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 Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®. (NCT01652469), a randomized phase 3 study. The primary outcome is Progression-free Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01652469 |
| Phase | Phase 3 |
| Condition | Carcinoma, Non-Small-Cell Lung |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 81 |
| Arms in the primary outcome | 2 |
| Lead sponsor | ETOP IBCSG Partners Foundation |
| Results posted | Yes |
2. Clinical Question
Population
Patients with advanced squamous cell non-small cell lung cancer whose disease had failed first-line platinum-based doublet chemotherapy. Patients were classified by VeriStrat as VeriStrat Good or VeriStrat Poor before randomization. Further eligibility details are not reported in the registry record.
Intervention
Erlotinib, described as given at a standard dose until clinical or radiological progression, or unacceptable toxicity.
Comparator
Docetaxel, also described as given at a standard dose until clinical or radiological progression, or unacceptable toxicity.
Primary question
How did progression-free survival compare between the randomized erlotinib and docetaxel arms, and did the comparison differ according to VeriStrat Good versus VeriStrat Poor classification? The registry record reports arm-specific medians and confidence intervals, but does not report a treatment-by-VeriStrat interaction estimate or a hazard ratio for this comparison.
The trial’s central biomarker hypothesis was that VeriStrat classification could predict relative benefit from erlotinib versus docetaxel. The stated expectation was that VeriStrat Good patients treated with erlotinib would have improved progression-free survival, while VeriStrat Poor patients would not have a significant improvement with the same treatment. That statement describes the hypothesis, not a result. The posted primary outcome is reported by treatment arm, without the VeriStrat-stratum-specific estimates needed to assess the proposed difference in treatment effect.
The registry record identifies 81 as the enrollment figure. The posted primary outcome lists 38 participants for erlotinib and 42 for docetaxel. Those figures describe the outcome records and should not be treated as interchangeable with the enrollment figure. The record does not explain the difference in what those counts represent.
3. Trial Design
This was a randomized, phase III, parallel-group trial with no masking. It compared erlotinib with docetaxel in patients with advanced squamous cell non-small cell lung cancer after failure of first-line platinum-based doublet chemotherapy. VeriStrat testing classified patients as VeriStrat Good or VeriStrat Poor, and the trial description says patients were randomized between the treatment arms within those strata.
The intervention descriptions specify standard-dose erlotinib or standard-dose docetaxel. Both were to continue until clinical or radiological progression, or unacceptable toxicity. The registry record does not give dose amounts or further treatment-modification details. It names the ETOP IBCSG Partners Foundation as sponsor. The recorded status is completed. The recorded start is 2012-08, and primary completion is 2015-12.
The registry lists an enrollment of 81. For the primary outcome, the arm records list 38 for erlotinib and 42 for docetaxel. The record does not explain how enrollment relates to the arm-specific outcome counts, so these quantities should be kept distinct rather than combined or used to infer an analysis population.
Progression-free survival is the primary outcome. The record also lists overall survival, objective response, disease control, and participants with adverse events as secondary outcomes. It identifies five outcome measures and no analysis entries. The registry does not report allocation concealment, the randomization procedure, eligibility criteria beyond the disease and treatment history described, or details of the analysis population. The timeframe field says the combined run-in, treatment, and follow-up period for progression-free survival was expected to extend the study duration to a total of 24 months. This is a stated expectation, not a description of the observed follow-up for every participant.
Stratification matters to the trial’s stated purpose because the hypothesis concerns whether VeriStrat classification predicts differing treatment effects. Arm-level results alone describe the overall treatment groups; they do not show whether the hypothesized pattern appeared separately in the VeriStrat Good and VeriStrat Poor strata. Those stratum-specific primary outcome results are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | A: Erlotinib | B: Docetaxel |
|---|---|---|
| STARTED | 38 | 42 |
| COMPLETED | 37 | 36 |
| NOT COMPLETED | 1 | 6 |
Reasons for not completing this period:
| Reason | A: Erlotinib | B: Docetaxel |
|---|---|---|
| Withdrawal by Subject | 1 | 4 |
| Lost to Follow-up | 0 | 2 |
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 | A: Erlotinib | B: Docetaxel | Total |
|---|---|---|---|---|
| Participants analysed | 38 | 42 | 80 | |
| Age, Continuous | years | 66.7 (44.4 to 81.9) | 70.1 (53.3 to 84.0) | 68.7 (44.4 to 84.0) |
| Sex: Female, Male: Female | Participants | 7 | 7 | 14 |
| Sex: Female, Male: Male | Participants | 31 | 35 | 66 |
| Smoking history: Current | Participants | 16 | 12 | 28 |
| Smoking history: Former (>100 cigarettes & >12 months smoke-free) | Participants | 20 | 28 | 48 |
| Smoking history: Never | Participants | 2 | 2 | 4 |
| ECOG performance status: 0 | Participants | 12 | 15 | 27 |
| ECOG performance status: 1 | Participants | 24 | 22 | 46 |
| ECOG performance status: 2 | Participants | 2 | 5 | 7 |
| VeriStrat status: Good | Participants | 28 | 30 | 58 |
| VeriStrat status: Poor | Participants | 10 | 12 | 22 |
6. Primary Endpoint
The registry lists the primary outcome as Progression-free Survival, measured over The combined run in period, treatment and follow-up for PFS is expected to extend the study duration to a total of 24 months..
| 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, measured in months. It is defined as the time from randomization until documented disease progression or death without documented progression. This endpoint combines disease worsening and death into a time-to-event outcome, so a participant’s follow-up ends when either qualifying event occurs.
Progression is assessed using RECIST v1.1 criteria as described in the registry record. For target lesions, progression includes an increase of at least 20% in the sum of diameters, relative to the smallest sum on study, together with an absolute increase of at least 5 mm. The appearance of new lesions also qualifies. For non-target lesions, the record describes unequivocal progression of existing disease; new lesions also qualify. The description emphasizes that progression in non-target disease must represent substantial overall worsening.
Progression-free survival is commonly used in oncology trials because it captures the time until progression or death, rather than relying only on whether a response occurred at a particular assessment. As a general statistical point, this time-to-event measure can incorporate follow-up of different lengths, provided the analysis accounts for participants whose event time is not observed during follow-up. The registry does not report the specific censoring rules or analysis procedures used for this outcome.
The posted summaries are medians with 95% confidence intervals. A median describes the time by which half of the analyzed group has experienced the event, subject to the trial’s event and censoring definitions. It is not the average time without progression, and it does not by itself describe the full pattern of event times. The registry does not report a median follow-up duration.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted median progression-free survival is 1.6 months for erlotinib, with a 95% confidence interval from 1.3 to 3.8 months. For docetaxel, the posted median is 3.0 months, with a 95% confidence interval from 1.9 to 4.2 months. These are descriptive summaries of the recorded treatment arms. The intervals communicate uncertainty around each median; they are not ranges containing every participant’s progression-free survival time.
The intervals overlap. That visual fact does not establish that the treatments are equivalent, nor does it by itself establish whether a treatment difference is statistically significant. A formal between-arm inference would require an appropriate comparison estimate and its uncertainty, such as a hazard ratio with a confidence interval, or a reported test result under a specified analysis. Such a comparison result is not reported in the registry record. The primary outcome is marked as a median-time endpoint, and the registry record does not provide a hazard ratio for the arm comparison.
The treatment-by-VeriStrat question is more specific than the overall arm comparison. The trial hypothesis predicts a different relative treatment effect in VeriStrat Good and VeriStrat Poor patients. To assess that claim, stratum-specific estimates and a direct test or estimate of interaction are needed. The registry record gives no such estimates. Consequently, the posted arm-level medians cannot establish whether VeriStrat predicts treatment benefit, whether the hypothesized pattern occurred, or whether any apparent difference between strata is larger than chance variation.
The confidence intervals are wide enough to reflect uncertainty in the median estimates, particularly when interpreting the results for individual patients or as precise predictions. General statistical interpretation: a confidence interval represents uncertainty in an estimated quantity under the assumptions of the analysis. It is not a guarantee that the true value lies in the interval, and it does not quantify the range of individual outcomes.
The outcome counts are 38 for erlotinib and 42 for docetaxel. These are the counts attached to the posted primary outcome, while the registry’s enrollment figure is 81. Because the record does not reconcile these figures or report an analysis population, it is not possible to infer from them how many participants contributed to each part of the analysis or why the counts differ.
The registry lists secondary outcomes, but the results in this record do not include their estimates. In particular, the existence of an outcome listing is not evidence of a result. Nor should the stated trial hypothesis be read as a conclusion. On the information reported, the primary endpoint can be described by its arm-specific medians and confidence intervals, but the comparative statistical evidence and biomarker-stratum conclusion remain unreported.
9. Statistical Methods Explained
The primary outcome is a time-to-event measure. For each participant, the event is documented progression or death without documented progression, whichever occurs first under the stated definition. A median time-to-event estimate describes the point at which the estimated event experience reaches the halfway mark. It does not mean that all participants experienced the event at that time, and it does not summarize the distribution as fully as a curve or a treatment-effect estimate would.
The registry reports a median and a 95% confidence interval for each arm. In general, a confidence interval describes the statistical uncertainty around an estimate under the method and assumptions used to calculate it. A narrower interval generally indicates greater precision, while a wider interval indicates less precision. The intervals do not show the individual range of participant outcomes. The registry record does not identify the method used to calculate these confidence intervals, so no particular method should be attributed to the analysis.
Comparing medians is not the only way to analyze time-to-event data. A common comparative measure is the hazard ratio, which summarizes the relative event rate over follow-up under a model. This is a general explanation, not a result from this trial. A hazard ratio is not the ratio of the posted medians, and it cannot be derived reliably from the medians and confidence intervals alone. The registry record does not report a hazard ratio for the primary comparison. It also does not report a formal test result for the overall arm comparison.
Time-to-event analyses commonly account for participants whose event has not been observed by the end of their available follow-up. Such observations are generally treated as censored at the last time they are known to be event-free. This is a general description of the concept, not a claim about the trial’s exact handling of follow-up. The registry does not report the censoring rules, the analysis method, or the assumptions used for the primary endpoint. Those details matter because time-to-event estimates depend on how event timing and incomplete follow-up are handled.
The endpoint’s progression definition uses RECIST v1.1. The record describes target-lesion progression as a relative increase of at least 20% in the sum of diameters from the smallest sum on study, along with an absolute increase of at least 5 mm. New lesions also count as progression. For non-target lesions, progression is described as unequivocal worsening, and new lesions qualify as well. These criteria define the event; they do not by themselves specify when assessments were scheduled or how missing assessments were treated. Assessment frequency and missing-assessment rules are not reported in the registry record.
The main statistical issue raised by the trial’s stated hypothesis is effect modification. A predictive biomarker claim asks whether the relative effect of treatment differs between biomarker-defined groups. Finding an association between VeriStrat category and outcome in one arm would not, on its own, show that the category predicts which treatment is preferable. The relevant analysis compares treatment effects across the VeriStrat Good and VeriStrat Poor strata, typically through a treatment-by-stratum interaction. This is a general explanation. The registry does not report the stratum-specific progression-free survival estimates or an interaction result, so that question cannot be assessed from the posted primary outcome summaries.
Confidence intervals for arm-specific medians also should not be used as a substitute for an interaction analysis. Overlap or non-overlap between separate intervals is not the same as a formal test of a difference between treatment effects, and it says even less about whether those effects differ across biomarker strata. A direct comparative estimate with its uncertainty is needed for those claims. The record’s posted values permit description of the medians and their precision, but not reconstruction of an unreported comparison.
Sample-size calculations are planning tools, not evidence about the observed treatment effect. A planning illustration based on an observed effect does not establish what the trial was designed to detect, and it is not observed power. The registry record does not report the trial’s sample-size justification or statistical power assumptions. The record also does not report an interim-analysis plan or a statistical analysis plan. Those omissions prevent readers from checking whether the analysis followed prespecified procedures or how the study’s precision was expected to develop.
The registry contains no analysis entries, and it does not describe the model used for the primary comparison. The arm-specific medians and confidence intervals should therefore be read as the reported descriptive outcome summaries, not as a complete account of the trial’s statistical analysis. No adjusted or unadjusted comparison should be inferred where none is reported. Any calculation from the medians alone would not recover the event-time data or the sponsor’s analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists progression-free survival as the primary outcome and names overall survival, objective response, disease control, and participants with adverse events as secondary outcomes. Listing several outcomes raises the general issue of multiplicity: the more hypotheses assessed, the greater the chance that at least one result may appear unusual by chance if each is judged separately. This is a general statistical concern, not a claim that the trial made a particular multiplicity adjustment.
The registry record does not report a testing hierarchy, multiplicity adjustment, prespecified analysis plan, or results for the listed secondary outcomes. It also does not report how the primary endpoint was analyzed within the VeriStrat Good and VeriStrat Poor strata, or whether the biomarker hypothesis was treated as a confirmatory interaction test. Without those details, the status and interpretation of multiple comparisons cannot be determined.
Missing-data handling and analysis populations are also not described. The registry provides an enrollment figure of 81 and primary-outcome counts of 38 for erlotinib and 42 for docetaxel, but does not explain their relationship. It does not identify an intention-to-treat population, a per-protocol population, exclusions from analysis, reasons for missing outcome information, or how missing assessments were handled. These details are not reported in the registry record.
For a time-to-event endpoint, incomplete follow-up is not necessarily handled in the same way as a missing measurement at a scheduled visit. As a general point, censoring rules and assumptions affect interpretation of time-to-event estimates. The registry does not report those rules. The available record therefore supports a description of the posted arm-specific medians and intervals, but not a full evaluation of missing-data methods, analysis populations, or multiplicity control.
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 |
|---|---|---|---|
| A: Erlotinib | 7 | 38 | 18.4% |
| B: Docetaxel | 19 | 41 | 46.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| A: Erlotinib | 7 of 38 |
| B: Docetaxel | 3 of 41 |
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 |
|---|---|
| A: Erlotinib | 36 of 38 |
| B: Docetaxel | 39 of 41 |
Most frequent serious adverse event terms
| Event term | Organ system | A: Erlotinib | B: Docetaxel |
|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | 0 of 38 | 6 of 41 |
| Lung infection | Infections and infestations | 2 of 38 | 2 of 41 |
| Bronchial infection | Infections and infestations | 1 of 38 | 2 of 41 |
| Abdominal pain | Gastrointestinal disorders | 0 of 38 | 1 of 41 |
| Acidosis | Metabolism and nutrition disorders | 0 of 38 | 1 of 41 |
| Atrial flutter | Cardiac disorders | 0 of 38 | 1 of 41 |
| Back pain | Musculoskeletal and connective tissue disorders | 1 of 38 | 0 of 41 |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | 0 of 38 | 1 of 41 |
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | 1 of 38 | 0 of 41 |
| Cardiac arrest | Cardiac disorders | 0 of 38 | 1 of 41 |
Most frequent non-serious adverse event terms
| Event term | Organ system | A: Erlotinib | B: Docetaxel |
|---|---|---|---|
| Fatigue | General disorders | 11 of 38 | 24 of 41 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 16 of 38 | 13 of 41 |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 27 of 38 | 1 of 41 |
| Cough | Respiratory, thoracic and mediastinal disorders | 10 of 38 | 14 of 41 |
| Diarrhea | Gastrointestinal disorders | 10 of 38 | 11 of 41 |
| Anorexia | Metabolism and nutrition disorders | 7 of 38 | 8 of 41 |
| Neutrophil count decreased | Investigations | 2 of 38 | 12 of 41 |
| Mucositis oral | Gastrointestinal disorders | 5 of 38 | 9 of 41 |
| Nausea | Gastrointestinal disorders | 4 of 38 | 10 of 41 |
| Alopecia | Skin and subcutaneous tissue disorders | 1 of 38 | 11 of 41 |
Serious events with the highest arm-level rate: febrile neutropenia (14.6%), lung infection (5.3%), bronchial infection (4.9%), back pain (2.6%), bronchopulmonary hemorrhage (2.6%).
The registry lists serious adverse event counts of 7 for erlotinib and 19 for docetaxel. The corresponding serious-event at-risk counts are 38 and 41. The record also lists 36 and 39 participants, respectively, with other adverse events, using at-risk counts of 38 and 41. Death counts are 7 for erlotinib and 3 for docetaxel. These categories are reported separately; they should not be added together or treated as mutually exclusive without further information.
The listed serious-event terms include febrile neutropenia at 14.6%, lung infection at 5.3%, bronchial infection at 4.9%, back pain at 2.6%, bronchopulmonary hemorrhage at 2.6%, and hip fracture at 2.6%. The registry does not clarify in this record the exact denominator or counting convention used for each term. These percentages should therefore be read as registry-listed values, not recalculated or interpreted as participant-level risks beyond the definitions and denominators explicitly reported.
Safety counts describe events recorded in the trial. They do not, by themselves, establish that a treatment caused an event or permit a complete comparison of safety profiles. Interpretation also depends on event definitions, observation time, repeated events, and the population included in safety reporting; those details are not reported in the registry record. Death counts are not identified as treatment-related deaths in the record, so they should not be characterized as such.
12. What the Result Does, and Does Not, Mean
The registry record documents a randomized phase III comparison of erlotinib and docetaxel and reports arm-specific median progression-free survival estimates with 95% confidence intervals. Those estimates describe the posted outcome summaries: 1.6 months for erlotinib and 3.0 months for docetaxel. The intervals express uncertainty around those medians, rather than a range of individual outcomes.
The posted summaries do not include a hazard ratio, a formal comparative test, or another direct estimate of the treatment contrast. They also do not include progression-free survival results by VeriStrat group. As a result, the record does not establish the size or precision of a treatment effect, and it does not answer the central predictive-biomarker question about whether treatment effects differ for VeriStrat Good and VeriStrat Poor patients. The hypothesis in the trial description should not be mistaken for an observed conclusion.
The record also does not give results for the listed secondary outcomes, describe the statistical analysis plan, or explain the analysis population and the difference between enrollment and arm-specific outcome counts. These gaps limit what can be inferred from the registry entry. In particular, the available summaries should not be used to claim equivalence, superiority, or a lack of effect.
General statistical interpretation: an estimate is most informative when accompanied by a clear definition, a direct comparison, and a measure of uncertainty. The posted medians and confidence intervals offer information about each arm separately, but they are not a substitute for a comparative analysis. The evidence in the registry record is therefore descriptive and incomplete for the trial’s principal comparative and biomarker questions.
These results do not establish what an individual patient’s outcome would be, and they do not support treatment advice. They describe the registry’s reported trial outcomes and the limits of the information available in that record.
13. Why This Trial Matters Statistically
This trial raises a statistically important distinction between a prognostic marker and a predictive marker. A prognostic marker is associated with outcome regardless of treatment, while a predictive marker identifies variation in the relative effect of different treatments. The trial’s stated hypothesis concerns prediction: VeriStrat classification was proposed as a way to identify groups with different relative progression-free survival under erlotinib versus docetaxel. Demonstrating that claim requires a direct comparison of treatment effects across the VeriStrat strata, not simply separate descriptions of outcomes.
The registry record makes the distinction especially relevant because it reports overall arm-specific medians but not stratum-specific estimates or an interaction result. The posted numbers can describe progression-free survival in each treatment arm as recorded, but they cannot establish whether biomarker classification modified the treatment effect. This illustrates why a trial’s scientific question and its available results must be considered separately.
The endpoint also illustrates a core feature of clinical-trial statistics: time-to-event outcomes include both event timing and incomplete follow-up. Medians and confidence intervals communicate some information about the time scale and precision, but a full comparison usually depends on an explicit analysis of event-time data. Without a reported comparative estimate and analysis details, arm-level summaries alone cannot settle the comparative question.
Finally, the record identifies multiple secondary outcomes but does not report their results or a multiplicity strategy. That makes it important to distinguish the primary outcome from the wider set of questions listed in a trial registry. Transparent reporting of analysis populations, missing-data methods, prespecified comparisons, and uncertainty would help readers judge how far the evidence supports the planned questions.
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.
The registry record reports the primary outcome as arm-specific medians and confidence intervals, but does not report a hazard ratio, formal test, or other direct treatment-comparison estimate. It also does not report progression-free survival estimates separately for VeriStrat Good and VeriStrat Poor patients. Because the trial’s stated purpose includes a predictive-biomarker hypothesis, the absence of these results is a central limitation for interpreting that question.
The primary-outcome counts differ from the enrollment figure, and the record does not explain how enrollment relates to the arm-specific counts. The analysis population, exclusions, and reasons for absent outcome data are not reported. Follow-up duration by participant, censoring rules, assessment schedule, and handling of missing assessments are also not described. These omissions limit evaluation of the precision and potential sources of bias in the time-to-event summaries.
The registry does not report a statistical analysis plan, sample-size justification, interim-analysis plan, or the method used to calculate the confidence intervals. It lists secondary outcomes but does not provide their results or describe any approach to multiplicity. Consequently, the record does not allow a full assessment of prespecification, analysis choices, or the evidential status of secondary comparisons.
The safety record gives event counts and at-risk counts, along with selected serious-event terms and percentages, but does not specify all counting conventions or exposure-time details. The counts therefore do not alone establish comparative event risks or causation. These limitations apply to interpretation of this registry record and should not be filled in by assumptions about customary trial procedures.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®. — NCT01652469.
- Registry record last updated 2026-08-26; status last verified 2022-08.
- Results first posted 2019-08-08.
- 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
NCT01652469 is a completed randomized phase III trial comparing erlotinib with docetaxel in advanced squamous cell non-small cell lung cancer after failure of first-line platinum-based doublet chemotherapy. Patients were classified as VeriStrat Good or VeriStrat Poor, and the trial hypothesis concerned whether that classification predicted relative treatment benefit.
The primary outcome was progression-free survival, defined as time from randomization to documented progression or death without documented progression. The posted medians are 1.6 months for erlotinib and 3.0 months for docetaxel, with 95% confidence intervals of 1.3 to 3.8 months and 1.9 to 4.2 months, respectively. The record does not report a hazard ratio or formal comparison result, nor does it report outcome estimates by VeriStrat stratum.
The registry lists overall survival, objective response, disease control, and adverse events as secondary outcomes. Analysis methods, analysis populations, missing-data handling, and multiplicity procedures are not reported in the registry record.