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 of Ruxolitinib in Pancreatic Cancer Patients (Janus 1) (NCT02117479), a randomized phase 3 study. The primary outcome is Overall Survival (OS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02117479 |
| Phase | Phase 3 |
| Condition | Pancreatic Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 321 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Incyte Corporation |
| Results posted | Yes |
2. Clinical Question
Population
Participants with advanced or metastatic adenocarcinoma of the pancreas who had failed or were intolerant to first-line chemotherapy. The stated intent-to-treat population consisted of all participants randomized to the study.
Intervention
Ruxolitinib given in combination with capecitabine.
Comparator
Placebo given in combination with capecitabine.
Primary question
Whether the addition of ruxolitinib to capecitabine affected overall survival, measured from randomization until death due to any cause. The registry describes the endpoint as based on deaths through 6 months or the data cutoff, 11FEB2016.
This is a comparison of treatment strategies that differ by the addition of ruxolitinib or placebo to capecitabine. Because capecitabine appears in both arms, the intended contrast concerns the added study drug rather than capecitabine versus no treatment. The registry record does not report arm-specific survival results, an estimated treatment effect, or a confidence interval for the primary endpoint, so the size and precision of any between-arm difference cannot be assessed from the posted record.
The study also lists progression-free survival, the percentage of participants achieving progression-free survival, objective response rate, duration of response, and treatment-emergent adverse events as secondary outcomes. These outcomes address different aspects of disease status and safety; they are not substitutes for the primary overall-survival question. The registry record does not provide the numerical results for those secondary outcomes in the registry record for this account.
3. Trial Design
JANUS 1 is described as a randomized, double-blind, parallel phase 3 study. Randomization assigns participants to treatment groups by chance, which is intended to support a fair comparison by limiting systematic differences in baseline characteristics. The parallel design means participants are assigned to one study group rather than crossing between the two treatments. Double masking indicates that the study was recorded as double-blind; the registry does not specify which roles were masked or provide further details about masking procedures.
The two recorded groups were ruxolitinib plus capecitabine and placebo plus capecitabine. The study title and population description identify people with advanced or metastatic pancreatic adenocarcinoma after failure of, or intolerance to, first-line chemotherapy. The registry records 321 participants enrolled. It does not establish in the information that the enrollment count equals the number randomized or the number included in every outcome analysis. The stated intent-to-treat population is all participants randomized to the study.
The study began in 2014-03, had primary completion in 2016-02, and is recorded as terminated. These registry fields describe study status and timing, but do not explain why the study was terminated or how termination affected data collection or analyses. The reason for termination and any consequences for the planned analyses are not reported in the registry record.
Overall survival was the primary outcome. Its recorded timeframe runs from randomization until death due to any cause, with observation described up to 6 months or the data cutoff 11FEB2016. The outcome description also says it is reported based on the number of deaths from randomization up to 6-months or to that cutoff. Details such as the exact analysis date for each participant, follow-up procedures, allocation ratio, stratification factors, and the protocol’s planned analysis methods 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.
Before assignment: Treatment was started as soon as possible after randomization (within 3 days) and consisted of continuous 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and ruxolitinib/placebo was self-administered for the entire cycle.
Overall Study
| Stage | Ruxolitinib Plus Capecitabine | Placebo Plus Capecitabine |
|---|---|---|
| STARTED | 161 | 160 |
| COMPLETED | 5 | 4 |
| NOT COMPLETED | 156 | 156 |
Reasons for not completing this period:
| Reason | Ruxolitinib Plus Capecitabine | Placebo Plus Capecitabine |
|---|---|---|
| Death | 13 | 8 |
| Adverse Event | 8 | 16 |
| Subject decision | 8 | 9 |
| Disease progression | 104 | 108 |
| Noncompliance with study treatment | 1 | 0 |
| Study terminated by the sponsor | 4 | 6 |
| Physician Decision | 7 | 2 |
| Other unspecified | 11 | 7 |
Analysis population for the primary outcome, as defined in the registry: The intent-to-treat (ITT) population consisted of all participants randomized to the study.
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 intent-to-treat (ITT) population consisted of all participants randomized to the study.
| Characteristic | Unit | Ruxolitinib Plus Capecitabine | Placebo Plus Capecitabine | Total |
|---|---|---|---|---|
| Participants analysed | 161 | 160 | 321 | |
| Age, Continuous | years | 67.3 (SD 9.35) | 65.6 (SD 9.55) | 66.4 (SD 9.48) |
| Age, Customized: ≤ 65 years | participants | 65 | 68 | 133 |
| Age, Customized: > 65 years | participants | 96 | 92 | 188 |
| Sex: Female, Male: Female | Participants | 66 | 64 | 130 |
| Sex: Female, Male: Male | Participants | 95 | 96 | 191 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Survival (OS), measured over Randomization until death due to any cause; up to the data cutoff 11FEB2016..
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
Overall survival measures the time from randomization until death from any cause. The registry describes the posted endpoint in terms of the number of deaths, with follow-up from randomization up to 6 months or the data cutoff 11FEB2016. The intent-to-treat population is defined as all participants randomized to the study.
General statistical context: overall survival is a time-to-event endpoint. It retains information about when deaths occur, rather than only whether a participant had died at a single assessment. In a complete time-to-event analysis, participants who have not died by the end of their observed follow-up may contribute information up to that point without being treated as if they had died. This is commonly handled through censoring, although the registry record does not report the method used for this study’s analysis.
Overall survival is used in clinical trials because death is a clearly defined event and does not depend on an investigator’s interpretation of a scan or symptom. That general advantage does not resolve questions about follow-up completeness, analysis methods, or the precision of a treatment comparison. The registry record does not provide a survival estimate, a measure of uncertainty, or the numerical death results by group. It therefore does not support a quantitative interpretation of the primary endpoint from the posted information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies overall survival as the primary outcome and defines the target population as all participants randomized to the study. However, the available record does not report arm-specific deaths, survival estimates, a treatment-effect estimate, a confidence interval, or a significance test. The primary result therefore cannot be quantified from the registry information available for this account. No conclusion about the direction, magnitude, or precision of a difference between the study groups can be drawn from the endpoint description alone.
The record describes overall survival as deaths counted from randomization through 6 months or the data cutoff 11FEB2016. A count over a stated period is not, by itself, enough to characterize the full pattern of time-to-event data. Interpretation would also depend on how long participants were followed, how participants without an observed death were handled, whether follow-up was comparable between groups, and which statistical summary was used. Those details are not reported in the registry record.
The study is recorded as terminated, but the reason for termination and its relationship to the primary outcome are not reported. Termination alone does not establish whether a study stopped early for benefit, harm, recruitment, operational reasons, or another cause. It also does not reveal whether the planned analysis was completed as intended. Those explanations must not be inferred from the status field.
The secondary outcomes include progression-free survival, a percentage achieving progression-free survival, objective response rate, duration of response, and treatment-emergent adverse events. The listed outcome names indicate what the study tracked, not what the results were. Numerical secondary-outcome results and their uncertainty are not reported in the registry record. The registry lists 6 outcome measures and 2 analyses, but does not provide enough detail to interpret what analyses correspond to those entries.
The posted adverse-event information includes counts of participants with serious events and other events in each group, as well as percentages for several serious-event terms. These figures describe recorded safety events, not the primary survival comparison. They do not provide a complete account of event severity, timing, causal attribution, exposure duration, or uncertainty. The available numbers should therefore be read as descriptive registry results, not as a comprehensive basis for comparing safety between the groups.
9. Statistical Methods Explained
What is reported
The study is described as randomized, double-blind, and parallel, with overall survival as the primary endpoint. Its population definition specifies the intent-to-treat population as all randomized participants. The registry record does not report the statistical analysis plan, the method used to estimate the treatment effect, the method used to calculate uncertainty, or whether adjustments were planned or performed. A design label does not supply those missing analysis details.
What does a time-to-event endpoint retain?
General statistical explanation: a time-to-event outcome includes both whether an event occurred and the time until it occurred. This differs from a simple event count because participants can have different lengths of observation. If a participant has no observed event before follow-up ends, censoring methods can use the information available up to the last observed time without assigning an unobserved event. The registry record does not state how censoring was handled in JANUS 1, nor does it report a survival curve or another time-to-event summary.
General statistical explanation: a treatment comparison for time-to-event data may be expressed in several ways, each answering a related but distinct question. A relative rate comparison, a difference in survival probability at a specified time, or a comparison of time-to-event distributions does not have the same interpretation. The registry record does not identify which estimand or summary was used for the primary result. Without that information and the numerical results, no treatment-effect estimate can be reconstructed.
Why do confidence intervals matter?
General statistical explanation: a confidence interval describes the uncertainty around an estimate under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, while the interval’s location helps show which effect sizes remain compatible with the data and method. A point estimate alone can conceal substantial uncertainty. JANUS 1’s registry record does not report a primary-effect estimate or its confidence interval, so precision cannot be evaluated from the available primary-outcome information.
What can a significance test establish?
General statistical explanation: a p-value measures how incompatible the observed data are with a specified null model, assuming the model and analysis choices are appropriate. It does not measure the probability that the null hypothesis is true, the probability that a result is due to chance, or the size of an effect. A p-value is most informative when read alongside the effect estimate, confidence interval, and analysis plan. A primary p-value is not reported in the registry record.
For planning illustrations, the recorded assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The illustrated effect is a stated fraction of the observed effect. Time-to-event planning uses the total number of events; other planning calculations use participants per arm. These are planning illustrations rather than observed power, and no illustration should be interpreted as the trial’s original design justification. The registry record does not report the trial’s own sample-size justification. Since the primary result needed to define an observed effect is not reported, no planning value or effect fraction can be interpreted numerically from the available information.
What does over-dispersion mean?
General statistical explanation: over-dispersion occurs when observed variability is greater than a statistical model expects. If unaccounted for, it can make uncertainty appear smaller than it is. The primary outcome is recorded as a count of participants with an event, and no dispersion measure is specified. The registry record does not report whether over-dispersion was assessed or whether a model requiring such an assessment was used. It would be inappropriate to assume a particular model or diagnose over-dispersion from the event description alone.
What can recalculation show?
General statistical explanation: a recalculated result based on posted summary statistics is an unadjusted calculation using those summaries. It may not reproduce a sponsor’s analysis, which can use participant-level data, planned covariates, censoring rules, or other methods not recoverable from aggregate counts. No recalculated primary comparison is presented in the registry record, and the registry record does not supply the primary summary statistics needed to form one. Any planning calculation is distinct from observed power and cannot replace the trial’s own analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary outcome of overall survival and secondary outcomes that include progression-free survival, the percentage achieving progression-free survival, objective response rate, duration of response, and treatment-emergent adverse events. It records 6 outcome measures and 2 analyses. The record does not explain how those analyses map to the outcomes, whether additional comparisons or time points were assessed, or which results were considered confirmatory.
General statistical explanation: testing multiple outcomes, groups, time points, or subgroups can increase the chance of obtaining at least one apparently unusual result under a null model. A prespecified testing hierarchy or multiplicity adjustment can help control that issue, but the appropriate approach depends on the study’s objectives and analysis plan. A multiplicity strategy, any interim analyses, and any correction for multiple testing are not reported in the registry record. No adjustment should be assumed.
The intent-to-treat population is stated to include all randomized participants. That definition identifies the population for the primary analysis in principle, but the record does not report how many randomized participants contributed to each outcome, whether any participants were excluded from analyses, or how missing outcome data were handled. The extent and reasons for missingness, follow-up completeness, and sensitivity analyses are not reported in the registry record.
General statistical explanation: missing data can affect interpretation when the probability of a missing observation is related to a participant’s outcome or group. Complete-case analysis, imputation, and other approaches rely on different assumptions; none can be attributed to this study from the record. The registry record also does not report whether missingness differed between treatment groups. These gaps limit assessment of how well the reported analysis, if any, represents all randomized participants.
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 |
|---|---|---|---|
| Ruxolitinib Plus Capecitabine | 94 | 153 | 61.4% |
| Placebo Plus Capecitabine | 83 | 154 | 53.9% |
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 |
|---|---|
| Ruxolitinib Plus Capecitabine | 147 of 153 |
| Placebo Plus Capecitabine | 145 of 154 |
Most frequent serious adverse event terms
| Event term | Organ system | Ruxolitinib Plus Capecitabine | Placebo Plus Capecitabine |
|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | 6 of 153 | 19 of 154 |
| Vomiting | Gastrointestinal disorders | 7 of 153 | 4 of 154 |
| Pneumonia | Infections and infestations | 4 of 153 | 7 of 154 |
| Dehydration | Metabolism and nutrition disorders | 7 of 153 | 4 of 154 |
| Sepsis | Infections and infestations | 5 of 153 | 5 of 154 |
| Diarrhoea | Gastrointestinal disorders | 5 of 153 | 4 of 154 |
| Nausea | Gastrointestinal disorders | 4 of 153 | 5 of 154 |
| Pyrexia | General disorders | 8 of 153 | 1 of 154 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 5 of 153 | 4 of 154 |
| Anaemia | Blood and lymphatic system disorders | 4 of 153 | 3 of 154 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Ruxolitinib Plus Capecitabine | Placebo Plus Capecitabine |
|---|---|---|---|
| Fatigue | General disorders | 47 of 153 | 50 of 154 |
| Nausea | Gastrointestinal disorders | 45 of 153 | 49 of 154 |
| Abdominal pain | Gastrointestinal disorders | 36 of 153 | 49 of 154 |
| Diarrhea | Gastrointestinal disorders | 42 of 153 | 36 of 154 |
| Decreased appetite | Metabolism and nutrition disorders | 30 of 153 | 47 of 154 |
| Vomiting | Gastrointestinal disorders | 30 of 153 | 46 of 154 |
| Anemia | Blood and lymphatic system disorders | 45 of 153 | 22 of 154 |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | 37 of 153 | 26 of 154 |
| Constipation | Gastrointestinal disorders | 33 of 153 | 27 of 154 |
| Oedema peripheral | General disorders | 18 of 153 | 35 of 154 |
Serious events with the highest arm-level rate: abdominal pain (12.3%), pyrexia (5.2%), vomiting (4.6%), dehydration (4.6%), pneumonia (4.5%).
The posted serious-event counts are 94 of 153 participants at risk in the ruxolitinib plus capecitabine group and 83 of 154 at risk in the placebo plus capecitabine group. The other-event counts are 147 of 153 and 145 of 154, respectively. These are descriptive counts as recorded; they are not, by themselves, an adjusted comparison or a measure of uncertainty.
The registry also lists serious-event terms with percentages: abdominal pain, 12.3%; pyrexia, 5.2%; vomiting, 4.6%; dehydration, 4.6%; pneumonia, 4.5%; and ascites, 3.3%. The available record does not state the group attribution for these term-specific percentages in the information, so they should not be assigned to either arm.
General statistical explanation: participant counts with at least one event differ from counts of event episodes, since one participant may experience more than one event. A meaningful comparison can also depend on exposure time, event definitions, severity, attribution, and the way recurrent events are handled. Those details are not reported in the registry record. The event counts and percentages therefore offer a limited descriptive view rather than a complete comparative safety analysis.
12. What the Result Does, and Does Not, Mean
The registry record establishes the study question, design labels, population definition, endpoint, and selected safety counts. It does not provide a numerical primary survival comparison or its uncertainty in the information available for this account. As a result, the posted information cannot show how large a survival difference was estimated, how precise that estimate was, or whether it was compatible with a range of treatment effects.
The record’s status is terminated. That status should not be read as a result: it does not state why the study ended, whether the endpoint was analyzed as planned, or whether follow-up was complete. Similarly, the presence of a primary endpoint and secondary outcomes describes what was to be assessed, not the findings for those outcomes.
The listed safety counts show that serious and other adverse events were recorded in both groups, and the registry supplies percentages for several serious-event terms. They do not establish causation or provide a complete comparison of risks. Differences in counts cannot be interpreted in isolation from participant exposure, event definitions, follow-up, and analysis methods, which are not fully reported in the available record.
General statistical context: results from a randomized study are interpreted by considering the estimated effect, its uncertainty, the planned analysis, and the population to which the result may apply. A trial’s design can support a comparative question, but it cannot substitute for the numerical results. The registry information supports a careful account of what the study set out to compare and what data fields were posted; it does not support a claim that either treatment strategy did or did not change survival or safety outcomes.
13. Why This Trial Matters Statistically
JANUS 1 illustrates an important distinction in clinical-trial interpretation: a well-defined design and endpoint are not the same as a fully interpretable result. The registry identifies a randomized, double-blind, parallel phase 3 comparison and names overall survival as the primary outcome. Those details clarify the intended question, but the effect estimate and its uncertainty are needed to assess the primary comparison.
The study also highlights why endpoint definitions and analysis populations matter. Overall survival is defined from randomization to death due to any cause, and the intent-to-treat population is specified as all randomized participants. At the same time, the record gives a bounded follow-up description and does not report the detailed time-to-event method, censoring approach, or completeness of follow-up. Such information affects how a survival result should be interpreted.
The secondary outcomes and adverse-event counts show that a trial can address multiple domains, including disease progression, tumor response, and safety. Those outcomes may involve different statistical measures and different sources of uncertainty. Without a stated analysis plan and numerical results, the existence of multiple outcomes also raises unanswered questions about which comparisons were prespecified and how multiplicity was handled.
For researchers and readers, the central statistical lesson is to distinguish registry design information, descriptive counts, and inferential results. Enrollment, group event counts, endpoint definitions, and study status each answer different questions. None alone supplies the estimated treatment effect or its precision. This distinction is especially important when the registry record does not explain termination or provide the primary analysis details.
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 principal limitation for interpreting the primary endpoint is that the registry record does not provide arm-specific death results, an overall-survival estimate, a confidence interval, or a p-value. Without these, the magnitude, direction, and precision of the primary comparison cannot be assessed. The endpoint description refers to deaths through 6 months or the data cutoff 11FEB2016, but the available record does not provide the participant-level follow-up pattern or a detailed analysis method.
The study is marked terminated, while the reason for termination and its analytical consequences are not reported in the registry record. The registry does not explain whether planned follow-up was completed, whether the analysis plan changed, or whether any interim analyses occurred. It also does not report a sample-size justification, allocation ratio, stratification factors, or analysis procedures for the primary endpoint.
Although the intent-to-treat population is defined, the record does not give analysis denominators for the survival outcome, information about missing observations, or the handling of participants with incomplete follow-up. Details about censoring, sensitivity analyses, and subgroup analyses are also not reported. The available adverse-event information provides counts and selected percentages, but does not identify the group attribution of the listed serious-event percentages in this account or fully describe event timing, attribution, exposure, or recurrent events.
Finally, the registry lists multiple outcomes but does not report how multiplicity was managed or how the two recorded analyses relate to the listed outcomes. These omissions do not establish that the analyses were deficient; they limit what can be independently assessed from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1) — NCT02117479.
- Registry record last updated 2019-03-26; status last verified 2019-03.
- Results first posted 2017-07-11.
- 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
NCT02117479, titled Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1), is recorded as a randomized, double-blind, parallel phase 3 study sponsored by Incyte Corporation. It enrolled 321 participants and compared ruxolitinib plus capecitabine with placebo plus capecitabine in advanced or metastatic pancreatic adenocarcinoma after failure of, or intolerance to, first-line chemotherapy.
The primary outcome was overall survival, defined from randomization until death due to any cause and described through 6 months or the data cutoff 11FEB2016. The record lists progression-free survival, response, duration of response, and treatment-emergent adverse events as secondary outcomes. The study is recorded as terminated, with start in 2014-03 and primary completion in 2016-02. Numerical primary survival results and detailed statistical analysis methods are not reported in the registry record.