This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Phase II Trial of EVEROLIMUS ± Trastuzumab in Hormone-Refractory Metastatic Breast Cancer (NCT00912340), a randomized phase 2 study. The primary outcome is Progression-free Survival (PFS) Until First Progression.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00912340 |
| Phase | Phase 2 |
| Condition | Breast Cancer |
| Allocation | Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 70 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Emory University |
| Results posted | Yes |
2. Clinical Question
Population
Patients with breast cancer that had not responded to hormone therapy and had spread from its original site to other parts of the body. The registry describes a phase II trial and records an overall enrollment of 70. The primary-outcome description says that four patients treated with trastuzumab and everolimus up front were excluded from the data analysis because that arm was later discontinued.
Intervention
Everolimus was given daily while patients continued their most recent hormone therapy. The registry describes trastuzumab being added after disease progression in this group. In the other analyzed group, patients received trastuzumab every three weeks while continuing hormone therapy, with everolimus added after progression.
Comparator
The reported primary-outcome groups are everolimus and trastuzumab. The registry lists trastuzumab as the control group. A separate trastuzumab-and-everolimus arm was removed; four patients received both drugs up front, but they were not included in the primary data analysis.
Primary question
The primary endpoint was median progression-free survival until first progression, measured in months. It describes the time to disease progression or death in each reported group. The registry reports a median and 95% confidence interval for each analyzed group, but does not provide a hazard ratio or a formal between-group test result.
The trial’s question concerns how progression-free survival was observed under treatment strategies involving everolimus and trastuzumab, including the addition of the other drug after progression. It is not a simple comparison of two treatments that each remained unchanged throughout follow-up: both group descriptions include continued hormone therapy, and both include a treatment change after progression. The four-patient upfront combination group was discontinued and excluded from the primary analysis, so its experience is not represented by the reported primary endpoint estimates.
The registry describes random allocation, but also records a single-group model. It does not explain this apparent inconsistency. The posted results allow a descriptive reading of the two reported median PFS estimates and their uncertainty. They do not establish from the reported statistics whether the group outcomes differ beyond what could be due to sampling variability, nor do they establish a causal effect of one strategy relative to the other.
3. Trial Design
This was a phase II trial sponsored by Emory University. The registry records random allocation and no masking, while also describing the trial model as single group. The relationship between those design descriptors is not explained in the registry record. Enrollment was 70, and the record marks the study as completed.
The analyzed treatment strategies began with either everolimus or trastuzumab, with each group continuing its most recent hormone therapy. According to the arm descriptions, patients who experienced disease progression received the other study drug in combination with the initial study drug and hormone therapy. Thus, the strategies included treatment after progression as well as the initial treatment. The registry also lists a trastuzumab-and-everolimus arm that was removed. Its primary-outcome description states that four patients received both agents up front and were not included in the data analysis because the arm was later discontinued.
For the primary outcome, the registry reports 24.0 participants in the trastuzumab group and 30.0 in the everolimus group. The removed upfront-combination arm has no reported primary-outcome estimate. The registry gives the primary assessment timeframe as every 3 to 4 weeks after study start, until progression or death, assessed up to 5 years. It does not provide further operational detail about assessment procedures, adherence, treatment discontinuation, or how progression was determined.
A secondary outcome is listed as progression-free survival in patients who crossed over. A numerical result for that outcome is not reported in the registry record. The record does not report a detailed statistical analysis plan, the method used to account for random allocation, or the rationale for the design descriptors. Those omissions limit how fully the design and the reported arm estimates can be interpreted.
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: 70 participants were enrolled. Nine were found to be ineligible. Three declined to participate and were not treated.
Overall Study
| Stage | Trastuzumab | Everolimus | Trastuzumab and Everolimus (ARM REMOVED) |
|---|---|---|---|
| STARTED | 24 | 30 | 4 |
| COMPLETED | 22 | 26 | 0 |
| NOT COMPLETED | 2 | 4 | 4 |
Reasons for not completing this period:
| Reason | Trastuzumab | Everolimus | Trastuzumab and Everolimus (ARM REMOVED) |
|---|---|---|---|
| Adverse Event | 2 | 4 | 0 |
| Protocol revised to remove arm | 0 | 0 | 4 |
Analysis population for the primary outcome, as defined in the registry: Four patients were treated with both trastuzumab \& everolimus up front. These patients were not included in the data analysis because this arm was later discontinued.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Trastuzumab | Everolimus | Trastuzumab and Everolimus (ARM REMOVED) | Total |
|---|---|---|---|---|---|
| Participants analysed | 24 | 30 | 4 | 58 | |
| Age, Customized: Age range 30-39 | Participants | 2 | 0 | 0 | 2 |
| Age, Customized: Age range 40-49 | Participants | 2 | 5 | 0 | 7 |
| Age, Customized: Age range 50-59 | Participants | 9 | 8 | 0 | 17 |
| Age, Customized: Age range 60-69 | Participants | 4 | 9 | 4 | 17 |
| Age, Customized: Age range 70-79 | Participants | 7 | 7 | 0 | 14 |
| Age, Customized: Age range 81-89 | Participants | 0 | 1 | 0 | 1 |
| Sex: Female, Male: Female | Participants | 23 | 30 | 4 | 57 |
| Sex: Female, Male: Male | Participants | 1 | 0 | 0 | 1 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 1 | 0 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 23 | 26 | 4 | 53 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 3 | 0 | 4 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 1 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 9 | 3 | 1 | 13 |
| Race (NIH/OMB): White | Participants | 15 | 24 | 2 | 41 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 3 | 0 | 3 |
| Region of Enrollment: United States | participants | 24 | 30 | 4 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Progression-free Survival (PFS) Until First Progression, measured over Every 3 to 4 weeks after study start, until progression or death, assessed up to 5 years.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint is progression-free survival until first progression, summarized as a median in months. The registry defines the measure as time to first progression or death. In general, a time-to-event endpoint records the time until a specified event occurs; participants who have not had the event by the end of their observed follow-up may contribute information up to that point, depending on the analysis method.
The median is the point in the estimated event-time distribution at which half of the observed population has experienced the event and half has not. It offers a readily interpretable summary of the timing of progression or death, while avoiding reliance on a mean when follow-up times may be uneven or the distribution may be skewed. The registry reports median PFS of 2.0 months for trastuzumab, with a 95% confidence interval of 1.6 to 4.1 months, and 5.7 months for everolimus, with a 95% confidence interval of 3.9 to 8.9 months.
These estimates summarize each group separately. They do not, by themselves, quantify a comparative treatment effect or show whether the difference between groups is statistically distinguishable from chance. The registry does not report a hazard ratio or a formal comparison for this endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports median progression-free survival of 2.0 months in the trastuzumab group, with a 95% confidence interval of 1.6 to 4.1 months. For the everolimus group, the reported median is 5.7 months, with a 95% confidence interval of 3.9 to 8.9 months. These are group-specific summaries of time to first progression or death. Their confidence intervals convey uncertainty around the estimated medians; they are not ranges containing every participant’s experience.
The intervals are broad enough to matter when interpreting the estimates. A confidence interval describes the uncertainty associated with an estimate under the analysis assumptions; it is not a guarantee that the true value lies inside the interval. The registry does not provide a formal test of the difference between the groups, a hazard ratio, or a comparative confidence interval. Therefore the two medians should not be treated as a complete inferential comparison. In particular, no p-value for the primary comparison is reported in the registry record.
The group estimates also need to be read in light of the treatment strategies. Patients in both described groups continued hormone therapy, and the treatment descriptions include adding the other study drug after progression. The primary endpoint is defined as time to first progression or death, so the reported medians concern the period up to that first event, not the later crossover experience. The separately listed crossover PFS outcome has no numerical result reported in the registry record.
The upfront combination arm requires separate attention. Four patients received trastuzumab and everolimus together at the outset, but the primary-outcome description says those patients were excluded from data analysis after the arm was discontinued. The primary results therefore do not provide an estimate for that upfront combination strategy. The removed arm’s record of no primary-outcome estimate should not be mistaken for evidence that its outcome was zero or that no patients received treatment.
The record’s design labels are not fully aligned: it lists random allocation and a single-group model, without explaining the discrepancy. The registry also does not provide enough detail to assess all aspects of the analysis, such as how censoring was handled or how the analysis population was defined beyond the stated exclusion. The posted results support a descriptive account of the reported medians and intervals, but the available information does not support a definitive causal comparison or a conclusion about treatment efficacy.
9. Statistical Methods Explained
Progression-free survival is a time-to-event outcome: the event is the first disease progression or death. For each participant, the analysis uses the time from the defined start point until the event, or until the participant’s last relevant observation if the event has not been recorded. General statistical practice for this kind of endpoint accounts for participants whose event time is not observed during follow-up through censoring. The registry gives the endpoint definition and assessment timeframe, but the censoring rules and the specific estimator used are not reported in the registry record.
What does the median describe?
In general, the median event time is the estimated time by which half of the population has experienced the event. It is a distribution summary, not an average of all individual follow-up times. A median can be useful when event times are not symmetrically distributed or when some participants remain event-free at the end of observation. The registry states that median PFS will be calculated based on time to first progression or death, and posts estimates for two groups.
The trastuzumab estimate is 2.0 months, with a 95% confidence interval of 1.6 to 4.1 months. The everolimus estimate is 5.7 months, with a 95% confidence interval of 3.9 to 8.9 months. The confidence interval reflects statistical uncertainty around the estimated median under the analysis method. It does not describe the spread of individual participant outcomes, and it does not mean that all or most participants had event times within its bounds. Confidence intervals are also not a substitute for a direct comparison between groups.
How should the confidence intervals be read?
In general, a 95% confidence interval is produced by a procedure that, under its assumptions, would cover the fixed quantity of interest in 95% of repeated applications. For an individual trial, it communicates how imprecisely the quantity has been estimated. A wider interval indicates less precision than a narrower interval, though the registry record does not state the calculation method or provide enough information to independently assess the intervals. The endpoints should be read alongside the estimates, not as separate outcomes.
The posted primary results are medians with confidence intervals, rather than hazard ratios. A hazard ratio is a comparative measure used in some time-to-event analyses; it relates event rates over follow-up under the model used. It would not be interchangeable with the difference between medians. No hazard ratio or primary comparison test result is reported in the registry record, so neither a comparative effect estimate nor its precision can be described from these results.
Why can two medians not establish a treatment effect?
Each median describes one group. A comparison requires an analysis that accounts for the trial design and the event-time data, including follow-up and censoring. General statistical inference for randomized groups can use methods designed for time-to-event outcomes, but the record does not report which comparative method was used, whether any adjustment was made, or whether an analysis plan specified a particular model. It would be inappropriate to infer a p-value or comparative effect from the two medians alone.
Even when allocation is randomized, interpretation depends on knowing which participants were included, how participants were followed, and how treatment changes were handled. Here, both group descriptions include adding the other study drug after progression, and the registry separately lists PFS among patients who crossed over. The primary endpoint ends at first progression or death, so it does not describe outcomes after that event. The crossover result is not reported in the registry record.
What do the planning illustrations mean?
General sample-size planning calculations use assumptions about the effect to detect, the allocation between groups, the significance level, and the statistical model. The planning illustrations associated with these results are based on the observed effect rather than the trial’s own design. They use a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is expressed as a stated fraction of the observed effect. For time-to-event outcomes, the calculation is expressed as a total number of events using the Schoenfeld method. These assumptions describe an illustration, not the original trial’s sample-size justification.
Such planning results are not observed power and do not show the probability that the trial’s findings are true. They are hypothetical estimates of the information needed under stated assumptions. The trial’s own sample-size justification is not reported in the registry record. No extra planning results should be interpreted as the number of participants or events actually observed.
Finally, the registry records random allocation but also labels the model single group. The statistical meaning of that combination is not explained. The record does not report interim analyses, multiplicity procedures, or the full statistical analysis plan. Those details would be needed for a more complete assessment of the analysis choices and the strength of any comparative inference.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary outcome and one secondary outcome, progression-free survival in patients who crossed over. It reports the primary endpoint medians, but does not report a numerical result for the crossover outcome. The number of outcome measures is recorded as 2, while no analysis count is posted. The record does not explain whether all planned outcomes were reported or whether additional analyses were conducted outside the registry entry.
When a study examines multiple outcomes or makes multiple comparisons, the chance of at least one apparently unusual result can increase. General statistical approaches may address this multiplicity, but the registry does not report a multiplicity adjustment or a prespecified testing hierarchy. It is therefore not possible to determine from the record how multiplicity was handled or whether the primary outcome was protected from other testing.
Information about missing observations is also limited. The registry provides arm sizes and endpoint estimates, but does not report the number censored, the reasons for missing follow-up, or how incomplete observations were handled. For a time-to-event analysis, censoring can allow a participant’s observed follow-up to contribute information even if progression or death was not recorded, but the assumptions and implementation matter. These are not described in the registry record.
The primary-outcome description explicitly excludes four patients treated with both drugs up front because that arm was discontinued. It does not give further detail on the analysis population for the other groups, the handling of participants who crossed over after progression, or whether the analysis followed initial allocation. The registry also does not report interim-analysis procedures, a detailed statistical analysis plan, or a sample-size justification. These omissions limit assessment of reporting completeness and the robustness of the estimates.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Trastuzumab | 1 | 24 | 4.2% |
| Everolimus | 6 | 30 | 20.0% |
| Trastuzumab and Everolimus (ARM REMOVED) | 0 | 4 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Trastuzumab | 9 of 24 |
| Everolimus | 8 of 30 |
| Trastuzumab and Everolimus (ARM REMOVED) | 3 of 4 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 3% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Trastuzumab | 0 of 24 |
| Everolimus | 12 of 30 |
| Trastuzumab and Everolimus (ARM REMOVED) | 0 of 4 |
Most frequent serious adverse event terms
| Event term | Organ system | Trastuzumab | Everolimus | Trastuzumab and Everolimus (ARM REMOVED) |
|---|---|---|---|---|
| Pericardial effusion | Cardiac disorders | 1 of 24 | 1 of 30 | 0 of 4 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 0 of 24 | 2 of 30 | 0 of 4 |
| Other cardiac disorder | Cardiac disorders | 0 of 24 | 1 of 30 | 0 of 4 |
| Ejection fraction decrease | Cardiac disorders | 0 of 24 | 1 of 30 | 0 of 4 |
| Hypertension | General disorders | 0 of 24 | 1 of 30 | 0 of 4 |
| Salivary gland infection | Infections and infestations | 0 of 24 | 1 of 30 | 0 of 4 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Trastuzumab | Everolimus | Trastuzumab and Everolimus (ARM REMOVED) |
|---|---|---|---|---|
| Mucositis oral | Gastrointestinal disorders | 0 of 24 | 2 of 30 | 0 of 4 |
| Fatigue | General disorders | 0 of 24 | 2 of 30 | 0 of 4 |
| Hypertriglyceridemia | Metabolism and nutrition disorders | 0 of 24 | 2 of 30 | 0 of 4 |
| Decreased ejection fraction | Investigations | 0 of 24 | 2 of 30 | 0 of 4 |
| Hypertension | Vascular disorders | 0 of 24 | 2 of 30 | 0 of 4 |
| Aspartate aminotransferase (AST) increased | Investigations | 0 of 24 | 1 of 30 | 0 of 4 |
| Alanine aminotransferase (ALT) increased | Investigations | 0 of 24 | 1 of 30 | 0 of 4 |
| Creatinine increased | Investigations | 0 of 24 | 1 of 30 | 0 of 4 |
| Edema limbs | General disorders | 0 of 24 | 1 of 30 | 0 of 4 |
| Colitis | Gastrointestinal disorders | 0 of 24 | 1 of 30 | 0 of 4 |
Serious events with the highest arm-level rate: pleural effusion (6.7%), pericardial effusion (4.2%), other cardiac disorder (3.3%), ejection fraction decrease (3.3%), hypertension (3.3%).
The registry reports serious adverse events as the number at risk and the number affected in each group. In the trastuzumab group, 24 participants were at risk and 1 was affected. In the everolimus group, 30 were at risk and 6 were affected. For the removed upfront-combination group, 4 were at risk and 0 were affected. These are counts recorded for the registry’s serious-event category; the record does not provide further detail about the observation period or event-attribution process.
The registry separately reports other adverse events: 0 of 24 in the trastuzumab group, 12 of 30 in the everolimus group, and 0 of 4 in the removed combination group. These categories should not be conflated. The record does not give enough detail to establish whether events were judged related to treatment, how repeated events in a participant were counted, or whether the groups had identical exposure and follow-up.
Deaths are listed as 9, 8, and 3 for the trastuzumab, everolimus, and removed combination groups, respectively. These counts do not establish that deaths were caused by study treatment; the registry does not provide that causal attribution. Listed serious-event terms include pleural effusion at 6.7%, pericardial effusion at 4.2%, and other cardiac disorder, ejection fraction decrease, hypertension, and salivary gland infection at 3.3% each. The record does not provide enough context to interpret those percentages as comparative risks.
12. What the Result Does, and Does Not, Mean
The registry’s primary results show two median PFS estimates: 2.0 months for trastuzumab, with a 95% confidence interval of 1.6 to 4.1 months, and 5.7 months for everolimus, with a 95% confidence interval of 3.9 to 8.9 months. These figures describe the reported groups’ time to first progression or death. They are estimates, and their confidence intervals indicate that the medians are not known with exact precision.
The results do not, on their own, establish that one strategy caused a longer or shorter PFS than the other. A formal comparative estimate and its uncertainty are not reported in the registry record. Nor does the record provide a p-value for the primary comparison. The medians should therefore be read as descriptive group summaries, not as a complete statistical test of treatment effect.
The trial strategies included continued hormone therapy and treatment changes after progression. Since the primary endpoint stops at the first progression or death, it does not evaluate the effect of later crossover treatment. Although the registry lists PFS among patients who crossed over as a secondary outcome, its numerical result is not reported in the registry record. Four patients received the combination up front, but the primary analysis excluded them after the arm was discontinued; no primary estimate is available for that strategy.
More broadly, the posted information does not support conclusions beyond the measured outcomes and reported groups. The registry does not report the full analysis plan, the handling of missing observations, a sample-size justification, or a multiplicity approach. The apparent mismatch between random allocation and the single-group model is also unexplained. Those limits affect how confidently the results can be interpreted as comparative evidence. The results do not constitute medical advice and do not determine what treatment is appropriate for an individual.
13. Why This Trial Matters Statistically
This trial illustrates why a time-to-event result needs to be interpreted with its estimand and analysis details in view. The primary endpoint is time until first progression or death, summarized by a median. That endpoint focuses on the initial period before the first event; it does not describe what happens after progression, even though the treatment descriptions include adding the other study drug after progression.
The record also illustrates the difference between a group-specific estimate and a treatment comparison. It gives a median and 95% confidence interval for each analyzed group, but does not report a hazard ratio, comparative confidence interval, or p-value. Reporting the two medians is informative descriptively, while leaving the comparative question unresolved in the posted statistics. A reader should not substitute a comparison of the two point estimates for a direct analysis of the time-to-event data.
The discontinued upfront combination arm is another important statistical feature. Four patients received both drugs up front but were excluded from the primary data analysis. That exclusion means the primary endpoint results do not describe the upfront combination strategy. The separate count of four at risk in the safety record does not change the stated primary-analysis exclusion.
Finally, the registry’s design labels and reporting gaps matter. Random allocation and a single-group model are both recorded, but their relationship is not explained. The record also does not report details such as the analysis plan, missing-data handling, multiplicity procedures, or the trial’s sample-size rationale. These issues show why registry results are best read in context: a numerical endpoint can be stated precisely while important information needed for broader inference remains unavailable.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several trial-specific limitations are apparent from the registry record. Although random allocation is recorded, the trial model is also described as single group, and the record does not reconcile those descriptions. The posted statistics therefore do not clarify how the randomized design maps to the analyzed groups or how allocation was accounted for in the analysis.
The primary outcome is reported for the trastuzumab and everolimus groups, but the registry does not provide a hazard ratio, a formal comparison result, or a comparative confidence interval. It also does not describe the estimator, censoring rules, or detailed analysis population. These omissions make it difficult to assess the statistical precision and comparability of the group estimates beyond their reported medians and intervals.
The upfront combination arm was discontinued. Four patients received both drugs up front and were excluded from primary analysis, leaving no primary endpoint estimate for that strategy. The registry does not explain the reason for discontinuation beyond stating that the arm was later discontinued. The secondary crossover PFS outcome is listed without a numerical result.
Other details important to interpreting the findings are not reported in the registry record: a sample-size justification, interim-analysis procedures, multiplicity handling, missing-data methods, and a full statistical analysis plan. Safety-event definitions and attribution details are also not provided in the summary information. These limitations do not change the posted results, but they constrain what can be concluded from them.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Phase II Trial of EVEROLIMUS ± Trastuzumab in Hormone-Refractory Metastatic Breast Cancer — NCT00912340.
- Registry record last updated 2018-12-05; status last verified 2018-11.
- Results first posted 2018-12-05.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry describes a completed phase II trial of everolimus with or without trastuzumab in hormone-refractory metastatic breast cancer, sponsored by Emory University, with enrollment of 70. It records random allocation and no masking, while also identifying a single-group model; the relationship between these design labels is not explained.
The primary outcome was median PFS until first progression or death. The reported medians were 2.0 months for trastuzumab and 5.7 months for everolimus, with respective 95% confidence intervals of 1.6 to 4.1 months and 3.9 to 8.9 months. Four patients treated with the combination up front were excluded from primary analysis after that arm was discontinued. A crossover PFS outcome is listed, but its result is not reported in the registry record.
The record does not report a formal primary comparison, hazard ratio, detailed analysis plan, sample-size justification, or missing-data procedures. Serious adverse-event counts and selected event terms are posted, but the available information does not establish event attribution or comparative safety.