse events regardless of attribution, and there is no comparison group showing event experience under another treatment or without the study regimen. The counts also do not show the total number of events, because a participant may have experienced more than one. The listed term percentages provide additional descriptive information, but their supporting counts and full scope are not reported.
The findings do not answer a comparative efficacy question. The registry record does not post an efficacy result or a statistical analysis of the primary toxicity endpoint. No confidence interval or hypothesis test is reported, so the precision of an estimated treatment effect cannot be assessed from the record. Enrollment of 55 should not be treated as the denominator for the adverse-event count, which is reported for 46 at risk.
In general, a single-group phase II study can document treatment experience and observed events, but causal or comparative conclusions require evidence that addresses what would have happened under an alternative. The record does not report that kind of comparison. Its figures should be read as descriptive safety information for the participants included in the posted group, with the limits imposed by the undocumented participant flow and analysis methods.
13. Why This Trial Matters Statistically
This trial illustrates why design and endpoint details matter when reading clinical safety statistics. A count of participants with serious adverse events is meaningful only in relation to the event definition, observation period, and analysis population. The registry identifies those features for its primary outcome: grade 1 or higher serious adverse events regardless of attribution, using CTCAE v3.0, during treatment and up to 30 days after stopping treatment, among eligible and evaluable patients.
The record also illustrates the distinction between enrollment and an outcome denominator. It reports enrollment of 55, while the adverse-event group lists 46 participants at risk. Without participant-flow details, readers cannot determine why the counts differ or how the evaluable population was formed. That distinction is important for interpreting any event count accurately.
The single-group design places a further boundary on statistical interpretation. It can describe events in the study group, but it does not offer a concurrent treatment comparison. The registry lists no analyses, confidence intervals, or hypothesis tests, so the posted event counts cannot be treated as a comparative estimate or a formal statistical finding.
Finally, the sample-size material is explicitly a planning illustration based on assumptions involving two arms, whereas the registered trial is single group. Recognizing that difference prevents a hypothetical planning exercise from being mistaken for the trial’s design rationale or observed power. Together, these details show how registry completeness and design shape what can be concluded from posted clinical data.
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 registry record leaves important design and reporting details unresolved. It gives enrollment of 55 and an adverse-event group with 46 participants at risk, but does not describe participant flow or explain the difference. The endpoint population is eligible and evaluable patients, yet the eligibility and evaluability criteria are not reported in the posted information. The relationship between that population and the adverse-event denominator is therefore unclear.
The record lists 2 outcome measures but provides details for the primary toxicity outcome and lists 0 analyses. The other outcome measure’s details, statistical methods, uncertainty estimates, and any hypothesis tests are not reported in the registry record. Missing-data handling, interim analyses, and the trial’s own sample-size justification are also not reported. These omissions limit assessment of precision, analysis choices, and the completeness of outcome reporting.
The serious-event terms are listed with percentages, but term-specific participant counts and the full scope of the term list are not reported. The record also has no reported death count. The separate other-adverse-event figures do not give event counts or severity details beyond the grouping shown.
Because the study is single group, the posted safety information has no concurrent control for distinguishing treatment-related events from background events or comparing event experience with another approach. The registry record describes a regimen and observation period, but the figures alone do not establish causation. These limitations apply to interpretation of the posted record and do not establish what may have been reported elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Paclitaxel and Carboplatin in Treating Patients With Persistent or Recurrent Stage III or Stage IV Uterine Cancer — NCT00112489.
- Registry record last updated 2018-09-25; status last verified 2014-04.
- Results first posted 2014-05-12.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry identifies NCT00112489 as a completed phase II, single-group study sponsored by the Gynecologic Oncology Group. Enrollment is 55; the recorded start is 2005-05 and primary completion is 2010-07. The official title describes evaluation of paclitaxel and carboplatin for advanced, persistent, or recurrent uterine carcinosarcoma. The brief summary refers to persistent or recurrent stage III or stage IV uterine cancer.
The regimen is paclitaxel 175 mg/m2 intravenously over 3 hours followed by carboplatin AUC = 6 intravenously over 30 minutes every 21 days, until disease progression or adverse effects prohibit further therapy. The primary outcome counts eligible and evaluable participants with grade 1 or higher serious adverse events regardless of attribution, during treatment and up to 30 days after treatment stops.
The adverse-event group lists 46 at risk and 11 with a serious adverse event. The registry lists 2 outcome measures and 0 analyses. It does not report a comparative efficacy result, a statistical analysis, or an explanation of the difference between enrollment and the adverse-event denominator.