A Vaccine (CDX-1401) With or Without a Biologic Drug (CDX-301) for the Treatment of Patients With Stage IIB-IV Melanoma: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Vaccine (CDX-1401) With or Without a Biologic Drug (CDX-301) for the Treatment of Patients With Stage IIB-IV Melanoma (NCT02129075), a randomized phase 2 study. The primary outcome is Immune T-cell Response to NY-ESO-1.

2. Clinical Question

The study addresses whether adding CDX-301 is associated with a different measured immune response when CDX-1401 and poly-ICLC are also administered. The registry describes CDX-1401 as a vaccine directed at NY-ESO-1 and describes CDX-301 as a biologic drug that may increase dendritic cells. These descriptions provide the biological rationale for measuring an immune response; they do not establish that a measured response translates into a clinical benefit.

The primary endpoint is an immune assay outcome, not tumor recurrence or survival. Those outcomes appear among the secondary outcomes, but the posted record does not include analyses for them. The study therefore chiefly informs the recorded immune-response comparison, and the endpoint should be interpreted on that basis.

3. Trial Design

The registry classifies this as a phase II, randomized, open-label, multicenter study with a parallel-group design. Participants were assigned to one of two treatment arms. Masking was listed as none, so the trial was open-label. The sponsor was the National Cancer Institute.

Arm I received CDX-301, CDX-1401, and poly-ICLC. The schedule describes CDX-301 injections around the first cycle and during days 1-3 of the second cycle. CDX-1401 was given on day 1 of each cycle, and poly-ICLC on days 1-2 of each cycle. Arm II received CDX-1401 and poly-ICLC without CDX-301. The record describes treatment repeating every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity. The Arm I schedule description ends before completing its final sentence, so the record does not report the full corresponding stopping-condition wording for that arm.

The registry lists planned enrollment as 60. The primary endpoint listings use denominators of 28 in Arm I and 26 in Arm II; the secondary immune-response listing uses 30 and 28. These endpoint-specific denominators are not identical, and the registry record does not report why. The adverse-event record lists 30 participants at risk in each arm. These are different reported measures and should not be combined into a newly calculated participant total.

The start date is 2014-04-09, primary completion is listed as 2016-03-28, and study status is completed. The record does not report the original sample-size justification, the detailed allocation procedure, or further information about the participating centers.

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: No enrolled participants were excluded from the study before assignment to groups.

Overall 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.

6. Primary Endpoint

The registry lists the primary outcome as Immune T-cell Response to NY-ESO-1, measured over At 12 weeks after final vaccination.

The primary endpoint is the count of participants with an immune T-cell response to NY-ESO-1, assessed at 12 weeks after final vaccination. The registry says response rates were to be presented for each assay, antigen, treatment arm, and assessed time point, with corresponding 95% confidence intervals calculated using the score test method. The endpoint is therefore a binary participant-level outcome: a participant is counted according to whether the assay indicates a positive response.

Measuring an immune response is relevant to the stated biological rationale: CDX-1401 targets NY-ESO-1, and CDX-301 is intended to affect dendritic-cell availability. The outcome can describe whether the recorded immune response differs between treatment arms. It does not directly measure tumor control, recurrence, or survival, and it cannot by itself establish whether any immune response changes those clinical outcomes.

The registry also describes a comparison of the cohorts at the peak time point using Fisher's exact test, with a one-sided significance threshold of 0.10. The endpoint listing does not give assay-level response definitions, the number of assessments contributing to the primary result, or additional details about how peak time was selected. Those details are not reported in the registry record.

7. Results Posted in the Registry

• Arm II (CDX-1401 and Poly-ICLC): 38.5% (10/26) versus 53.6% (15/28) on control; risk difference -15.1 percentage points (95% CI -41.4 to 11.2), risk ratio 0.72 (0.40–1.30); unadjusted two-proportion z-test p = 0.266.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

T Cell Responses to Other Ongoing and Nascent Antitumor Response Antigens Associated With Melanoma (e.g. PRAME, MAGE-A3, p53, and gp1000) as Well as Memory and Chronic Viral Responses (CMV, EBV)

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Arm II (CDX-1401 and Poly-ICLC): 25.0% (7/28) versus 23.3% (7/30) on control; risk difference 1.7 percentage points (95% CI -20.4 to 23.7), risk ratio 1.07 (0.43–2.67); unadjusted two-proportion z-test p = 0.882.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Arm II (CDX-1401 and Poly-ICLC) and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes broaden the study beyond the primary NY-ESO-1 immune-response question. They include T-cell responses to other antigens and memory or chronic viral responses, changes in peripheral blood cell subsets, tumor recurrence, and overall survival. The posted outcome information is uneven: an additional immune-response comparison has counts and a comparative summary, while the registry does not post analyses for the other listed outcomes.

The available secondary immune-response comparison does not add a clear, precise between-arm contrast to the primary result. Its uncertainty is broad, and its unadjusted p-value is 0.882. It is best regarded as contextual evidence about the wider immune-response measurements, not as an independent confirmation of the primary finding or as a clinical outcome result.

Secondary outcomes generally carry less weight than a prespecified primary endpoint because they may be exploratory, may involve multiple comparisons, and may be measured in smaller or different analysis populations. In this registry, the number of posted analyses is zero, and the record does not report a multiplicity plan. The possibility of many assays, antigens, time points, or outcome measures makes isolated secondary comparisons especially difficult to interpret without a clearly stated testing strategy.

The secondary listings also have different denominators and time frames. For the additional T-cell response outcome, the stated time frame is up to 12 weeks after final vaccination, whereas the primary outcome is specified at 12 weeks after final vaccination. The registry does not explain the denominator differences or describe how missing measurements were handled. The secondary findings therefore add limited context and cannot settle the primary uncertainty or support conclusions about recurrence or survival.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• T Cell Responses to Other Ongoing and Nascent Antitumor Response Antigens Associated With Melanoma (e.g. PRAME, MAGE-A3, p53, and gp1000) as Well as Memory and Chronic Viral Responses (CMV, EBV)
• Frequency and Phenotypic Character of PBMC Subsets Including DCs, Monocyte Populations, T Cells, and NK Cells - Highest Peak Fold Change Over Baseline (Log 2 Fold)
• Tumor Recurrence
• Overall Survival

9. Statistical Interpretation

10. Statistical Methods Explained

For a binary endpoint, the response proportion is the number of participants recorded with a positive response divided by the endpoint denominator for that arm. A risk difference compares those proportions by subtraction. Its sign depends on the comparison order: the posted comparison is Arm II relative to Arm I, so a negative estimate indicates a lower estimated response proportion for Arm II. This is a description of the statistical measure, not a statement about treatment benefit.

What does a risk difference describe?

A risk difference is expressed on the probability scale and gives an absolute contrast between two response proportions. It is different from a risk ratio, which compares proportions multiplicatively, and an odds ratio, which compares odds. The posted comparison includes all three types of estimates. Because the endpoint is a participant count, each measure summarizes the observed positive-response outcomes in the two arms; none conveys the reasons for a response or its clinical importance.

The primary comparison lists a risk difference, a risk ratio, and an odds ratio, along with confidence limits and an unadjusted p-value. The secondary immune-response comparison has the same types of summary. The risk-difference interval is particularly useful for seeing the range of absolute between-arm contrasts compatible with the data under the method used. In both comparisons, the interval includes no difference. The interval should be considered alongside the estimate rather than reduced to a significant-or-not label.

Why use a confidence interval?

In general, a confidence interval expresses uncertainty in an estimate: it identifies a range of values compatible with the observed data under the method's assumptions. It does not give the probability that the true effect lies inside the particular interval, and it does not account automatically for every source of uncertainty, such as missing outcome data or selective reporting. The registry says that response rates were to have 95% confidence intervals calculated using the score test method. The comparative summaries also display confidence limits, but the posted record does not give a full description of the calculation used for each comparative interval.

For the planned primary test, the registry describes Fisher's exact test to compare the cohorts at the peak time point. This test is used for categorical outcomes in small samples and evaluates how compatible the observed allocation of positive responses is with the null hypothesis of no association, conditional on the margins. The registry states a one-sided p-value threshold of 0.10. A one-sided test assesses evidence in a specified direction; the registry record does not state the directional hypothesis in further detail. The displayed unadjusted p-value should not be assumed to be the same analysis as that planned test unless the record confirms the calculation and direction.

What does an unadjusted p-value tell the reader?

In general, a p-value describes how unusual the observed data, or data more extreme, would be under a specified null model and test. It is not the probability that the null hypothesis is true, nor is it a measure of the size or clinical importance of an effect. The posted primary comparison gives an unadjusted p-value of 0.266, and the secondary comparison gives an unadjusted p-value of 0.882. Those values should be interpreted with the estimates and intervals, and with caution because the record does not report a multiplicity adjustment or full analysis specification.

The primary outcome description discusses positive-response frequencies by assay, antigen, arm, and time point, and a comparison at peak time. That structure can involve multiple measurements. The record does not say how the peak time was selected or whether the displayed comparison accounts for the set of possible assays and time points. Such choices matter because repeated testing can increase the chance of a seemingly notable result arising by chance. No correction or other multiplicity strategy is reported in the registry record.

Why do denominators differ?

The endpoint denominators differ across the posted primary and secondary immune-response results, and the adverse-event risk sets are reported separately. In general, endpoint denominators can differ when outcome availability or analysis eligibility differs, but the reason in this trial is not reported in the registry record. The record also does not describe how missing assays were handled, whether participants were analyzed according to randomized assignment, or which population was intended for each analysis. It would be inappropriate to infer those procedures from the counts alone.

There are no reported analyses in the outcome-analysis listings. Thus, the registry supplies outcome counts and comparative summaries, while important implementation details remain unavailable. The statistical interpretation should be limited to the posted summaries and should not imply that the full planned analysis, missing-data approach, or analysis population can be reconstructed from them.

11. Confidence Intervals and Precision

The primary comparison is uncertain: its confidence interval for the risk difference extends across zero, meaning the posted data are compatible with a lower response proportion in Arm II, little or no difference, or a higher response proportion. The displayed estimate points toward a lower proportion in Arm II, but the interval does not pin down the size or even the direction of the underlying difference with precision. The unadjusted p-value is 0.266.

The endpoint counts are 15 of 28 in Arm I and 10 of 26 in Arm II. Those denominators are modest, so each participant's outcome has a meaningful influence on the observed proportion. The confidence interval communicates this sampling uncertainty, but it does not cover uncertainty from possible missing assessments, assay variation, or choices among measurement times and tests. The record does not report enough detail to quantify those additional sources.

The secondary immune-response comparison is also imprecise. Its risk-difference interval extends on both sides of no difference, and the unadjusted p-value is 0.882. The interval does not establish that the arms are alike; rather, it indicates that the data do not narrowly identify the magnitude or direction of a between-arm difference.

Confidence intervals are more informative when read as ranges of plausible effects under the statistical method, rather than as a pass/fail boundary. Here, the breadth of the intervals and the limited endpoint denominators argue against strong claims about the size of an immune-response contrast. The registry record does not report a prespecified precision target or the original design assumptions that would help judge the intended certainty.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size figures are planning illustrations derived from the observed effect, not the trial's original design calculation. They are expressed as participants per arm, not as total participants or total events. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect used in each row is the stated fraction of the observed effect. The original sample-size assumptions are not reported in the registry record.

For the primary immune-response comparison, planning for 100% of the observed effect gives 170 participants per arm for 80% power and 227 participants per arm for 90% power. Planning for 75% of the observed effect gives 304 participants per arm for 80% power and 407 participants per arm for 90% power. Planning for 50% of the observed effect gives 687 participants per arm for 80% power and 919 participants per arm for 90% power.

In plain language, the 80% power column represents a planning target for the chance of detecting the specified effect under the stated assumptions if that effect is present. The 90% column uses a higher target chance of detection. These are design illustrations, not observed power. A smaller target effect requires more participants per arm because it is harder to distinguish from random variation.

The secondary immune-response planning figures are much larger: 10,356 and 13,863 participants per arm for 100% of the observed effect, 18,302 and 24,501 for 75%, and 40,935 and 54,800 for 50%, with the lower and higher figures in each pair corresponding to the 80% and 90% power targets. These values reflect the small observed secondary contrast used in the illustration; they should not be read as the trial's enrollment plan or as evidence that the study had a particular probability of success.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.536; treatment proportion p₁ = 0.385; average p̄ = 0.460.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.7049 = 1.3815.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6967 = 0.5864.
4. n = (1.3815 + 0.5864)² / (-0.1511)² = 169.6, rounded up to 170 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.535714285714286                          # control proportion
p1 <- 0.384615384615385                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(2129075)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 170 (80% power), 227 (90% power)
 75% of observed effect: n per arm = 304 (80% power), 407 (90% power)
 50% of observed effect: n per arm = 687 (80% power), 919 (90% power)
power.prop.test: 169.6 
Simulated power at n = 170 per arm: 0.801 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry describes several immune-response assessments by assay, antigen, arm, and time point, including a comparison at the peak time point. It also lists secondary outcomes covering immune-cell subsets, tumor recurrence, and overall survival. With multiple measurements, repeated testing can increase the chance of a statistically notable result appearing by chance. The registry record does not report a multiplicity adjustment, a hierarchy for testing outcomes, or a plan for controlling the overall false-positive rate.

The primary endpoint description gives a 95% confidence-interval method and names Fisher's exact test for a cohort comparison at peak time, with a one-sided threshold of 0.10. This is not a complete account of all analysis decisions. The registry does not report how peak time was selected, whether there was a single assay definition for a positive response, or how the multiple antigens and time points were handled in the inferential plan. The outcome-analysis listings report no analyses.

Missing-data procedures are not reported in the registry record. The primary outcome denominators are 28 and 26, while the secondary immune-response denominators are 30 and 28. The adverse-event risk sets are 30 in each arm. These endpoint-specific counts do not establish why outcomes were unavailable or whether participants were excluded for other reasons. No imputation, sensitivity analysis, or missingness assumption is described.

The analysis population is also not reported in detail. The registry does not state whether the immune-response comparisons include all randomized participants, only participants with an evaluable assay, or another defined population. It is therefore not possible to determine from the posted results whether the estimates preserve the randomized comparison or how departures from the assigned treatment were handled. These omissions limit reproducibility and make the results harder to compare with a fully specified analysis report.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: general disorders and administration site conditions (3.3%), infections and infestations (3.3%), nervous system disorders (3.3%), pregnancy, puerperium and perinatal conditions (3.3%).

The adverse-event record lists 30 participants at risk for serious adverse events in each arm. It records 0 participants affected in Arm I and 4 in Arm II. These are counts of participants with a serious adverse event, not counts of all serious-event episodes. The record also lists 30 participants at risk for other adverse events and 30 affected in each arm.

The serious-event terms listed with the highest reported frequencies are general disorders and administration site conditions, infections and infestations, nervous system disorders, and pregnancy, puerperium and perinatal conditions; each is listed as 3.3%. The record does not provide additional detail about severity grades, event timing, relationship to treatment, or whether an individual participant could contribute to more than one term. Deaths are not reported in the registry record.

These safety figures are descriptive. The counts should be interpreted in light of the recorded risk sets and the limited information on event definitions and follow-up. They do not, by themselves, establish a causal treatment difference.

16. What the Result Does, and Does Not, Mean

The posted primary result describes immune T-cell responses to NY-ESO-1 at 12 weeks after final vaccination. The response counts are 15 in Arm I and 10 in Arm II, with endpoint denominators of 28 and 26. The comparative estimate is in the direction of a lower response proportion in Arm II, but its confidence interval spans no difference and the unadjusted p-value is 0.266. The data therefore leave substantial uncertainty about the size and direction of the between-arm contrast.

This finding is about an immune assay outcome. It does not establish that CDX-301 changes tumor recurrence, overall survival, or any other clinical outcome. Those outcomes are listed in the registry, but their analyses are not posted. Nor does a response count by itself show that a measured immune response is clinically meaningful or durable.

The result also does not show that the arms are equivalent. A nonsignificant comparison and an interval spanning no difference do not demonstrate equivalence; a formal equivalence or noninferiority question requires a prespecified margin and an appropriate design and analysis. Such a margin is not reported in the registry record.

Because the study was open-label and the endpoint denominators are limited, the result should be read as an uncertain comparative estimate rather than a definitive answer about the treatment regimens. The record does not report assay-level response criteria, missing-data handling, or a detailed analysis population. Those gaps constrain assessment of how the reported counts were assembled. The most supportable interpretation is limited to the immune-response summaries and their uncertainty.

17. Why This Trial Matters Statistically

This trial illustrates the distinction between a biological measurement and a clinical outcome. The primary endpoint counts participants with a T-cell response to NY-ESO-1, a measure connected to the study's vaccine rationale. Such an endpoint can be useful for describing immune activity, but it does not substitute for outcomes such as tumor recurrence or survival. Keeping that distinction clear prevents an immune-response result from being overstated as evidence about clinical benefit.

It also illustrates why a point estimate should not be interpreted alone. The primary comparative estimate points in one direction, but the confidence interval spans no difference and the unadjusted p-value is 0.266. The secondary immune-response comparison is similarly uncertain. These features show how a study can produce numerical contrasts without providing a precise answer about the underlying effect.

The record is also a useful example of why denominator and analysis details matter. Primary and secondary outcome denominators differ, the record does not explain the differences, and analysis populations and missing-data procedures are not reported. The endpoint listings contain no reported analyses. Without this information, a reader cannot fully reconstruct how outcome eligibility, assay availability, or analysis choices affected the estimates.

Finally, the planning illustrations show how sample-size requirements depend on the effect chosen for planning. Smaller effects require more participants per arm under the stated assumptions. Because these illustrations use observed effects and do not reproduce the trial's original design calculation, they should inform general planning interpretation rather than be treated as a retrospective judgment of the trial's design.

18. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The registry record leaves several trial-specific uncertainties. The primary outcome is an assay-based immune response, but the record does not report the criteria defining a positive response or describe the assay procedures in sufficient detail to assess measurement reliability. It also does not explain how the peak time point was selected, despite describing a comparison at that time.

Endpoint denominators differ across the primary and secondary immune-response outcomes, and the record does not explain the differences. Missing-data handling, analysis populations, and treatment of participants who did not complete the planned regimen are not reported. These omissions make it difficult to judge the extent to which the displayed comparisons reflect all randomized participants or only participants with available measurements.

The study was open-label, and masking was listed as none. The record does not describe whether laboratory assessment was blinded to treatment assignment. The registry does not report a multiplicity strategy despite describing assessments across assays, antigens, and time points. These gaps limit interpretation of the inferential results and make the analysis difficult to reproduce.

The registry lists tumor recurrence and overall survival as secondary outcomes but does not post analyses for them. The posted immune-response results therefore cannot answer those clinical questions. The record also does not provide a full statistical analysis report, the original sample-size justification, or further detail on allocation procedures. These limitations are specific to what the registry record reports and do not establish that the omitted procedures were not conducted.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: A Vaccine (CDX-1401) With or Without a Biologic Drug (CDX-301) for the Treatment of Patients With Stage IIB-IV Melanoma — NCT02129075.
• Registry record last updated 2021-11-16; status last verified 2021-11.
• Results first posted 2021-11-16.
• 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.

22. Record Summary

NCT02129075 is a completed phase II, randomized, open-label, multicenter, parallel-group study sponsored by the National Cancer Institute. It compared CDX-301, CDX-1401, and poly-ICLC with CDX-1401 and poly-ICLC in patients with stage IIB-IV melanoma. Planned enrollment was 60.

The primary outcome was the count of participants with an immune T-cell response to NY-ESO-1 at 12 weeks after final vaccination. The posted counts were 15 of 28 in Arm I and 10 of 26 in Arm II. The comparative interval spans no difference, and the unadjusted p-value is 0.266. Secondary outcome analyses for recurrence, survival, and other listed measures are not reported in the registry record.

The record lists serious adverse events in 0 participants in Arm I and 4 in Arm II, with 30 participants at risk in each arm. Key analysis details, including missing-data handling, analysis populations, and multiplicity procedures, are not reported in the registry record.