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 Taxol Carboplatin and Erythropoetin (NCT00158379), a na phase 2 study. The primary outcome is Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25%.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00158379 |
| Phase | Phase 2 |
| Condition | Ovarian Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 105 |
| Arms in the primary outcome | n/a |
| Lead sponsor | North Eastern German Society of Gynaecological Oncology |
| Results posted | Yes |
2. Clinical Question
Population
The official title describes female patients with advanced ovarian cancer, covering FIGO IA/G3 through IV. The condition is listed as ovarian cancer. The registry records enrollment of 105 participants, but it does not report further baseline characteristics or a more detailed outcome population.
Intervention
The official title refers to carboplatin, Taxol® therapy, and additional epoetin alfa. The listed intervention is paclitaxel, and the arm is titled Paclitaxel. The registry does not give an arm description or a detailed treatment schedule, so the title and intervention listing do not establish what was administered to each participant.
Comparator
No comparator arm is listed. The study model is single-group, and allocation is recorded as NA. This is not a randomized comparison, so there is no like-for-like control group in the registry record against which to estimate a treatment contrast.
Primary question
The primary outcome is progression-free survival, expressed as a median in months with a 95% confidence interval. Progression is defined using WHO criteria as the appearance of any new lesion or an increase in existing lesions by at least 25%. The record describes time to progression assessed through physical examination and radiologic imaging. It does not report the median, its confidence interval, or a numerical estimate of treatment effect.
Statistically, the study can describe the recorded outcome experience in its single group, if results are available. It cannot by itself isolate the effect of a treatment from the natural course of disease, other care, or differences between this group and a separate comparison group. The central interpretive question is therefore narrower than whether a regimen is better than another: what does the registry report about time to progression, and how precisely is that result estimated? In this record, the endpoint definition and assessment timeframe are described, but the numerical outcome result is not reported in the registry record.
3. Trial Design
This is a completed phase 2 study with a single-group model. The registry records enrollment of 105 participants and identifies ovarian cancer as the condition. The official title specifies female patients with advanced ovarian cancer, with disease categories described as FIGO IA/G3 through IV. The sponsor is the North Eastern German Society of Gynaecological Oncology.
The registry lists paclitaxel as the intervention and gives the arm the same name, but the arm description is blank. The official title also mentions carboplatin, Taxol® therapy, and additional epoetin alfa. Because the intervention listing and the title do not fully align in their detail, the treatment components and their administration cannot be reconstructed from this record alone. A treatment schedule, dose, duration, and adherence information are not reported in the registry record.
Allocation is listed as NA, masking as none, and the model as single-group. There is no randomized comparator arm listed. Consequently, the registry design does not support a direct randomized comparison of outcomes between treatment groups. The record gives a study start of 2003-07 and a primary completion date of 2008-04; its status is completed.
The primary outcome is progression-free survival, with progression defined by WHO criteria. The stated timeframe is every 3 months for up to 3 years. Toxicity is listed as a secondary outcome. The registry indicates 2 outcome measures and 0 analyses, but does not describe a statistical analysis plan, analysis population, or handling of participants who did not complete follow-up. The design information establishes the broad structure of the study; it does not supply the numerical efficacy result needed to assess the observed outcome or its precision.
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 |
|---|---|
| STARTED | 105 |
| COMPLETED | 105 |
| NOT COMPLETED | 0 |
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 | Paclitaxel |
|---|---|---|
| Participants analysed | 105 | |
| Age, Continuous | years | 60.4 (23.4 to 80.3) |
| Gender: Female | Participants | 105 |
| Gender: Male | Participants | 0 |
| Region of Enrollment: Germany | participants | 105 |
6. Primary Endpoint
The registry lists the primary outcome as Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25%, measured over every 3 months for up to 3 years.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint is progression-free survival, reported as a median in months with a 95% confidence interval. The record defines progression as the appearance of any new lesion or an increase in existing lesions by at least 25%, according to WHO criteria. Its brief summary refers to time to progression assessed through physical examination and radiologic imaging. Assessments are stated to occur every 3 months for up to 3 years.
Time-to-event endpoints are used to describe how long it takes for a defined event to occur. In general, they can use information from participants whose event has not been observed by the end of follow-up, provided the analysis handles that follow-up appropriately. A median time-to-event result marks the point at which the estimated event-free proportion reaches the midpoint under the analysis method. It is not an average, and it does not describe each participant's individual course.
The endpoint is clinically interpretable because it uses a stated definition of progression and a described assessment approach. However, the registry record does not report the median progression-free survival or its confidence interval. It also does not report details such as censoring rules, the analysis population, or how deaths were handled in the endpoint definition. Without the outcome estimate and those analytic details, the endpoint definition alone cannot establish the observed duration or the precision of the result.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record identifies a progression-free survival endpoint and describes how progression was defined, but it does not report the numerical median or its 95% confidence interval. No hazard-ratio value, p-value, or other numerical treatment-effect estimate is reported in the registry record. As a result, the posted information does not permit a quantitative assessment of the outcome's magnitude or precision. A stated endpoint and assessment schedule are not substitutes for the endpoint result.
The single-group design is central to interpretation. An outcome observed in one group can describe that group's experience, but without a comparator it cannot establish what would have happened to a comparable group under a different treatment or under another care strategy. Differences from outcomes reported elsewhere would not be a randomized contrast: patient characteristics, eligibility, follow-up, outcome assessment, and clinical care could differ. This is why the registry record is not a like-for-like control comparison.
The title includes carboplatin, Taxol® therapy, and epoetin alfa, while the intervention listing identifies paclitaxel and the arm description is blank. This means the treatment details should not be expanded beyond what the record states. In particular, the title does not establish the dose, sequence, duration, or actual receipt of each named component. The available record also does not give baseline disease characteristics or treatment adherence information that would help explain variation in outcomes.
The registry reports a timeframe of every 3 months for up to 3 years. In general, repeated assessment can affect the timing at which progression is detected: an event may be identified at an assessment rather than at the exact time it began. The record does not explain how event times were assigned between visits, or how incomplete observation was handled. Therefore, even if a median were available, its interpretation would depend on analysis details that are not reported in the registry record.
The safety information is descriptive rather than comparative. The record reports serious adverse events affecting 13 of 105 at risk in the Paclitaxel group and reports 105 of 105 at risk for other adverse events. These entries should be read as separate registry categories; they do not establish that the groups or categories are mutually exclusive. Several serious-event terms are accompanied by percentages, but the record does not give term-specific denominators or enough detail to infer event timing, causality, or severity beyond its classification. The deaths field is null, even though Death appears among the listed serious-event terms.
In statistical terms, the most important limitation is not an unfavorable or favorable estimate but the absence of a reported efficacy estimate. The record supports a description of the design, endpoint definition, and selected safety entries. It does not support a conclusion about comparative treatment effects, nor does it provide enough information to judge the precision of the primary outcome. The study status of completed does not itself supply those missing results.
9. Statistical Methods Explained
Statistical methods matter because a clinical endpoint is produced through a sequence of choices: defining the event, determining when it occurred, deciding which observations contribute, and selecting a summary measure. The registry record names progression-free survival, provides a progression definition, and states an assessment timeframe. It does not provide a statistical analysis plan or a numerical endpoint result, so the following explains the relevant concepts generally rather than describing unreported study procedures.
What does a median time-to-event result mean?
In general, a time-to-event analysis follows participants from a defined starting point until a specified event or the end of available follow-up. The event must be clearly defined because changes to the event definition change what the estimate represents. Here, the registry defines progression through the appearance of a new lesion or an increase in existing lesions by at least 25%, according to WHO criteria. The primary outcome is described as progression-free survival, while the brief summary calls the measure time to progression. The record does not further explain how these descriptions relate in the analysis.
A median is a central point in the estimated time-to-event distribution. It is not the arithmetic mean and does not imply that all participants experience the event at a similar time. Some participants may have an event earlier or later, and some may remain without a recorded event during the observation period. The registry specifies that the median is to be reported in months, but does not report its value.
Why is a confidence interval relevant?
In general, a confidence interval communicates uncertainty around an estimate. A narrower interval indicates greater statistical precision under the method used; a wider interval indicates more uncertainty. It does not guarantee that the estimate is close to the truth, and it does not account automatically for bias from study design or measurement. The registry names a 95% confidence interval for the primary endpoint but does not report its bounds. Without those bounds, the precision of the median cannot be evaluated.
How can follow-up affect a time-to-event analysis?
In general, participants may have different lengths of observation. Some may experience the event, while others may leave observation or reach the end of follow-up before an event is documented. Survival methods can account for incomplete event observation through censoring, but the assumptions and implementation matter. The registry says assessments occur every 3 months for up to 3 years, but it does not report censoring rules, the starting point for timing, the handling of missed assessments, or the handling of deaths. These details are not reported in the registry record and should not be inferred from the endpoint name.
Scheduled assessment can also mean that progression is detected at a visit rather than at its exact onset. In general, the method used to assign an event time should be stated, particularly when assessment intervals are part of the protocol. The registry provides the assessment schedule but not the event-timing convention. This limits the ability to reproduce or fully interpret the endpoint analysis.
What does a single-group design allow?
In general, a single-group study can describe outcomes among participants receiving the studied care, subject to the quality and completeness of follow-up. It cannot estimate a randomized between-group effect when no comparator group is present. A comparison with external data would require careful attention to differences in patients, treatment eras, eligibility, and outcome ascertainment; no such comparison is reported in the registry record. Allocation is NA, masking is none, and the model is single-group, so the record does not describe random allocation or blinded outcome assessment.
The registry's note about sponsor-reported hazard ratios does not supply a hazard-ratio value in the record. A hazard ratio, in general, compares event rates over time between groups under a specified model. It is not the same as a ratio of medians and can depend on assumptions about how the relative event rates behave over follow-up. With no comparator arm or reported hazard ratio, there is no hazard-ratio result to interpret.
How should planning calculations be understood?
The registry describes sample-size planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. For time-to-event outcomes, the stated planning approach concerns the total number of events; other outcomes are described in terms of participants per arm. These assumptions describe planning illustrations, not the trial's own design rationale. They do not turn a single-group study into a two-arm comparison, and they are not observed power. The registry does not report the study's sample-size justification, and numerical planning estimates are not stated in the record summarized for this analysis.
More generally, planning calculations depend on assumptions about the effect to detect, event frequency, follow-up, allocation, and statistical method. If those assumptions differ from what occurs, the planning illustration may not describe the information ultimately available. Such calculations do not establish that an observed result is precise, nor do they replace reporting the actual effect estimate and its uncertainty.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 2 outcome measures, with progression-free survival as the primary outcome and toxicity as a secondary outcome. It reports 0 analyses. No statistical analysis plan, prespecified testing hierarchy, or adjustment for multiple comparisons is described in the registry record. It is therefore not possible to determine how multiple outcomes or analyses were handled, or whether any result was designated as confirmatory.
In general, examining multiple outcomes or multiple analyses can increase the chance of finding an apparently notable result by chance. Methods such as a prespecified hierarchy or multiplicity adjustment can address particular testing strategies, but the appropriate method depends on the study plan. The record does not report whether such methods were planned or used. No p-value for the primary endpoint is reported, so there is no reported significance result to interpret.
Missing-data procedures and analysis populations are also not reported in the registry record. The record does not say whether the primary outcome analysis included all enrolled participants, only those with evaluable follow-up, or another defined population. It does not describe withdrawals, missed assessments, loss to follow-up, imputation, or the censoring rules for time-to-event analysis. Those omissions matter because incomplete follow-up can affect both the estimate and its uncertainty.
The timeframe of every 3 months for up to 3 years gives an assessment schedule, not a complete account of follow-up completeness or analysis handling. The completed status likewise does not tell readers whether every planned assessment or analysis was completed. Without the analysis population and missing-data methods, the primary endpoint cannot be independently reconstructed from the registry record.
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 | 13 | 105 | 12.4% |
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 | 105 of 105 |
Most frequent serious adverse event terms
| Event term | Organ system | Paclitaxel |
|---|---|---|
| deterioration of general condition | General disorders | 5 of 105 |
| Ileus | Gastrointestinal disorders | 3 of 105 |
| Nausea | Gastrointestinal disorders | 2 of 105 |
| Suspected thrombosis | Vascular disorders | 2 of 105 |
| embolism | Vascular disorders | 2 of 105 |
| Death | General disorders | 1 of 105 |
| Disease progression | General disorders | 1 of 105 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Paclitaxel |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | 105 of 105 |
Serious events with the highest arm-level rate: deterioration of general condition (4.8%), ileus (2.9%), nausea (1.9%), suspected thrombosis (1.9%), embolism (1.9%).
The registry lists a Paclitaxel group with 105 participants at risk for serious adverse events and 13 affected. For other adverse events, it lists 105 at risk and 105 affected. These are registry entries for separate categories; the record does not explain whether or how the categories overlap. The figures should not be interpreted as a comparison between groups, because the study has a single-group model and no comparator arm.
The listed serious-event terms include deterioration of general condition at 4.8%, Ileus at 2.9%, Nausea at 1.9%, Suspected thrombosis at 1.9%, embolism at 1.9%, and Death at 1.0%. These are term-specific percentages as recorded; the registry does not report the denominators behind each percentage or define whether terms refer to participants, events, or another counting convention.
The deaths field is null. The Death term among serious-event entries should not be treated as a complete death count, and the available record does not clarify its relationship to that null field. The registry also does not report timing, duration, attribution, or event-level detail for these entries. The figures are descriptive safety information and do not establish that an event was caused by treatment.
12. What the Result Does, and Does Not, Mean
The record establishes that a completed phase 2, single-group study was registered with progression-free survival as its primary outcome. It specifies a progression definition based on WHO criteria, an assessment schedule of every 3 months for up to 3 years, and a median with a 95% confidence interval as the intended form of the primary result. It also records toxicity as a secondary outcome and includes selected adverse-event entries.
Those details do not establish the observed progression-free survival result. The numerical median and confidence interval are not reported in the registry record, and no treatment-effect estimate is reported. The missing result means readers cannot determine the magnitude of the outcome or how precisely it was estimated from the posted information. It would be inappropriate to infer benefit or lack of benefit from the endpoint definition, study completion status, or safety entries.
The single-group design also limits what the outcome can mean. Even if a numerical time-to-event estimate were reported, it would describe the studied group under the analysis used; without a randomized comparator, it would not identify a causal difference between treatments. A comparison with another study would not resolve that limitation automatically, because patient populations, follow-up, and outcome measurement can differ.
The title and intervention listing do not provide a complete account of treatment administration. The registry identifies paclitaxel as the intervention and mentions additional drugs in the official title, while leaving the arm description blank. Dose, schedule, treatment completion, and adherence are not reported. Those details cannot be inferred from the title alone.
The serious adverse-event entries likewise do not provide a full safety comparison. The record lists counts and selected percentages, but does not explain term-specific denominators or event attribution; it also has a null deaths field alongside a Death term. These entries are useful as descriptive registry information, not as proof of causation or a comparative estimate of harm. Overall, the registry supports understanding the study's broad design and endpoint, while leaving its primary numerical result and several key analytic details unreported.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the distinction between a clearly named outcome and a reported outcome estimate. The registry identifies progression-free survival, specifies a progression threshold using WHO criteria, gives an assessment schedule, and names a median and 95% confidence interval as the summary. Yet the numerical median and interval are not reported in the registry record. Without the estimate and its uncertainty, readers cannot assess the observed endpoint result, regardless of how clearly the outcome is defined.
The single-group structure also illustrates why design determines the scope of statistical interpretation. A within-group time-to-event description is not the same as an estimate of treatment effect against a control. Allocation is NA, masking is none, and no comparator is listed. Thus, the record does not support a randomized comparison. That distinction remains important even when a study has a formal phase designation or a completed status.
The registry also shows why treatment descriptions need to be read carefully. The official title names carboplatin, Taxol® therapy, and epoetin alfa, but the intervention listing names paclitaxel and the arm description is blank. This leaves uncertainties about treatment components and their use. Statistical interpretation depends on knowing what was actually administered and to whom; the title alone does not provide that detail.
Finally, the safety entries demonstrate the importance of defining denominators and counting rules. The registry gives at-risk and affected entries, selected term percentages, and a null deaths field, but does not explain all relationships among these entries. Careful reading distinguishes what is directly recorded from what cannot be concluded. The key statistical lesson is that design, outcome definition, numerical estimates, and analysis details all contribute to interpretation; the available record is more complete about some of these than others.
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 primary outcome result is not reported in the registry record. Although the endpoint is specified as a median with a 95% confidence interval, neither the median nor the interval is available. No numerical hazard ratio or other treatment-effect estimate is reported. This prevents assessment of the outcome's magnitude and precision.
The study is single-group, has allocation recorded as NA, and has no listed comparator. It therefore does not provide a randomized treatment contrast. Masking is listed as none, and the record does not explain whether outcome assessors were otherwise blinded. The registry does not report a detailed analysis plan, analysis population, censoring rules, or handling of missing assessments and deaths.
The intervention details are incomplete. The official title mentions carboplatin, Taxol® therapy, and epoetin alfa, while the intervention listing identifies paclitaxel and the arm description is blank. Treatment dose, schedule, duration, adherence, and the actual use of each title-listed component are not reported in the registry record. Baseline characteristics and further population details are also not reported.
Safety interpretation is limited by the lack of term-specific denominators and event-level detail. The deaths field is null while Death appears as a serious-event term; the record does not explain this discrepancy. The meaning of the other adverse-event category and its relationship to the serious-event category are not described. These limitations mean the reported entries should be treated as registry descriptions rather than complete comparative safety estimates.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Taxol Carboplatin and Erythropoetin — NCT00158379.
- Registry record last updated 2017-02-06; status last verified 2016-12.
- Results first posted 2016-11-25.
- 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
NCT00158379 is a completed phase 2, single-group study sponsored by the North Eastern German Society of Gynaecological Oncology. The record concerns ovarian cancer and lists enrollment of 105 participants. Its official title describes female patients with advanced disease, from FIGO IA/G3 through IV. The study start is 2003-07, and primary completion is recorded as 2008-04.
The primary endpoint is progression-free survival, with progression defined by WHO criteria and assessments stated to occur every 3 months for up to 3 years. The intended summary is a median in months with a 95% confidence interval, but the numerical result is not reported in the registry record. Toxicity is listed as a secondary outcome. The record contains selected adverse-event counts and percentages, but lacks details needed for a complete safety interpretation.
No comparator is listed, and the record does not provide the primary outcome estimate, a treatment-effect estimate, or key analysis details. The registry therefore describes the broad study design and endpoint more fully than it reports the outcome results.