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 Study to Evaluate Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel to Treat Metastatic Pancreatic Cancer (NCT01851174), a na phase 2 study. The primary outcome is Overall Survival Based on Toxicity Profile of Adverse Events..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01851174 |
| Phase | Phase 2 |
| Condition | Pancreatic Carcinoma Non-resectable, Stage IV Pancreatic Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 15 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Western Regional Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes people with surgically unresectable or metastatic pancreatic cancer, including stage IV disease. Its official title specifies first-line treatment. The primary-outcome population details were not captured, so further eligibility or analysis-population criteria are not reported in the registry record.
Intervention
The study used gemcitabine plus nab-paclitaxel on a bi-weekly schedule. The listed regimen administered both drugs intravenously on days 1 and 15, every 28 days.
Comparator
There was no comparator arm. The record identifies a single-group study, with allocation listed as NA and masking as none. It therefore does not describe a randomized or controlled comparison of dosing schedules.
Primary question
The stated aim was to assess whether bi-weekly dosing could reduce treatment-related hematological and non-hematological adverse events. The primary-outcome title refers to overall survival based on the toxicity profile, with a one-year timeframe. The registry record does not report the outcome values or clarify how this endpoint was defined and analyzed.
In practical terms, the study concerns the safety profile of a particular dosing schedule in the stated cancer population, alongside an endpoint title that invokes overall survival. Without reported outcome results, it is not possible to assess the observed survival experience or the frequency and severity of treatment-related adverse events. The single-group design also means that any observed outcomes would describe participants receiving this regimen; they would not by themselves establish how those outcomes compare with another schedule or treatment.
3. Trial Design
The registry classifies NCT01851174 as a phase II, single-group study. It lists allocation as NA and masking as none. No randomized allocation or concurrent control group is described, so the design does not support a like-for-like comparison between treatment schedules. The registry lists enrollment as 15.
The study evaluated gemcitabine with nab-paclitaxel for first-line treatment of surgically unresectable or metastatic pancreatic cancer. The regimen description specifies intravenous administration of gemcitabine at 1,000 mg/m^2 and nab-paclitaxel at 125 mg/m^2 on days 1 and 15, every 28 days. These are the listed dosing details; further treatment rules, dose modifications, and adherence information are not reported in the registry record.
The study start is recorded as 2013-02, and primary completion as 2015-01. Its status is listed as terminated. The reason for termination and any consequences for recruitment, follow-up, or outcome collection are not reported in the registry record. A termination status alone does not explain why the study ended or establish whether planned data collection was completed.
The stated purpose was to determine whether adverse events could be decreased by moving to a bi-weekly schedule. However, there is no comparison group receiving another schedule. Any assessment of a decrease would therefore require a comparison not documented in this single-group record; the registry does not report such an analysis or its basis. The record names progression-free survival time as a secondary outcome, but does not give its result or analysis details. Further protocol elements, including the planned sample-size justification and statistical analysis plan, are not reported in the registry record.
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 | Gemcitabine and Nab-Paclitaxel |
|---|---|
| STARTED | 15 |
| COMPLETED | 15 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: The information required here was not captured. The investigator(s) are no longer at the site and no additional information or instruction was left.
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: The information required here was not captured. The investigator(s) are no longer at the site and no additional information was left.
| Characteristic | Unit | Gemcitabine and Nab-Paclitaxel |
|---|---|---|
| Participants analysed | 0 | |
| Age, Categorical: <=18 years | — | |
| Age, Categorical: Between 18 and 65 years | — | |
| Age, Categorical: >=65 years | — | |
| Sex: Female, Male: Female | — | |
| Sex: Female, Male: Male | — | |
| Region of Enrollment: United States | participants | — |
6. Primary Endpoint
The registry lists the primary outcome as Overall Survival Based on Toxicity Profile of Adverse Events., measured over One year.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary-outcome title is Overall Survival Based on Toxicity Profile of Adverse Events, and the timeframe is listed as one year. Its description states that the study aimed to determine the toxicity profile, specifically a decrease in hematological and non-hematological treatment-related adverse events, with bi-weekly dosing of gemcitabine plus nab-paclitaxel. The population information required for the outcome was not captured, and the registry record does not provide a numerical endpoint definition, event-counting rules, or reported result.
In general, overall survival concerns time until death from any cause. It is often used in clinical trials because it is a clinically important time-to-event outcome. A toxicity profile addresses a different dimension: the kinds and frequency of harms observed during treatment. Combining these ideas in an outcome title does not itself specify how they were linked analytically. The registry record does not clarify whether survival and toxicity were separate measures, whether a toxicity-based subgroup or association was intended, or how follow-up and censoring were handled.
The record lists progression-free survival time as a secondary outcome, but supplies no operational definition, estimate, or uncertainty measure. No primary or secondary outcome values are reported. Consequently, the endpoint description explains the study’s stated focus, but does not permit an estimate of survival, a toxicity rate, or the precision of either.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a phase II, single-group study with enrollment listed as 15 and status listed as terminated. It describes bi-weekly gemcitabine plus nab-paclitaxel for first-line treatment of surgically unresectable or metastatic pancreatic cancer. It does not report a primary-outcome estimate, a secondary-outcome estimate, or an inferential analysis. The primary-outcome population was not captured, and the record does not explain how the endpoint title relating overall survival to toxicity was operationalized.
These omissions place a firm limit on interpretation. No survival time, event count, adverse-event rate, effect estimate, or confidence interval is reported. Without an estimate and its uncertainty, readers cannot judge the direction, magnitude, or precision of an observed result. The absence of results in the registry record should not be interpreted as a finding of no effect, no toxicity, or no deaths; it means that the relevant results are not reported in the registry record.
The adverse-event entries require particular caution. The listed group has 0 at risk and 0 affected for serious adverse events, and 0 at risk and 0 affected for other adverse events. Deaths are not reported in the registry record. The zero at-risk entries do not furnish a usable participant denominator for interpreting the zero affected counts. They therefore cannot establish that no adverse events occurred among study participants. The registry record does not explain whether these entries reflect incomplete outcome reporting, absent data, or another reporting circumstance.
The single-group design is also important. Even if outcomes had been reported, observations in one treatment group would describe that group; they would not provide a randomized estimate of what would have happened under a different schedule. The stated aim of reducing adverse events through a schedule change requires a relevant comparator to estimate a schedule difference directly. No such comparator is described, and the record does not report an external comparison or adjustment that could address this limitation.
In general, a confidence interval expresses the range of estimates compatible with the data and the statistical model, while also indicating precision. Neither an estimate nor a confidence interval is reported for the primary outcome. The record also lists no analyses. Accordingly, there is no posted statistical result from which to assess whether the study’s stated safety or survival questions were answered. The termination reason, study-specific analysis plan, and details of outcome follow-up are not reported in the registry record, so the completeness and context of the unavailable results cannot be determined.
9. Statistical Methods Explained
What does a single-group design tell us?
The registry describes one treatment group rather than a randomized comparison. In general, a single-group study can characterize outcomes observed among participants receiving a regimen, provided outcome definitions and follow-up are sufficiently clear. It cannot, on its own, isolate the effect of the regimen from the natural course of illness, other care, participant selection, or changes over time. A difference from an external benchmark, if one were used, would require careful justification because the populations, outcome definitions, and follow-up could differ. No external benchmark or comparative analysis is reported in the registry record.
For this study, the stated intention to determine whether adverse events could be decreased by changing to a bi-weekly schedule implies a comparison of schedules. Yet the record describes a single group and no concurrent schedule comparator. Thus, the design information does not document a direct estimate of a decrease relative to another schedule. This is a design limitation, not a claim about what the observed data would show.
How are time-to-event outcomes usually analyzed?
In general, overall survival and progression-free survival are time-to-event outcomes. The analysis records the time until a defined event, while accounting for participants whose event has not been observed by the end of follow-up or who leave observation earlier. Such observations are commonly treated as censored under assumptions about why follow-up ended. A survival curve can describe the estimated probability of remaining event-free over time; a median survival time can summarize when the estimated curve reaches a specified point. A hazard ratio, when used, compares event rates over follow-up under a model and requires a comparison group or a defined contrast.
These are general methods, not methods confirmed for this study. The registry record does not give a survival estimate, event definition, censoring rules, follow-up distribution, model, or statistical analysis. The one-year timeframe attached to the primary outcome does not, by itself, define the estimator or show that participants were followed for the same duration. The secondary outcome is named as progression-free survival time, but its operational definition and analysis are not reported in the registry record.
How should toxicity counts be interpreted?
In general, an adverse-event frequency needs a clear event definition, a period of observation, and a denominator describing the participants at risk or the amount of exposure. Severity grading and attribution to treatment are also relevant when the question concerns treatment-related harms. Repeated events in one participant may be counted differently from the number of participants who experience at least one event, so the counting rule matters. For a treatment schedule comparison, consistent surveillance and definitions across groups are essential.
The registry’s adverse-event entries list zero participants at risk and zero affected for both serious and other adverse events, while deaths are not reported. Because the at-risk entries do not provide a usable denominator, the zero affected entries cannot be interpreted as evidence that the regimen produced no adverse events. The record does not explain the meaning of these entries, nor does it report event definitions, grades, exposure time, or attribution procedures. These missing details prevent a meaningful reconstruction of a toxicity analysis.
What does uncertainty quantify?
In general, an estimate is more informative when accompanied by a measure of uncertainty, such as a confidence interval. The interval indicates how compatible a range of values is with the observed data and the assumptions of the method. A wide interval signals limited precision, while a narrow interval indicates greater precision under the same assumptions. A p-value, when reported, addresses compatibility with a specified null hypothesis under a statistical model; it does not measure clinical importance or prove that a hypothesis is true.
No primary or secondary estimates, confidence intervals, or p-values are reported in the registry record. Consequently, neither the size nor precision of the study’s outcomes can be evaluated. The record also lists no analyses. Specific model choices, adjustments, handling of incomplete observations, and any interim analyses are not reported in the registry record.
What can planning calculations add?
In general, sample-size planning uses assumptions about the outcome, anticipated effect, variability or event rate, significance level, allocation, and desired power. A planning illustration based on an observed effect is a retrospective scenario, not evidence that the original study was designed with that effect in mind. It is not observed power and cannot substitute for a confidence interval or a reported outcome analysis. The registry record does not report the study’s own sample-size justification or planned statistical assumptions. Any planning illustration should therefore be kept separate from claims about the actual design and results.
10. Multiplicity, Missing Data and Analysis Populations
The registry names a primary outcome concerning overall survival based on toxicity and lists progression-free survival time as a secondary outcome. It does not report results for either. The record does not describe whether additional outcomes or analyses were planned, how outcomes were prioritized, or whether any adjustment for multiple comparisons was intended. The statistical plan is not reported in the registry record.
In general, multiplicity arises when multiple hypotheses or outcomes are tested. Repeated testing can increase the chance of finding at least one apparently notable result by chance. Methods such as prespecifying a primary endpoint, controlling a family-wise error rate, or treating secondary analyses as exploratory can help readers understand the evidential status of results. Which approach is appropriate depends on the trial’s aims and planned analyses. No such approach can be attributed to this study from the registry information.
The record does not report missing-data methods or the extent and reasons for missing outcome information. The primary outcome description explicitly states that the required population information was not captured. The adverse-event entries list zero at risk and zero affected, and deaths are not reported. Those entries do not reveal whether outcome data were absent, whether collection was incomplete, or whether the values represent a different reporting circumstance. No missingness assumptions, imputation methods, censoring rules, or sensitivity analyses are reported in the registry record.
The analysis population is also not specified beyond the statement that the primary-outcome population information was not captured. It is therefore not possible to determine whether analyses were intended to include all enrolled participants, only those who began treatment, or another defined group. These gaps limit reproducibility and make it difficult to assess whether reported outcomes, if available elsewhere, would represent the same population across endpoints.
11. What the Result Does, and Does Not, Mean
The record establishes that a phase II, single-group study evaluated a bi-weekly regimen of gemcitabine plus nab-paclitaxel in first-line treatment of surgically unresectable or metastatic pancreatic cancer. It lists enrollment as 15, a one-year timeframe for the primary outcome, a secondary outcome of progression-free survival time, and a terminated status. The primary-outcome description states a focus on treatment-related hematological and non-hematological adverse events, while the title also refers to overall survival.
Those details describe the study’s registration and stated objectives; they do not provide evidence about the observed survival or toxicity outcomes. No numerical outcome results or analyses are reported. The zero entries for adverse-event risk and affected counts cannot be read as proof that no events occurred, particularly because the listed at-risk values do not give a usable denominator. Deaths are not reported in the registry record.
The design also does not establish whether this schedule reduces adverse events relative to a different schedule. A single-group study does not contain the concurrent comparison needed to estimate that contrast directly. The record does not report a separate comparator or a comparative analysis. This does not establish that the regimen is beneficial or harmful; it identifies what the registered design and posted results can support.
In general, statistical evidence is strongest when an outcome is clearly defined, results are reported with uncertainty, and the analysis follows a transparent plan. Here, endpoint details, analysis methods, outcome estimates, and the reason for termination are not reported in the registry record. The appropriate conclusion is therefore limited: the record describes the study’s purpose and design, but it does not allow readers to judge the magnitude or precision of its survival or toxicity outcomes.
12. Why This Trial Matters Statistically
This study raises a useful statistical distinction between observing outcomes under a regimen and estimating a treatment-schedule effect. Its stated objective concerns whether moving to bi-weekly dosing could decrease adverse events, but the registry describes a single group with no schedule comparator. A one-group description can characterize what was recorded for that group, but it cannot by itself distinguish a schedule effect from other explanations for observed outcomes.
The record also illustrates why endpoint definitions matter. The primary-outcome title combines overall survival with a toxicity profile, while its description focuses on treatment-related hematological and non-hematological adverse events. The required population information was not captured. Without a clear definition of the outcome and its analysis population, readers cannot know precisely what quantity the primary result was intended to estimate.
Reporting the denominator is central to interpreting adverse-event counts. The posted entries show zero at risk and zero affected for serious and other adverse events, but those values do not establish that no events occurred. A reader needs to know who was observed, for how long, and what event-counting rules were used. The record does not report those details or a toxicity estimate.
Finally, this terminated study has no reported outcome analyses in the registry record. The missing results prevent assessment of effect size and statistical precision; they should not be mistaken for a null finding. For biostatisticians and clinical researchers, the record underscores the value of coherent endpoint definitions, a design aligned to the comparative question, transparent denominators, and accessible results with uncertainty measures.
13. 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 limitation is the absence of reported outcome results and analyses. The registry lists no analyses, and it does not provide an estimate or uncertainty measure for overall survival, toxicity, or progression-free survival time. The primary-outcome population information was not captured, and the endpoint title does not make clear how overall survival and toxicity were connected in the intended analysis.
The study is described as single-group, with allocation listed as NA and masking as none. No control group is documented. This prevents a direct randomized comparison of the bi-weekly schedule with another schedule, which is central to interpreting the stated aim of decreasing adverse events through a schedule change.
The adverse-event entries list zero at risk and zero affected in both serious and other categories. Without a usable denominator, event definitions, exposure information, or an explanation of the entries, these values cannot support a rate or a conclusion that no events occurred. Deaths are not reported in the registry record. The record does not clarify whether outcome collection was incomplete or how missing observations were handled.
The study status is terminated, but the reason is not reported in the registry record. It is therefore not possible to determine how termination affected recruitment, follow-up, or the availability of results. The registry also does not report the study-specific sample-size justification, planned analysis methods, analysis population, or any missing-data procedures. These limitations concern what can be learned from the registry record; they do not establish what occurred in the study beyond its recorded design and status.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Study to Evaluate Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel to Treat Metastatic Pancreatic Cancer — NCT01851174.
- Registry record last updated 2018-02-07; status last verified 2018-01.
- Results first posted 2017-12-04.
- 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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17. Record Summary
NCT01851174 is registered as a phase II, single-group study of bi-weekly gemcitabine plus nab-paclitaxel for first-line treatment of surgically unresectable or metastatic pancreatic cancer. The listed regimen administers both drugs intravenously on days 1 and 15, every 28 days. The record lists enrollment as 15, study start as 2013-02, primary completion as 2015-01, and status as terminated.
The stated focus is treatment-related hematological and non-hematological adverse events. The primary-outcome title refers to overall survival based on toxicity, with a one-year timeframe; progression-free survival time is listed as a secondary outcome. The record reports no outcome analyses or numerical results. It does not report a comparator, a termination reason, the primary-outcome population, or the study-specific statistical plan. The adverse-event entries list zero at risk and zero affected, but do not provide a usable basis for interpreting event occurrence; deaths are not reported in the registry record.