The Study of Oral Steroid Sulphatase Inhibitor BN83495 Versus Megestrol Acetate (MA) in Women With Advanced or Recurrent Endometrial Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Study of Oral Steroid Sulphatase Inhibitor BN83495 Versus Megestrol Acetate (MA) in Women With Advanced or Recurrent Endometrial Cancer (NCT00910091), a randomized phase 2 study. The primary outcome is Percentage of Women With Advanced or Recurrent Endometrial Cancer Who Have Neither Progressed Nor Died.

2. Clinical Question

3. Trial Design

This was a phase II, international, multicentre, randomized, open-label study with a parallel-group design. The registry lists enrollment as 73 and the status as completed. The recorded study start is 2009-08, with primary completion in 2012-01. These registry entries describe the study record and do not explain how the planned enrollment was chosen.

Participants were assigned to BN83495 40 mg or MA 160 mg. The arm descriptions state that randomization followed confirmation of eligibility and that an Interactive Voice Response System allocated the randomization number and associated treatment. Because masking was listed as none, participants and investigators were not blinded to assigned treatment according to the registry design description.

The primary endpoint was the percentage of subjects with neither progression nor death up to 6 months. Its assessment relied on investigator assessment and RECIST, not central review. The registry defines the six-month timepoint as the treatment start date plus 183 days (26 weeks). The primary analysis population is described as intent-to-treat, with inclusion limited to randomized subjects who received at least one dose.

The posted primary outcome includes 36.0 participants in the BN83495 arm and 37.0 in the MA arm. Arm-specific percentages and 90% confidence intervals are reported. The registry also lists secondary outcomes concerning adverse events, treatment exposure and tolerability, quality of life in participants over 65 years, clinical benefit, overall response, and objective tumour progression. The record does not report the original sample-size justification or the full statistical analysis plan.

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.

Pre-assignment

Reasons for not completing this period:

Treatment and Survival

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Intent-to-treat (ITT) population includes all randomized subjects who received at least one dose of study medication.

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 Percentage of Women With Advanced or Recurrent Endometrial Cancer Who Have Neither Progressed Nor Died, measured over Up to 6 months.

The primary outcome is the percentage of women with advanced or recurrent endometrial cancer who had neither progressed nor died by up to 6 months. It is a fixed-time summary of progression-free status: a participant counts as having the outcome if neither of those events had occurred by the defined assessment time. The registry specifies the timepoint as treatment start plus 183 days (26 weeks).

Progression was assessed by investigators using RECIST, rather than by central review. The registry’s endpoint population is the intent-to-treat population, defined as all randomized subjects who received at least one dose of study medication. This definition matters when reading the result: it is not described as an analysis of every randomized subject regardless of treatment receipt.

A percentage at a specified timepoint offers a direct description of the proportion meeting the endpoint in each group. It does not, on its own, describe the timing of progression or death throughout follow-up, nor does it convey the full course of participants’ outcomes. The posted percentage should therefore be read alongside its confidence interval, which indicates the uncertainty around the group estimate. The open-label design and investigator assessment are relevant context when interpreting an outcome that includes an investigator-assessed progression event.

7. Results Posted in the Registry

• Arm B: MA 160 mg: 54.1% (20/37) versus 36.1% (13/36) on control; risk difference 17.9 percentage points (95% CI -4.5 to 40.4), risk ratio 1.50 (0.88–2.53); unadjusted two-proportion z-test p = 0.124.

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.

Percentage of Participants With Clinical Benefit [Including Completed Response (CR), Partial Response (PR), and Stable Disease (SD)] ≥12 Weeks

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Arm B: MA 160 mg: mean 19.00 versus 13.00 on control; difference 6.00 (95% CI -14.33 to 26.33), standardized effect d = 0.13; z-test p = 0.563.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Arm B: MA 160 mg and the control. The interval gives the range of effects that remain compatible with the data.

Percentage of Participants With Overall Response (OR) Including CR and PR

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Arm B: MA 160 mg: mean 11.00 versus 3.00 on control; difference 8.00 (95% CI -1.95 to 17.95), standardized effect d = 0.36; z-test p = 0.115.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Arm B: MA 160 mg and the control. The interval gives the range of effects that remain compatible with the data.

Percentage of Participants With First Documentation of Objective Tumour Progression From Randomisation

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Arm B: MA 160 mg: mean 24.00 versus 30.00 on control; difference -6.00 (95% CI -40.32 to 28.32), standardized effect d = -0.08; z-test p = 0.732.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Arm B: MA 160 mg and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes broaden the description beyond the primary six-month status. They cover clinical benefit, overall response, objective tumour progression, adverse events, tolerability and exposure, and a quality-of-life outcome for participants over 65 years. This range can help characterize what was recorded during the study, but these outcomes do not replace the primary question of whether participants had progressed or died by up to 6 months.

The posted secondary results do not form one uniform set of analyses. The registry reports percentage summaries for outcomes extending up to 2 years, and it also lists Kaplan-Meier analyses for clinical benefit and overall response. Those methods summarize data differently, so results should be interpreted according to the measure and analysis attached to each outcome. The registry does not report enough detail to establish that all secondary analyses used a common estimand or analysis population.

Secondary outcomes are generally less conclusive when many are examined without a reported adjustment for multiplicity. Multiplicity means that evaluating multiple outcomes increases the chance of at least one apparently notable finding arising by chance, even if each test is considered separately. The registry record does not report whether multiplicity was addressed. Accordingly, individual secondary p-values should be treated as exploratory context rather than as independent confirmation of the primary finding.

The secondary outcomes also differ in clinical meaning and measurement. A response measure, a clinical-benefit measure, a progression measure, and a tolerability measure do not answer the same question. Their pattern can help describe the trial, but it cannot be combined into a single overall conclusion without an analysis plan and rationale that are not reported in the registry record. The primary result remains the main basis for interpreting the stated primary question, with the secondary findings supplying context and avenues for further study.

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

• Percentage of Participants With Adverse Event (AE)
• Tolerability of BN83495 Based on Length of Exposure
• Tolerability of BN83495 Based on Cumulative Dose Administered
• Tolerability of BN83495 Based on Dose Interruptions and Reason for Interruptions
• Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score
• Percentage of Participants With Clinical Benefit [Including Completed Response (CR), Partial Response (PR), and Stable Disease (SD)] ≥12 Weeks
• Percentage of Participants With Overall Response (OR) Including CR and PR
• Percentage of Participants With First Documentation of Objective Tumour Progression From Randomisation

9. Statistical Interpretation

10. Statistical Methods Explained

The endpoint is expressed as a percentage, so the primary summaries describe the proportion of participants in each arm who met the specified status by up to 6 months. The registry gives arm sizes, percentages, and 90% confidence intervals. It also posts an unadjusted comparison of MA with BN83495. The registry record does not identify the exact method used to calculate the primary confidence intervals or the comparison p-value.

What does a confidence interval describe?

In general, a confidence interval communicates the uncertainty associated with an estimate under the statistical method used. A narrower interval indicates greater precision, while a wider interval indicates less precision. It is not a range that contains a known true value with certainty, and it does not show the range of individual participant outcomes. For this trial, the primary arm intervals are 24.3% to 49.8% and 40.8% to 66.8%. Their width is a reminder that the arm percentages are estimates rather than exact population values.

How should the group comparison be read?

The posted unadjusted comparison addresses the difference between the two groups. Its p-value is 0.124. A p-value measures how compatible the observed data are with a specified no-difference model under the assumptions of the test; it is not the probability that a treatment is effective or ineffective. The registry does not report the exact test used for this primary comparison. Nor does a p-value alone communicate the size or precision of an effect, so it is interpreted alongside the arm estimates and intervals.

General statistical context: an unadjusted comparison does not account for other variables unless those adjustments are explicitly part of the analysis. The registry record does not report an adjusted primary analysis. The unadjusted value therefore describes the posted comparison as stated, not a covariate-adjusted estimate.

What do the secondary summaries represent?

Some secondary outcomes are also reported as percentages of participants, while the record labels their parameter as a mean and gives a standard deviation. For clinical benefit, the arm summaries are 13.0% and 19.0%, with standard deviations of 36.1 and 51.4. For overall response, the summaries are 3.0% and 11.0%, with standard deviations of 8.3 and 29.7. These summaries describe the registry’s posted results; they should not be confused with the primary fixed-time endpoint.

For these outcomes, the record also includes unadjusted mean-difference calculations and separate reported Kaplan-Meier analyses. Those are different analytical summaries. A mean difference calculated from the posted arm summaries is not automatically the same estimand as a Kaplan-Meier analysis, and their p-values need not match. The registry does not provide enough detail to reconstruct the Kaplan-Meier analyses or explain the relationship between every reported analysis and the descriptive percentage outcomes.

General statistical context: standard deviation describes variation in observations, whereas a confidence interval describes uncertainty in an estimated quantity. They answer different questions. When percentages vary widely across participants, a mean and standard deviation may be difficult to interpret as a simple binary event summary; the registry’s labels and outcome definition should therefore be considered together.

Why can variation affect an analysis?

General explanation: over-dispersion occurs when outcome variation is greater than a model assumes. If a model understates variability, its standard errors may be too small and its intervals or tests may appear more certain than warranted. The record does not report that over-dispersion was assessed or that a model accounting for it was used, so it cannot be assumed to have formed part of this trial’s analysis.

The registry lists five reported analyses and twelve outcome measures, with eleven secondary outcomes posted. It does not report whether the primary analysis was adjusted for multiple comparisons, how missing endpoint data were handled, whether interim analyses occurred, or which other statistical methods were prespecified. These omissions limit how fully the analysis can be evaluated from the registry record alone.

11. Confidence Intervals and Precision

The primary arm estimates are 36.1% for BN83495 and 54.1% for MA. Their 90% confidence intervals are 24.3% to 49.8% and 40.8% to 66.8%, respectively. Each interval spans a meaningful range of possible underlying group percentages, so the observed estimates should not be read as precise measurements of what would occur in a broader population.

Confidence intervals convey sampling uncertainty under the method used to construct them. They do not account automatically for every source of uncertainty, such as outcome assessment choices, missing data, or limitations in study design. The primary progression assessment was investigator-based, not centrally reviewed, and the study was open label. The registry does not quantify how these features affect precision or potential bias.

The unadjusted primary p-value is 0.124, but a p-value is not a substitute for interval estimates. The registry does not report a confidence interval for the primary between-group comparison in the posted outcome fields, and the method for that comparison is not specified. Consequently, the arm-specific intervals should not be mistaken for an interval around the difference between arms.

The recorded enrollment is 73, and the primary outcome includes 36.0 and 37.0 participants in the respective arms. Those sample sizes provide context for the uncertainty but do not establish whether the study met its original design target, which is not reported in the registry record. The available estimates support a cautious description of the observed groups, rather than a highly precise conclusion about the difference between treatments.

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 planning figures are illustrations based on observed effects, not the trial’s original design calculation. For the primary comparison and the other non-time-to-event comparisons, the figures are participants per arm. When a planning figure is stated for 80% power, it means the number of participants per arm that the illustration estimates would be needed for an 80% chance of detecting the assumed effect under its specified conditions. The 90% power column describes the corresponding planning target for a higher chance of detection.

The listed assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is the stated fraction of the observed effect. The primary planning figures are 120 participants per arm for 80% power and 160 participants per arm for 90% power when planning for 100% of the observed effect. For 75% of the observed effect, they are 212 and 283 participants per arm; for 50% of the observed effect, they are 470 and 628 participants per arm.

Smaller effects require more participants to detect under the same assumptions. These figures are sensitive to the observed effect used as their starting point, so they should not be read as a recommendation or as evidence that the completed study had a particular probability of finding a result. They are not observed power. The original trial sample-size justification and design assumptions are not reported in the registry record.

For a time-to-event planning calculation, the record says figures are total events rather than participants per arm. The primary endpoint planning illustration is a percentage comparison, so its figures are participants per arm.

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 = 0.361; treatment proportion p₁ = 0.541; average p̄ = 0.451.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.7037 = 1.3792.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6921 = 0.5825.
4. n = (1.3792 + 0.5825)² / (0.1794)² = 119.5, rounded up to 120 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 <- 0.361111111111111                          # control proportion
p1 <- 0.540540540540541                          # 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(910091)
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 = 120 (80% power), 160 (90% power)
 75% of observed effect: n per arm = 212 (80% power), 283 (90% power)
 50% of observed effect: n per arm = 470 (80% power), 628 (90% power)
power.prop.test: 119.5 
Simulated power at n = 120 per arm: 0.796 (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 lists twelve outcome measures, including the primary endpoint and eleven posted secondary outcomes, and five reported analyses. It does not report a multiplicity adjustment or explain how the primary and secondary outcomes were prioritized for statistical testing. When several outcomes are tested, the chance of an apparently notable result can increase. Without a reported strategy, individual secondary p-values should be viewed cautiously and should not be treated as though each were the sole planned test.

The analysis population for the primary outcome is described as intent-to-treat, including randomized subjects who received at least one dose of study medication. This definition is narrower than a definition that includes all randomized subjects irrespective of treatment receipt. The registry does not state whether other analysis populations were used for secondary endpoints, safety summaries, or the reported analyses.

The registry record does not report how missing primary outcome data were handled, whether participants without an evaluable assessment were excluded or classified in a particular way, or what assumptions were made about censoring. It also does not report whether missing secondary data were imputed. These details matter because the interpretation of percentages and time-to-event methods can depend on how incomplete follow-up is handled.

The original statistical analysis plan, interim analysis procedures, and sample-size justification are not reported in the registry record. The record also does not establish whether all listed analyses were prespecified. In the absence of these details, the posted results can be described, but the full analysis strategy and the protection against selective emphasis cannot be evaluated from the registry alone.

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: urinary retention (5.7%), pulmonary embolism (5.7%), anaemia (5.6%), vomiting (5.6%), asthenia (5.6%).

The registry’s serious adverse event summaries list 9 affected participants among 36 at risk in the BN83495 arm, and 6 affected participants among 35 at risk in the MA arm. Other adverse events are listed for 32 among 36 at risk in the BN83495 arm and 29 among 35 at risk in the MA arm. These are posted counts, not adjusted comparisons of safety between treatments.

The registry lists serious adverse event terms with percentages: Urinary Retention, 5.7%; Pulmonary Embolism, 5.7%; Anaemia, 5.6%; Vomiting, 5.6%; Asthenia, 5.6%; and Abdominal Pain Upper, 2.9%. The record does not map these listed percentages to treatment arms in the posted terms, so they should not be assigned to a particular arm. Death counts are not reported in the registry record.

Safety counts are descriptive. The at-risk groups differ between the arm summaries, and the record also lists tolerability outcomes based on exposure, cumulative dose, and interruptions. Without the exposure details and a prespecified comparative safety analysis, the counts alone do not establish a difference in risk.

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

The primary result describes the percentage of trial participants in each arm who had neither progressed nor died by up to 6 months. The posted percentages were 36.1% for BN83495 and 54.1% for MA, with 90% confidence intervals of 24.3% to 49.8% and 40.8% to 66.8%. The unadjusted comparison has p = 0.124. Together, these values describe an observed difference with uncertainty; they do not demonstrate a definitive treatment effect.

A non-significant p-value does not show that the treatments are equivalent, nor does it establish that there is no difference. Equivalence or non-inferiority requires a suitable design, a prespecified margin, and an analysis directed to that question. Such a margin and analysis are not reported in the registry record. Conversely, the numerically higher percentage in the MA group does not by itself prove that MA caused a better outcome.

The interpretation is specific to the trial population and endpoint definition. The registry describes postmenopausal patients with advanced or recurrent endometrial cancer, and defines the primary analysis population as randomized subjects who received at least one dose. Progression assessment was by investigators using RECIST, not by central review, in an open-label study. These details should be kept in mind when considering how the outcome was measured.

The secondary outcomes and safety summaries provide additional description but do not resolve the uncertainty in the primary comparison. The record does not report the complete statistical analysis plan, missing-data procedures, multiplicity handling, or the rationale for the original sample size. The findings therefore support a careful account of the observed data and their precision, rather than a broad claim about treatment efficacy or a conclusion for patients outside the population studied.

17. Why This Trial Matters Statistically

This trial illustrates why an observed difference, a p-value, and confidence intervals should be interpreted together. The primary arm percentages differ numerically, but the unadjusted p-value is 0.124 and the arm-specific 90% confidence intervals cover substantial ranges. Looking only at the point estimates could overstate certainty; looking only at the p-value could obscure the range of effects compatible with the data.

It also highlights the importance of matching a statistical summary to its endpoint. The primary measure is a fixed-time percentage of participants without progression or death, whereas some secondary results are accompanied by Kaplan-Meier analyses. Those summaries answer related but not identical questions and should not be treated as interchangeable. The registry’s investigator-assessed progression endpoint and open-label design are also part of the evidential context.

Finally, the record shows why reporting details matter. The primary population is defined, but the registry does not report the original design assumptions, missing-data approach, multiplicity strategy, or full analysis plan. Planning illustrations based on the observed effect can help explain how sample size relates to detectable effects, but they cannot reconstruct the trial’s original rationale or establish observed power. Statistical interpretation depends not only on results, but also on transparent reporting of how those results were planned and analyzed.

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.
• Participant counts were reconstructed from posted percentages and arm sizes, so small rounding differences are possible.

The primary endpoint relies on investigator assessment using RECIST rather than central review. The study is open label, so treatment assignment was not masked. These features may be relevant to the assessment of progression, but the registry does not quantify their impact or report a central-review sensitivity analysis.

The registry reports enrollment as 73, while primary outcome arm sizes are 36.0 and 37.0. The primary population definition includes randomized subjects who received at least one dose. The record does not explain the relationship between enrollment and the endpoint analysis in further detail, or report missing-data handling, reasons for any non-evaluable outcomes, or sensitivity analyses.

The primary outcome is a fixed-time percentage, and the record does not provide a confidence interval for the between-group comparison in the posted primary fields. It also does not report the exact method used for that comparison. The arm-specific intervals help characterize each estimate but do not supply an interval for the contrast.

Secondary outcomes span different measures and include separate Kaplan-Meier analyses. The registry does not report a multiplicity strategy or enough detail to assess whether all analyses were prespecified. Safety summaries are descriptive, and death counts are not reported in the registry record. The original sample-size justification and full statistical analysis plan are also not reported. These limitations constrain detailed appraisal, but they do not alter the descriptive values recorded for the trial.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: The Study of Oral Steroid Sulphatase Inhibitor BN83495 Versus Megestrol Acetate (MA) in Women With Advanced or Recurrent Endometrial Cancer — NCT00910091.
• Registry record last updated 2019-01-30; status last verified 2019-01.
• Results first posted 2015-09-30.
• 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

NCT00910091 is a completed phase II international, multicentre, randomized, open-label, parallel-group study sponsored by Ipsen. It compared BN83495 40 mg with megestrol acetate 160 mg in women with advanced or recurrent endometrial cancer. The registry lists enrollment as 73 and defines the primary population as randomized subjects who received at least one dose.

The primary outcome was the percentage with neither progression nor death by up to 6 months, assessed by investigators using RECIST rather than central review. The posted percentages are 36.1% for BN83495 and 54.1% for MA; the unadjusted comparison has p = 0.124. The record includes secondary outcome and safety summaries, but does not report the full analysis plan, missing-data procedures, multiplicity handling, or original sample-size justification.