This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record.
1. Trial at a Glance
TEAM was a randomized, parallel, open-label phase 3 treatment trial in breast neoplasms. The registered comparison evaluated exemestane against tamoxifen followed by exemestane, with disease-free survival assessed at 2.75 years and 5 years as the two primary endpoints.
| Feature | TEAM |
|---|---|
| Trial | TEAM |
| NCT ID | NCT00036270 |
| Phase | Phase 3 |
| Status | Completed |
| Condition | Breast Neoplasms |
| Enrollment | 9779 |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None |
| Primary purpose | Treatment |
| Lead sponsor | Pfizer |
| Sponsor type | Industry |
2. Clinical Question
The registered clinical question was whether adjuvant treatment with exemestane differed from tamoxifen followed by exemestane with respect to disease-free survival in postmenopausal, receptor-positive, node-negative or node-positive breast cancer patients.
Population
Postmenopausal, receptor-positive, node-negative or node-positive breast cancer patients represented in the registered disease-free-survival definition.
Intervention
Exemestane (Aromasin).
Comparator
Tamoxifen followed by exemestane.
Primary question
Does the exemestane-only strategy differ in disease-free survival from tamoxifen followed by exemestane during the registered follow-up periods?
3. Trial Design
Exemestane
- Exemestane (Aromasin)
- Evaluated as the test treatment in the registry's primary DFS analyses
Tamoxifen Followed by Exemestane
- Tamoxifen followed by exemestane
- Used as the comparator in the registry's primary and secondary analyses
4. Endpoints
The registry reports two primary endpoints, both measuring disease-free survival over prespecified follow-up periods. Two additional posted analyses address overall survival and time to relapse.
| Endpoint | Registry definition / time frame | Role |
|---|---|---|
| Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years | Number of events (disease relapse or death) to time of observation for DFS. DFS was defined as time from randomization to earliest documentation of disease relapse or death from any cause. Baseline (Month 0) up to 2.75 years. | Primary |
| Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 5 Years | Number of events (disease relapse or death) to time of observation for DFS. DFS was defined as time from randomization to earliest documentation of disease relapse or death from any cause. Baseline (Month 0) up to 5 years. | Primary |
| Number of Events for Overall Survival (OS) | Events defined as death. Baseline (Month 0) up to 5 years. | Secondary |
| Number of Events for Time to Relapse | Events defined as disease relapse. Baseline (Month 0) up to 5 years. | Secondary |
5. Primary Results: Disease-Free Survival at 2.75 Years
The first primary analysis compared disease-free survival between exemestane and tamoxifen followed by exemestane from baseline through 2.75 years. The posted analysis used the ITT population, a log-rank test, a hazard ratio as the effect measure, and adjustment for the overall stratification factor.
Hazard ratio for disease-free survival
95% CI: 0.77–1.03 · P = 0.118
Analysis time frame: Baseline (Month 0) up to 2.75 years.
| Feature | Posted analysis |
|---|---|
| Comparison | Exemestane vs Tamoxifen Followed by Exemestane |
| Analysis population | Intent-to-Treat (ITT) population: all randomized participants |
| Method | Log Rank; Log-rank (Mantel-Cox) |
| Effect measure | Hazard Ratio (HR) |
| Estimate | 0.89 |
| 95% CI | 0.77–1.03 |
| P-value | 0.118 |
| Hypothesis | Superiority |
| Stratification | Adjusted for overall stratification factor; 1 degree of freedom |
The HR of 0.89 means that the estimated hazard of a DFS event in the exemestane-only arm was approximately 11% lower than in the tamoxifen-followed-by-exemestane arm under the reported time-to-event comparison. The direction of the estimate therefore favors exemestane according to the registry's stated convention that an HR below 1 favors the test treatment.
That does not mean that 11% fewer participants experienced relapse or death, nor does it mean that every participant had an 11% reduction in individual risk. A hazard ratio is a relative time-to-event measure, not an absolute event-rate difference or a probability that a particular participant benefits.
The 95% CI of 0.77–1.03 describes uncertainty around the estimated hazard ratio. Because the interval extends above 1, the reported interval includes values corresponding to a higher estimated hazard in the exemestane arm as well as values corresponding to a lower hazard.
The p-value of 0.118 is a measure of compatibility with the specified null hypothesis under the statistical model and testing framework. It is not a measure of the magnitude of the treatment effect and should not be read as a probability that the treatment has no effect.
Importantly, the analysis notes specify a nominal alpha of 0.0302 for the primary endpoint and a significance level of 0.0012 for the interim analysis in order to maintain overall alpha of 0.05. The interpretation therefore needs to account for the prespecified alpha allocation rather than comparing the p-value with an arbitrary threshold alone.
6. Primary Results: Disease-Free Survival at 5 Years
The second primary analysis extended the DFS assessment through 5 years. As with the earlier analysis, participants were analyzed according to randomized treatment assignment, and the comparison used a stratified log-rank framework with a hazard ratio.
Hazard ratio for disease-free survival
95% CI: 0.88–1.08 · P = 0.604
Analysis time frame: Baseline (Month 0) up to 5 years.
| Feature | Posted analysis |
|---|---|
| Comparison | Exemestane vs Tamoxifen Followed by Exemestane |
| Analysis population | ITT population including all randomized participants |
| Method | Log Rank; Log-rank (Mantel-Cox) |
| Effect measure | Hazard Ratio (HR) |
| Estimate | 0.97 |
| 95% CI | 0.88–1.08 |
| P-value | 0.604 |
| Hypothesis | Superiority |
| Stratification | Adjusted for overall stratification factor; 1 degree of freedom |
The HR of 0.97 is close to 1. Under the reported model, the estimated instantaneous hazard of DFS events was approximately 3% lower in the exemestane-only arm than in the comparator arm. The direction is technically toward exemestane because the registry defines an HR below 1 as favoring the test treatment.
The HR should not be interpreted as a 3% difference in the proportion of patients who experienced relapse or death. Time-to-event analyses incorporate both the timing of events and censoring, so the hazard ratio represents a different quantity from an absolute risk difference.
The 95% CI of 0.88–1.08 is relatively close to 1 and spans both directions of possible relative effect. It therefore communicates that the observed estimate is compatible with a range of treatment effects around no difference under the specified statistical framework.
The p-value of 0.604 indicates that the observed data are not statistically unusual under the stated null hypothesis when evaluated using the reported test. It does not establish that the treatments are exactly equivalent, and it does not measure the clinical importance of the HR.
This was a superiority analysis, not a non-inferiority analysis. Consequently, an HR near 1 with a confidence interval around 1 should not be translated into a formal non-inferiority conclusion. Non-inferiority requires a prespecified margin and a corresponding inferential framework, neither of which is reported in the ClinicalTrials.gov record.
7. Comparing the Two Primary DFS Analyses
The two primary analyses illustrate why a clinical-trial result should be read together with its analysis time frame. The 2.75-year and 5-year analyses are not interchangeable estimates: they evaluate the registered DFS endpoint over different observation periods.
| Primary DFS analysis | Estimate | 95% CI | P-value | Analysis time frame |
|---|---|---|---|---|
| DFS at 2.75 years | HR 0.89 | 0.77–1.03 | 0.118 | Baseline (Month 0) up to 2.75 years |
| DFS at 5 years | HR 0.97 | 0.88–1.08 | 0.604 | Baseline (Month 0) up to 5 years |
What is consistent?
Both analyses use the same randomized comparison, ITT principle, log-rank testing, hazard-ratio effect measure, and superiority hypothesis framework.
What changes?
The observation window changes from baseline through 2.75 years to baseline through 5 years, and the estimated HR changes from 0.89 to 0.97.
Why time matters
A time-to-event treatment effect is estimated over follow-up. Changing the time horizon changes the information contributing to the analysis and can change the resulting estimate.
What not to infer
The ClinicalTrials.gov record does not provide median DFS, Kaplan-Meier survival probabilities, event counts by treatment arm, or subgroup-specific estimates. Those quantities should not be reconstructed from the HRs.
8. Secondary Endpoint Results
Overall Survival
Hazard ratio for overall survival
95% CI: 0.89–1.14 · P = 0.951
Analysis time frame: Baseline (Month 0) up to 5 years.
| Feature | Posted analysis |
|---|---|
| Endpoint | Number of Events for Overall Survival (OS) |
| Comparison | Exemestane vs Tamoxifen Followed by Exemestane |
| Analysis population | ITT population including all randomized participants |
| Method | Log Rank; Log-rank (Mantel-Cox) |
| Effect measure | Hazard Ratio (HR) |
| Estimate | 1.00 |
| 95% CI | 0.89–1.14 |
| P-value | 0.951 |
| Hypothesis | Superiority |
An HR of 1.00 is exactly centered on the null value for a hazard-ratio comparison. In the reported analysis, the estimated hazard of death was therefore the same in the two treatment groups at the level of the fitted HR estimate.
The 95% CI of 0.89–1.14 is important because the point estimate alone does not describe uncertainty. The interval includes values below and above 1, so the reported estimate is compatible with either direction of a modest relative difference under the stated model.
The p-value of 0.951 is not evidence that the treatments are mathematically identical. It indicates that the observed test statistic is highly compatible with the null hypothesis of no difference under the reported testing framework. Equivalence would require a different prespecified design and margin.
The registry caveat is also important: the OS outcome is registered as a number of death events, while the statistical analysis is presented as a time-to-event comparison. The ClinicalTrials.gov record does not provide the underlying number of deaths by arm, so no event-count table is constructed here.
Time to Relapse
Hazard ratio for time to relapse
95% CI: 0.83–1.06 · P = 0.293
Analysis time frame: Baseline (Month 0) up to 5 years.
| Feature | Posted analysis |
|---|---|
| Endpoint | Number of Events for Time to Relapse |
| Comparison | Exemestane vs Tamoxifen Followed by Exemestane |
| Analysis population | ITT population including all randomized participants |
| Method | Log Rank; Log-rank (Mantel-Cox) |
| Effect measure | Hazard Ratio (HR) |
| Estimate | 0.94 |
| 95% CI | 0.83–1.06 |
| P-value | 0.293 |
| Hypothesis | Superiority |
The HR of 0.94 corresponds to an approximately 6% lower estimated hazard of relapse in the exemestane-only arm under the reported model. The estimate therefore points toward the test treatment, but its magnitude should not be interpreted as a 6% reduction in the probability of relapse.
The 95% CI of 0.83–1.06 crosses 1. This indicates uncertainty in the direction and magnitude of the relative treatment effect. The confidence interval is more informative than the point estimate alone because it shows the range of effect estimates supported by the statistical procedure.
The p-value of 0.293 does not measure the size of the observed HR. A relatively modest p-value and a modest HR are separate statistical concepts: one describes compatibility with a null hypothesis, while the other describes the estimated relative event hazard.
9. Statistical Methodology
Log-rank test
All four posted statistical analyses use the log-rank method, reported specifically as the Mantel-Cox log-rank test. This is a standard approach for comparing time-to-event distributions between randomized treatment groups.
The log-rank test evaluates the observed pattern of events over follow-up rather than reducing each participant to a simple event/no-event indicator.
For each event time, the analysis considers the participants who remain at risk immediately before that time. The resulting test statistic accumulates information across the follow-up period. This is particularly useful when some participants are censored before experiencing the event.
Hazard ratio
The registry reports hazard ratio as the effect measure for DFS, OS, and time to relapse. For these analyses, an HR below 1 favors the exemestane-only test treatment.
An HR below 1 indicates a lower estimated instantaneous event hazard in the exemestane-only group under the reported analysis. It is not an absolute risk ratio or an individual-level probability.
Intention-to-treat analysis
The primary and secondary time-to-event analyses were based on the ITT population. The registry defines this population as participants randomized to one of the two study arms, meaning the comparison is anchored to randomized assignment rather than selectively excluding participants after randomization.
This distinction is fundamental to randomized-trial inference. Randomization establishes the treatment groups before subsequent outcomes occur. Preserving participants according to their randomized assignment helps retain that design-based comparison even when follow-up or treatment exposure is not identical for every participant.
Stratified analysis
The posted analyses state that the log-rank comparison was adjusted for the overall stratification factor. The registry also identifies stratified analysis and covariate adjustment among the concepts represented in the statistical analysis text.
A stratified survival analysis allows the comparison to account for the trial's overall stratification structure rather than assuming that every participant contributes to one completely homogeneous risk set. The ClinicalTrials.gov record does not identify the individual stratification variables, so this page does not assign specific clinical factors to that adjustment.
Censoring and time-to-event data
Time-to-event analyses differ from analyses based solely on whether an event eventually occurred. Participants who have not experienced the event by the end of their available observation can contribute information until their censoring time. The validity of the resulting inference depends on appropriate handling and assumptions concerning censoring and the underlying event process.
10. Statistical Methods Explained
Why use a log-rank test for DFS?
DFS is registered as a time-to-event endpoint: it measures time from randomization to the earliest documentation of disease relapse or death. A log-rank test is designed to compare event-time distributions between randomized groups while using the timing of events and available follow-up information.
What does an HR of 0.89 mean?
An HR of 0.89 means that the estimated hazard of the event in the exemestane-only group was approximately 11% lower than in the comparator group under the reported analysis. It does not mean that 11% of participants benefited or that the absolute probability of relapse or death was reduced by 11 percentage points.
Why is the confidence interval as important as the HR?
The HR is a point estimate. The 95% confidence interval describes statistical uncertainty around that estimate. For the 2.75-year DFS analysis, the interval is 0.77–1.03; for the 5-year analysis, it is 0.88–1.08. In both cases, the interval extends across 1, which is the null value for a hazard ratio.
Why doesn't the p-value measure treatment effect size?
A p-value evaluates the compatibility of the observed data with a specified null hypothesis under the analysis framework. Effect size is described by the HR and its confidence interval. Thus, a p-value of 0.604 does not mean the treatment effect is "60.4%"; it is a probability-scale summary associated with the statistical test, not a treatment-effect measure.
Why analyze the ITT population?
The ITT approach keeps randomized participants in the treatment group to which they were assigned. This protects the comparison created by randomization and avoids redefining the treatment groups based on events that occurred after assignment.
Why does the analysis mention stratification?
The registry states that the log-rank analyses were adjusted for the overall stratification factor. Stratification can account for the design structure used when randomization was performed and can improve the alignment between the analysis and the randomized trial design.
11. Interim Analysis and Alpha Spending
The 2.75-year primary analysis contains explicit information about interim monitoring. The analysis notes state that, to maintain an overall alpha of 0.05, two adjustments were made: a nominal alpha of 0.0302 was used for the primary endpoint, and a significance level of 0.0012 was used for the interim analysis.
Why interim monitoring matters
Looking at accumulating trial data more than once creates a multiple-testing problem if each look is treated as though it were the only analysis. Prespecified alpha allocation controls the overall type I error across the planned looks.
What the alpha values tell us
The registry's reported values show that the interim analysis used a much more stringent significance level than the nominal alpha assigned to the primary endpoint.
These values are reported by the registry and are part of the interpretation of the 2.75-year primary analysis.
This is important because the reported p-value of 0.118 should be interpreted within the trial's prespecified testing framework. It is not appropriate to ignore the documented alpha allocation and substitute a generic threshold without qualification.
12. Multiplicity and the Two Primary Endpoints
TEAM has two registered primary DFS endpoints, corresponding to different follow-up periods: baseline through 2.75 years and baseline through 5 years. The registry-reported analysis notes explicitly describe alpha adjustment for the primary endpoint and interim analysis.
| Component | Role in the ClinicalTrials.gov record | Statistical implication |
|---|---|---|
| DFS through 2.75 years | Primary endpoint | Nominal alpha 0.0302; interim significance level 0.0012 also reported |
| DFS through 5 years | Primary endpoint | Nominal alpha 0.0302 reported |
| Overall survival through 5 years | Secondary endpoint | Overall alpha of 0.05 was maintained |
| Time to relapse through 5 years | Secondary endpoint | Overall alpha of 0.05 was maintained |
Multiplicity matters because a trial can generate many estimates and p-values. The ClinicalTrials.gov record explicitly document how alpha was handled for the reported analyses, so those details should remain attached to the corresponding results rather than being omitted from interpretation.
13. Safety Results
The ClinicalTrials.gov record reports serious adverse events by randomized treatment arm. They do not provide a separate serious-adverse-event effect estimate or p-value in the posted statistical analyses in the ClinicalTrials.gov record.
| Safety measure | Participants affected | Participants at risk |
|---|---|---|
| Serious adverse events — Tamoxifen Followed by Exemestane | 784 | 4814 |
| Serious adverse events — Exemestane | 831 | 4852 |
The registry reports 784/4814 participants affected by serious adverse events in the tamoxifen-followed-by-exemestane arm and 831/4852 in the exemestane arm. These are descriptive safety data.
They should not be converted into a formal comparative risk estimate here because the ClinicalTrials.gov record does not report a statistical analysis for serious adverse events. A formal comparison could use an appropriate binary-outcome method, but the resulting estimate would be an analysis not contained in the ClinicalTrials.gov record and therefore is not added to this page.
It is also important not to confuse the number affected with the number of adverse-event episodes. The registry-reported field is explicitly structured as affected participants over participants at risk.
14. What the Hazard Ratio Does — and Does Not — Mean
The hazard ratio is a relative time-to-event measure. For example, the 5-year DFS HR of 0.97 indicates an estimated hazard approximately 3% lower in the exemestane-only group under the reported model. It does not imply that the absolute probability of disease relapse or death was 3% lower.
The 95% CI communicates uncertainty around the estimated HR. The 5-year DFS interval of 0.88–1.08 spans the null value of 1. A confidence interval is not a range containing a specified percentage of individual patients' treatment effects; it describes uncertainty in the estimated population parameter under the statistical framework.
The p-value addresses the statistical test of the stated null hypothesis. It does not measure clinical magnitude. An HR of 0.89 and a p-value of 0.118 answer different questions: the HR describes the estimated relative event hazard, while the p-value summarizes the evidence against the null under the specified test.
Because DFS, OS, and time to relapse are time-to-event outcomes, the analysis uses information about when participants were observed and when events occurred. Participants without an observed event by the end of available follow-up do not simply become equivalent to participants who never experienced the event; their observation is handled through the time-to-event framework.
A single hazard ratio summarizes a relative hazard over the analyzed follow-up. Interpretation is most straightforward when the proportional-hazards structure is reasonable. The ClinicalTrials.gov record does not report a formal assessment of the proportional-hazards assumption, so this page does not claim that the assumption was demonstrated.
15. Secondary Endpoints in Context
| Endpoint | HR | 95% CI | P-value | Interpretive direction |
|---|---|---|---|---|
| DFS through 2.75 years | 0.89 | 0.77–1.03 | 0.118 | HR below 1 favors exemestane |
| DFS through 5 years | 0.97 | 0.88–1.08 | 0.604 | HR below 1 favors exemestane |
| Overall survival through 5 years | 1.00 | 0.89–1.14 | 0.951 | HR = 1 at the point estimate |
| Time to relapse through 5 years | 0.94 | 0.83–1.06 | 0.293 | HR below 1 favors exemestane |
The table demonstrates why it is preferable to examine the complete statistical result rather than a single number. The estimates differ by endpoint and follow-up period, while the confidence intervals provide information about precision and the p-values address the corresponding hypothesis tests.
The ClinicalTrials.gov record does not include median DFS, median OS, Kaplan-Meier point estimates, subgroup results, or individual event counts by treatment group. Those quantities are therefore intentionally absent rather than reconstructed from the available hazard ratios.
16. Trial Timeline
Trial start
The registry lists August 2001 as the study start.
Primary completion
The registry lists October 2008 as the primary completion date.
Registry status
The trial is listed as completed, with results posted on ClinicalTrials.gov.
17. Statistical Reading of the Primary DFS Results
The most important statistical feature of TEAM is that the same clinical endpoint is represented at two different registered follow-up periods. This makes it a useful example of why a time-to-event estimate cannot be detached from its analysis horizon.
At 2.75 years
The estimated DFS HR was 0.89 with a 95% CI of 0.77–1.03 and P = 0.118.
At 5 years
The estimated DFS HR was 0.97 with a 95% CI of 0.88–1.08 and P = 0.604.
Direction
Both point estimates are below 1, which according to the registry's convention favors the exemestane-only arm.
Precision
Both confidence intervals cross 1, so neither point estimate alone should be treated as establishing a precise direction of the underlying treatment effect.
A particularly important distinction is between absence of evidence for a difference and evidence of exact equivalence. These are not the same statistical statement. The registry-reported TEAM analyses are superiority analyses. They do not provide a non-inferiority margin that could be used to make a non-inferiority conclusion, nor do they establish formal equivalence.
18. Limitations
- Registry-level information: This analysis is restricted to the ClinicalTrials.gov record and the permitted source records. It does not supplement missing results from other publications or external databases.
- Incomplete descriptive survival information: The ClinicalTrials.gov record does not report median DFS, median OS, Kaplan-Meier estimates, or treatment-specific event counts for the primary endpoints.
- Overall survival reporting: The registry caveat states that OS was reported as a number of events that would otherwise be reported as time. The ClinicalTrials.gov record does not contain the corresponding event counts.
- Stratification detail: The analyses state that they were adjusted for the overall stratification factor, but the ClinicalTrials.gov record does not identify the underlying stratification variables.
- Proportional-hazards assessment: The ClinicalTrials.gov record does not report a formal assessment of the proportional-hazards assumption.
- Safety inference: Serious adverse events are reported descriptively by arm, without a registry-reported formal comparative statistical analysis.
- Subgroups: No subgroup-specific effect estimates are included in the ClinicalTrials.gov record, so no subgroup conclusions are drawn.
- Non-inferiority interpretation: The analyses use a superiority hypothesis. No non-inferiority margin is reported, so the results should not be reframed as a non-inferiority analysis.
- Missing-data methods: The registry-reported statistical analysis descriptions do not specify an imputation strategy for missing observations. No particular imputation method is therefore attributed to the trial.
19. Why This Trial Matters Statistically
TEAM is a useful statistical teaching case because it combines randomized treatment assignment with multiple time-to-event endpoints, stratified log-rank analysis, hazard-ratio estimation, ITT analysis, and documented interim alpha control.
| Concept | How it appears in TEAM |
|---|---|
| Randomization | Participants were randomized to one of two parallel treatment arms. |
| Intention-to-treat analysis | Primary and secondary analyses used the ITT population of randomized participants. |
| Time-to-event endpoints | DFS, OS, and time to relapse were analyzed over specified follow-up periods. |
| Log-rank test | All four posted statistical analyses used the log-rank method. |
| Hazard ratio | HR was the reported effect measure for all four posted analyses. |
| Confidence intervals | Each posted HR includes a two-sided 95% CI. |
| Stratified analysis | The posted analyses were adjusted for the overall stratification factor. |
| Interim analysis | The 2.75-year analysis notes a separate interim significance level of 0.0012. |
| Alpha spending / error control | The registry reports adjustments used to maintain overall alpha of 0.05. |
| Superiority testing | The primary and secondary statistical analyses are classified as superiority hypotheses. |
20. A Practical Framework for Reading TEAM
A useful way to interpret the trial is to move from design to estimand to estimate and finally to uncertainty.
First, randomization defines the treatment comparison. Second, the endpoint defines what event and time scale are being studied. Third, the log-rank test and hazard ratio provide the inferential framework. Fourth, the HR supplies a relative effect estimate. Finally, the confidence interval and p-value describe uncertainty and compatibility with the prespecified null hypothesis.
This sequence prevents a common statistical mistake: treating the p-value as the result itself. The p-value is only one component. A complete interpretation needs the endpoint, analysis population, time frame, effect estimate, confidence interval, testing framework, and relevant assumptions.
21. Related Tutorials
Learn more about the methods used in this trial:
22. Related Calculators
23. Sources
- ClinicalTrials.gov: TEAM — NCT00036270.
- PubMed: PMID 41642493.
- PubMed: PMID 35100692.
- PubMed: PMID 32706636.
- PubMed: PMID 29885375.
- PubMed: PMID 24091623.
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24. Record Summary
TEAM is a randomized phase 3, parallel, unmasked trial with 9779 enrolled participants and two treatment arms. Its two primary endpoints are disease-free survival from baseline through 2.75 years and through 5 years. Both were analyzed in the ITT population using a log-rank framework and hazard ratios, with adjustment for the overall stratification factor.
The posted DFS estimates were HR 0.89 (95% CI 0.77–1.03; P = 0.118) through 2.75 years and HR 0.97 (95% CI 0.88–1.08; P = 0.604) through 5 years. Secondary analyses reported HR 1.00 (95% CI 0.89–1.14; P = 0.951) for overall survival and HR 0.94 (95% CI 0.83–1.06; P = 0.293) for time to relapse through 5 years.
The most important statistical lesson is that these estimates must be interpreted together with their time frames, randomized analysis population, log-rank methodology, stratification, confidence intervals, p-values, and documented alpha control. The ClinicalTrials.gov record does not provide enough information to reconstruct median survival, Kaplan-Meier curves, treatment-specific event counts, or subgroup effects, so those quantities are not inferred here.