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 Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas (NCT03504423), a randomized phase 3 study. The primary outcome is Overall Survival (OS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03504423 |
| Phase | Phase 3 |
| Condition | Pancreatic Cancer Metastatic |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 528 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Cornerstone Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
The trial enrolled patients with metastatic adenocarcinoma of the pancreas. The registry describes an eligible age range of 18 to 75 years and records enrollment of 528 participants. The population question is whether results in this trial’s enrolled group can be understood from the posted outcomes; the record does not provide additional participant characteristics in the information.
Intervention
One randomized group received CPI-613 with modified Folfirinox, also called mFolfirinox in the registry. The arm description specifies CPI-613 and components of the modified regimen, but the available description is incomplete. The clinical comparison concerns this combination as a treatment strategy, rather than CPI-613 considered in isolation.
Comparator
The other randomized group received Folfirinox. The registry describes the study as open label, so masking was not used. The trial therefore compares the assigned treatment strategies in parallel groups without masking of participants or study personnel as recorded in the registry.
Primary question
The primary endpoint was overall survival: time from randomization until death from any cause, assessed over a timeframe of 38 months. The central statistical question is how the two groups’ survival outcomes compare and how precisely that comparison is estimated. The registry reports a median and confidence interval for each arm, but no hazard ratio or other sponsor-reported comparative analysis. The arm medians alone do not establish a treatment effect or its statistical significance.
3. Trial Design
This was a randomized, parallel-group, phase III trial with an open-label design. The registry identifies the study as multicenter and reports enrollment of 528 participants. The recorded start date is 2018-11-09, and the primary completion date is 2021-08-16. The study status is completed. These dates describe the registry record; they do not, by themselves, explain recruitment duration or follow-up procedures.
Participants were assigned to CPI-613 with modified Folfirinox or to Folfirinox. The registry lists the primary outcome as overall survival and lists progression-free survival and overall response rate among secondary outcomes. It reports the primary outcome timeframe as 38 months. For the overall-survival outcome, the arm counts are 266.0 for CPI-613 with mFolfirinox and 262.0 for Folfirinox. These are the counts attached to the posted outcome, not a detailed account of every analysis population or every participant’s follow-up status.
Random allocation can help balance prognostic factors across groups on average, while a parallel design compares groups assigned to separate treatment strategies. Neither feature ensures that the groups are identical at baseline or that all sources of bias are removed. Because the trial was open label, treatment assignment was not masked. The registry record does not report further details about allocation concealment, stratification, randomization blocks, adherence, treatment discontinuation, or crossover. Such details should not be inferred from the trial’s phase or randomized designation.
The arm descriptions include specific drug and administration details, but the recorded descriptions are truncated. The complete dosing schedules and any protocol amendments are not reported in the registry record. The entry also does not report the sample-size justification or the prespecified statistical analysis plan. Thus, the study design can be characterized at the level of allocation, arms, endpoints, and recorded dates, but not reconstructed in all protocol detail.
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 | CPI-613, mFolfirinox | Folfirinox |
|---|---|---|
| STARTED | 266 | 262 |
| COMPLETED | 259 | 235 |
| NOT COMPLETED | 7 | 27 |
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 | CPI-613, mFolfirinox | Folfirinox | Total |
|---|---|---|---|---|
| Participants analysed | 266 | 262 | 528 | |
| Age, Customized | years | 61.62 (SD 8.67) | 61.47 (SD 8.30) | 61.55 (SD 8.48) |
| Sex: Female, Male: Female | Participants | 112 | 102 | 214 |
| Sex: Female, Male: Male | Participants | 154 | 160 | 314 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Asian | Participants | 31 | 30 | 61 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 10 | 7 | 17 |
| Race (NIH/OMB): White | Participants | 201 | 200 | 401 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 23 | 24 | 47 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Survival (OS), measured over 38 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
Overall survival is the duration from randomization to death from any cause. It is a time-to-event endpoint: each participant contributes follow-up time until death or, if death has not been recorded during observation, until the participant’s last available follow-up under the analysis rules. The registry defines the endpoint but does not report the detailed rules used to handle censoring or incomplete follow-up.
The reported summary is the median overall survival in each group, with a 95% confidence interval. In general, a median time-to-event value describes the time by which half of the observed group’s survival distribution has reached the event. It gives an interpretable summary of the distribution, but it does not describe the whole survival curve or quantify the relative event rate between groups.
Overall survival is used because it captures time to death from any cause, rather than relying on a judgment about whether a particular event is related to disease progression. A between-group comparison usually needs an estimate and uncertainty measure designed for time-to-event data, such as a hazard ratio or a test of the survival distributions. Those comparative statistics are not reported in the registry record for this primary outcome. The two arm-specific medians and their confidence intervals therefore describe the posted summaries, but do not alone answer the full comparative question.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports median overall survival of 11.1 months for CPI-613 with mFolfirinox, with a 95% confidence interval from 10.22 to 12.94 months. For Folfirinox, it reports a median of 11.73 months, with a 95% confidence interval from 10.12 to 13.24 months. These values are arm-specific summaries of the primary endpoint over the recorded 38-month timeframe.
The registry does not report a hazard ratio, a confidence interval for a between-group effect, or a p-value for overall survival. It also records no sponsor-reported analyses for this outcome. The comparison fields are missing or not estimable for this two-arm median-time endpoint. Consequently, the posted primary results do not quantify the relative hazard of death, nor do they provide a direct test of whether the survival distributions differ. The arm medians should not be treated as if they were a complete comparative analysis.
A confidence interval conveys uncertainty around an estimate under the assumptions of the statistical procedure used. In general, an interval around a median is not the same as an interval around a treatment contrast. Even when arm-specific intervals can be inspected side by side, that inspection does not substitute for an analysis designed to estimate the difference or relative effect. No numerical primary-endpoint comparison should be reconstructed from the two medians alone.
The posted secondary response data include an unadjusted comparison, but that result does not replace the primary overall-survival analysis. Progression-free survival is listed as a secondary outcome, but its result is not reported in the registry record. The absence of a reported comparative overall-survival analysis means that the primary endpoint cannot be interpreted as demonstrating either a favorable or an unfavorable comparative effect. The correct statistical reading is limited to the reported arm-specific medians and their uncertainty.
These results also do not establish that the groups had identical outcomes. A missing comparative estimate is not evidence of no difference; it is a limit on what can be concluded from the recorded analysis. Nor does the numerical ordering of the two medians establish that one treatment strategy is superior. A formal comparison would need an appropriate time-to-event estimate, its uncertainty, and the analysis details used to account for follow-up and censoring.
The enrollment total and the outcome-specific arm counts describe the scale of the study and the numbers attached to the posted summary. They do not provide the number of deaths at each time point or the distribution of follow-up. Those details, along with the methods and population used for the primary analysis, are not reported in the registry record. Interpretation should therefore remain focused on the reported medians and confidence intervals rather than extending them into an unreported treatment-effect conclusion.
9. Statistical Methods Explained
Overall survival is a time-to-event outcome. Unlike a simple count of events, a time-to-event analysis can use information about how long participants were observed and can account for participants whose event time is not observed during follow-up through censoring rules. The registry gives the endpoint definition, timeframe, arm-specific medians, and confidence intervals, but does not report the detailed censoring rules or the method used to calculate the confidence intervals. Those procedures should not be guessed.
What does an arm-specific median describe?
The median is a summary of the time-to-event distribution in one group. It identifies the point at which the estimated distribution reaches its midpoint. It is not an average survival time, and it does not indicate that every participant experienced the event at or near that time. The reported overall-survival medians are 11.1 months for CPI-613 with mFolfirinox and 11.73 months for Folfirinox. Their confidence intervals describe uncertainty around each arm-specific median, not uncertainty around a direct comparison between the arms.
A confidence interval is a range generated by a statistical procedure to express uncertainty in an estimate. In general, its width reflects both the amount of information and the variability of the data, as well as the method used. It should not be interpreted as containing a stated proportion of individual participant survival times. A confidence interval for a single arm’s median also does not answer the same question as a confidence interval for a hazard ratio or a difference in medians.
Why is a comparative time-to-event estimate important?
Time-to-event outcomes are often compared using methods that incorporate event timing and censoring, rather than comparing only the two reported medians. A hazard ratio, when reported, summarizes the relative event rate under the assumptions of the model used; it is not a ratio of the arm medians. Other analyses can compare survival distributions without relying on the same summary. The registry does not report a sponsor hazard ratio, comparative confidence interval, or primary-endpoint p-value, and it lists no reported analyses for this outcome. Therefore, no such result can be described from this record.
The absence of a comparative result matters because a difference in arm-specific point estimates is not itself an inferential test. A formal analysis would ordinarily specify how the outcome was analyzed, which participants were included, and how incomplete follow-up was handled. The registry record does not report those details. The available statistics support description of the two arm-specific results, but not a claim about the magnitude or statistical significance of a between-arm effect.
How should the secondary response comparison be read?
Overall response rate is a binary outcome: participants are classified according to whether they meet the response definition during the specified assessment. The registry reports 104.0 participants with a response among 266.0 in the CPI-613 with mFolfirinox group and 90.0 among 262.0 in the Folfirinox group. The posted unadjusted comparison includes a risk difference and an unadjusted p-value of 0.258. The reported interval for the risk difference extends across the value representing no difference, so it does not provide a clear distinction between a positive and negative contrast at the level of that interval.
A risk difference expresses the difference between two group proportions. A risk ratio compares those proportions as a ratio, while an odds ratio compares the odds of the outcome. Each measure answers a somewhat different question, and an interval around an estimate communicates uncertainty. These are general interpretations of the measures; they do not convert the secondary analysis into a primary-endpoint result. The posted unadjusted comparison does not report an adjustment for testing multiple outcomes or comparisons.
A p-value is a measure of how compatible the observed data are with a specified null model under the analysis assumptions. It is not the probability that the null hypothesis is true, nor does it measure clinical importance. The unadjusted p-value for the response comparison is 0.258. Its interpretation should account for the fact that this is a secondary outcome and that the registry does not report a multiplicity procedure. The number should not be treated as proof that the groups are equivalent.
What do the planning illustrations mean?
The registry includes planning illustrations based on the observed response effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. They are illustrations for future planning, not the trial’s original design calculation and not observed power. For planning for 100% of the observed effect, the figures are 1,618 participants per arm for 80% power and 2,166 per arm for 90% power. For planning for 75% of the observed effect, they are 2,897 participants per arm for 80% power and 3,877 per arm for 90% power. For planning for 50% of the observed effect, they are 6,559 participants per arm for 80% power and 8,781 per arm for 90% power.
In general, smaller target effects require more information to distinguish them from no effect at a fixed significance level and power. These illustrations are conditional on their stated assumptions and on the observed effect used as their reference. They should not be read as evidence about the probability that the completed trial detected an effect, or as a substitute for the trial’s unreported sample-size justification. The registry’s planning assumptions and illustrations do not establish what design choices were made before enrollment.
For any endpoint, analysis choices affect the meaning of estimates and tests. Prespecified methods, population definitions, handling of missing observations, and multiplicity procedures are part of a complete statistical interpretation. Where those details are not recorded, the reported numerical summaries should be described without filling in the missing method from convention or expectation.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when several statistical questions are tested within the same study. If multiple outcomes or contrasts are assessed, interpreting each unadjusted p-value as though it were the only test can overstate the evidence against a null hypothesis. Methods such as a prespecified testing hierarchy or an adjustment to the testing procedure can address this issue, but the registry record does not report whether such a procedure was planned or used. It is not appropriate to assume a particular strategy from the trial’s phase or from the listed endpoints.
The registry lists overall survival as the primary outcome and progression-free survival and overall response rate as secondary outcomes. It provides no result for progression-free survival. The response comparison is unadjusted. The record does not explain whether secondary testing was confirmatory, exploratory, gated by the primary result, or adjusted for multiplicity. Accordingly, the secondary p-value should be interpreted as unadjusted and should not be treated as a study-wide error-controlled conclusion.
Analysis populations are also important. An intention-to-treat analysis, for example, generally retains participants according to randomized assignment, while other analysis populations may use different eligibility or treatment-exposure rules. This is a general distinction; the registry entry does not state the population definition used for each posted result. The arm counts attached to the overall-survival outcome and response outcome do not, on their own, establish the full analysis-population rules.
Missing outcome data and censoring can affect both the amount of information available and the interpretation of estimates. For overall survival, the registry defines the event but does not report the detailed censoring method or the extent and handling of incomplete follow-up. For response, the registry does not report the response-evaluable population rules or how missing assessments were classified. These omissions prevent a full assessment of how missingness may have influenced the endpoint results.
The sample-size justification, interim analyses, prespecified analysis plan, and multiplicity strategy are not reported in the registry record. These are not interchangeable details: a planning calculation describes assumptions about design, an interim analysis concerns analysis before trial completion, and a multiplicity strategy concerns interpretation across tests. Because the record does not document them, none should be inferred. This limits reconstruction of the confirmatory framework and the strength of conclusions intended for each endpoint.
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 |
|---|---|---|---|
| CPI-613, mFolfirinox | 140 | 259 | 54.1% |
| Folfirinox | 133 | 235 | 56.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| CPI-613, mFolfirinox | 140 of 259 |
| Folfirinox | 133 of 235 |
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 |
|---|---|
| CPI-613, mFolfirinox | 258 of 259 |
| Folfirinox | 232 of 235 |
Most frequent serious adverse event terms
| Event term | Organ system | CPI-613, mFolfirinox | Folfirinox |
|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 10 of 259 | 21 of 235 |
| Diarrhoea | Gastrointestinal disorders | 9 of 259 | 18 of 235 |
| Abdominal pain | Gastrointestinal disorders | 15 of 259 | 10 of 235 |
| Leukocytosis | Blood and lymphatic system disorders | 3 of 259 | 17 of 235 |
| Vomiting | Gastrointestinal disorders | 7 of 259 | 8 of 235 |
| Sepsis | Infections and infestations | 10 of 259 | 4 of 235 |
| Nausea | Gastrointestinal disorders | 7 of 259 | 6 of 235 |
| Hypertensive crisis | Vascular disorders | 10 of 259 | 1 of 235 |
| Colitis | Gastrointestinal disorders | 5 of 259 | 5 of 235 |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 5 of 259 | 4 of 235 |
Most frequent non-serious adverse event terms
| Event term | Organ system | CPI-613, mFolfirinox | Folfirinox |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 174 of 259 | 174 of 235 |
| Nausea | Gastrointestinal disorders | 193 of 259 | 155 of 235 |
| Fatigue | General disorders | 153 of 259 | 126 of 235 |
| Anaemia | Blood and lymphatic system disorders | 120 of 259 | 94 of 235 |
| Decreased appetite | Metabolism and nutrition disorders | 111 of 259 | 102 of 235 |
| Vomiting | Gastrointestinal disorders | 107 of 259 | 96 of 235 |
| Neuropathy peripheral | Nervous system disorders | 105 of 259 | 80 of 235 |
| Hypokalaemia | Metabolism and nutrition disorders | 96 of 259 | 87 of 235 |
| Abdominal pain | Gastrointestinal disorders | 90 of 259 | 84 of 235 |
| Weight decreased | Investigations | 87 of 259 | 78 of 235 |
Serious events with the highest arm-level rate: anaemia (8.9%), diarrhoea (7.7%), leukocytosis (7.2%), abdominal pain (5.8%), sepsis (3.9%).
The registry records serious adverse events and other adverse events separately for each treatment group. For CPI-613 with mFolfirinox, 259 participants are listed as at risk for both categories, with 140 affected by serious adverse events and 258 affected by other adverse events. For Folfirinox, 235 are listed as at risk, with 133 affected by serious adverse events and 232 affected by other adverse events. The registry also lists deaths of 140 and 133, respectively. These are counts, not time-adjusted rates.
The serious adverse event terms listed with percentages are anaemia at 8.9%, diarrhoea at 7.7%, leukocytosis at 7.2%, abdominal pain at 5.8%, sepsis at 3.9%, and hypertensive crisis at 3.9%. These entries identify reported terms and percentages; they do not by themselves establish how events were distributed by treatment arm, how long participants were at risk, or whether an event was caused by treatment.
Counts can help describe the recorded safety experience, but comparison requires attention to the number at risk, follow-up time, event definitions, and ascertainment. The registry does not provide all of those details in the information summarized for these outcomes. The figures should therefore be read descriptively, not as proof that one regimen is safer or less safe.
12. What the Result Does, and Does Not, Mean
The primary result gives a descriptive summary of overall survival in each randomized group: a median and confidence interval for CPI-613 with mFolfirinox and a median and confidence interval for Folfirinox. Those estimates describe the recorded outcome, but the registry does not report a comparative hazard ratio, an uncertainty interval for a treatment contrast, or a primary-endpoint test. The primary finding therefore cannot be translated into a quantified comparative effect from the posted statistics.
That limitation is not the same as evidence that the groups had the same outcome. A missing comparison is not a finding of equivalence, and the absence of a reported p-value does not mean the analysis was negative. Equivalence or noninferiority requires a design and analysis suited to those questions, including a prespecified margin; such details are not reported in the registry record. Likewise, the ordering of two medians is not enough to establish that one treatment strategy is better.
The response outcome provides a secondary, unadjusted comparison, but it is not a substitute for the primary survival analysis. Progression-free survival results are not reported in the registry record, so that endpoint cannot help establish whether the pattern across outcomes is coherent. The unadjusted nature of secondary testing and the lack of a reported multiplicity plan further constrain how strongly those results can be interpreted.
General statistical interpretation distinguishes the estimate, its precision, and the assumptions behind the analysis. A point estimate is a summary; an interval conveys uncertainty; and a test addresses compatibility with a specified null model. None of these alone proves causation or determines clinical importance. Randomization strengthens the design for comparing assigned strategies, but the registry record’s limited analysis details still matter for judging the result.
The posted numbers do not establish that either treatment works or does not work. They do not give enough information to infer an individual patient’s likely outcome, and they should not be used as medical advice. Their statistical meaning is narrower: they report arm-specific overall-survival summaries, a selected secondary comparison, and safety counts, while leaving the primary between-group analysis and several methodological details unreported.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of why endpoint summaries and treatment comparisons are not interchangeable. Overall survival is a time-to-event endpoint, yet the registry reports the median in each group without a comparative hazard ratio or test. A reader can describe the arm-specific values and their confidence intervals, but cannot recover a formal comparative conclusion from those summaries alone. The distinction is central to interpreting clinical trial results accurately.
The randomized, parallel-group design and enrollment of 528 participants establish the basic framework for a comparison of two treatment strategies. But design labels do not supply the missing analysis. Knowing that a study is randomized and phase III does not reveal the analysis population, censoring rules, primary comparison method, sample-size justification, or multiplicity plan. These are essential context for understanding how an estimate was obtained and what conclusions it supports.
The record also illustrates how secondary results need to be interpreted in relation to the primary question. An unadjusted response comparison cannot substitute for a missing primary survival comparison, and a named secondary outcome without posted results cannot be treated as corroboration. Where multiple endpoints are considered, the confirmatory status of each result and the approach to multiplicity affect the weight that should be placed on nominal findings.
Finally, safety counts require context about denominators, follow-up, definitions, and attribution. The registry provides counts and selected adverse-event terms, but those alone do not yield a complete comparative safety analysis. Together, these features show why sound statistical reading depends not only on the reported numbers but also on the design and analysis information accompanying them. The record supports careful description, while leaving important comparative and methodological questions unanswered.
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.
A central limitation is the absence of a reported comparative analysis for the primary overall-survival endpoint. The registry provides a median and confidence interval for each arm, but no hazard ratio, comparative interval, or p-value. As a result, the primary endpoint cannot be summarized as a quantified treatment contrast or interpreted through a reported primary hypothesis test.
Several analysis details that would help assess the estimates are not reported in the registry record. These include the primary analysis population, censoring and missing-data rules, the statistical method, interim analyses, and the sample-size justification. The registry also does not report whether randomization used stratification or how allocation was concealed. Their absence from the record does not establish that the procedures were absent from the trial; it means they cannot be characterized from this entry.
The secondary evidence is incomplete. Progression-free survival is listed but its result is not reported. The available response comparison is unadjusted, and a multiplicity plan is not reported. This makes the response result less suitable as a stand-alone confirmatory finding and prevents assessment of the full secondary-outcome pattern.
The safety summaries are counts, and the record does not provide the full context needed to compare event rates over time or attribute events to treatment. The serious adverse event terms and percentages are also not tied to an arm in the information. In addition, the available arm descriptions are truncated, limiting detailed characterization of the regimens from this entry alone.
These are limitations of what can be interpreted from the registry record, not proof that relevant procedures or information were absent from the trial’s protocol or other records. Conclusions should remain restricted to the outcomes and analysis details actually recorded.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas — NCT03504423.
- Registry record last updated 2023-01-03; status last verified 2021-09.
- Results first posted 2023-01-03.
- 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
NCT03504423 is a completed, randomized, open-label, multicenter phase III trial comparing CPI-613 with modified Folfirinox against Folfirinox in metastatic adenocarcinoma of the pancreas. The registry reports enrollment of 528 participants, a start date of 2018-11-09, and primary completion on 2021-08-16.
The primary endpoint is overall survival, defined as time from randomization to death from any cause, with a timeframe of 38 months. Arm-specific medians and confidence intervals are reported, but no sponsor-reported comparative hazard ratio or primary-endpoint test is present. Overall response rate is reported as a secondary outcome with an unadjusted comparison; progression-free survival is listed but its result is not reported in the registry record. Safety information includes serious and other adverse-event counts and selected serious-event terms.
The record supports description of these posted summaries, but does not provide enough comparative or methodological detail to reconstruct the primary treatment-effect analysis or the full confirmatory plan.