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 Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor (NCT00085202), a non-randomized phase 3 study. The primary outcome is Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00085202 |
| Phase | Phase 3 |
| Condition | Brain and Central Nervous System Tumors |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 416 |
| Arms in the primary outcome | n/a |
| Lead sponsor | St. Jude Children's Research Hospital |
| Results posted | Yes |
2. Clinical Question
Population
The trial enrolled patients with newly diagnosed medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor. The primary analysis was narrower: it included the first 122 participants with medulloblastoma who had fresh tissue and ERBB2 protein assessments. Patients with PNET, PNET variants, or ATRT were not included in that analysis.
Intervention
The trial studied treatment regimens combining radiation therapy with chemotherapy and autologous hematopoietic stem cell transplantation. The registry describes average-risk and high-risk groups with different radiation doses, alongside high-dose chemotherapy, transplantation, filgrastim, and post-transplantation vincristine. The available description is incomplete for some treatment details.
Comparator
The study is listed as non-randomized, with a parallel model and no masking. Its risk groups are not randomized comparison arms, and the registry record does not establish a like-for-like control comparison. The primary analysis compared progression-free survival distributions according to tumor ERBB2 status, rather than comparing randomized treatment assignments.
Primary question
Among participants with medulloblastoma and ERBB2 protein assessments, was ERBB2 status associated with progression-free survival? ERBB2 values greater than zero were defined as positive; a value of zero was defined as negative. The registry describes the outcome as probability of progression-free survival at 2 years and specifies a log-rank comparison of the groups’ progression-free survival distributions. The estimates and comparison result are not reported in the registry record.
3. Trial Design
This was a phase III, non-randomized, unmasked, parallel study sponsored by St. Jude Children's Research Hospital. The registry lists enrollment of 416 and a completed status. The recorded start was 2003-08, and primary completion was 2016-12. Its broad treatment question concerned radiation therapy regimens given with chemotherapy and autologous stem cell transplantation for patients with newly diagnosed medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor.
The treatment descriptions distinguish an average-risk group from a high-risk group. For the high-risk group, the registry describes craniospinal radiotherapy once daily, 5 days a week, for 6 weeks, followed by high-dose chemotherapy, autologous stem cell transplantation, filgrastim, and post-transplantation vincristine. The average-risk description says craniospinal radiotherapy was given at a lower dose, followed by high-dose chemotherapy, autologous transplantation, G-CSF, and post-transplantation vincristine. Some arm-description text is incomplete, so further regimen details are not reported in the registry record.
The non-randomized allocation is important to interpretation. Assignment procedures and the reasons for risk-group membership are not reported in the registry record. The risk groups therefore cannot be treated as randomized arms, and observed differences between them could not be attributed to treatment alone from this design. The registry's main posted analysis instead concerns ERBB2 status and progression-free survival in a selected medulloblastoma subset. The record does not describe a randomized comparison of ERBB2 groups; ERBB2 is a tumor characteristic, not a treatment assignment.
The broad enrollment figure and the primary-analysis population describe different populations. The primary analysis included the first 122 participants with medulloblastoma, fresh tissue, and ERBB2 protein assessments, excluding PNET, PNET variants, and ATRT. Why this subset was selected, beyond the stated analysis criteria, is 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.
Before assignment: Of the 416 participants enrolled, three were ineligible and taken off study.
Overall Study
| Stage | Average-Risk Group | High-Risk Group |
|---|---|---|
| STARTED | 269 | 144 |
| COMPLETED | 251 | 120 |
| NOT COMPLETED | 18 | 24 |
Reasons for not completing this period:
| Reason | Average-Risk Group | High-Risk Group |
|---|---|---|
| Still on therapy | 2 | 0 |
| Bone involvement confirmed by bone scan | 0 | 1 |
| Excessive toxicity | 6 | 5 |
| Non-specified | 3 | 5 |
| Withdrawal by Subject | 2 | 1 |
| Physician Decision | 4 | 1 |
| Progressive disease | 1 | 11 |
Analysis population for the primary outcome, as defined in the registry: Analysis included the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of PNET, PNET variants, or ATRT were not included in this analysis.
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.
Population: Participants had a diagnosis of medulloblastoma, supratentorial primitive neuroectodermal tumor (PNET), PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma), or atypical teratoid rhabdoid tumor (ATRT).
| Characteristic | Unit | Average-Risk Group | High-Risk Group | Total |
|---|---|---|---|---|
| Participants analysed | 269 | 144 | 413 | |
| Age, Continuous | Years | 9.15 (SD 4.08) | 8.66 (SD 3.93) | 8.98 (SD 4.03) |
| Age, Continuous | years | 8.42 (3.06 to 21.56) | 7.87 (3.13 to 20.43) | 8.33 (3.06 to 21.56) |
| Sex: Female, Male: Female | Participants | 105 | 56 | 161 |
| Sex: Female, Male: Male | Participants | 164 | 88 | 252 |
6. Primary Endpoint
The registry lists the primary outcome as Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors, measured over 2 years after tumor cell analysis in 122 participants.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | probability of PFS at 2 years |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is described as probability of progression-free survival at 2 years, comparing ERBB2-negative and ERBB2-positive tumors. The registry defines progression-free survival from diagnosis until disease progression or relapse, death, or the date of last contact. ERBB2 status was defined using the protein assessment: a value greater than zero counted as positive, while a value of zero counted as negative.
Progression-free survival is a time-to-event outcome. In general, it captures how long participants remain alive without the event specified in the definition, and it can account for participants whose follow-up ends before an event is observed. Here, the listed event definition includes progression or relapse and death. The record describes the endpoint timeframe as 2 years after tumor cell analysis in 122 participants, while its endpoint definition measures time from diagnosis. These descriptions are both retained in the record; further clarification is not reported.
The endpoint is relevant to the stated biomarker question because it relates tumor ERBB2 status to the timing of progression, relapse, or death. It does not, by itself, establish that ERBB2 status causes a difference in outcome or that a treatment regimen caused any observed difference. The registry gives a 95% confidence-interval measure and specifies a log-rank test, but the group estimates, confidence limits, and test result are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary posted question is an association between ERBB2 protein status and progression-free survival among participants with medulloblastoma. The analysis population was the first 122 participants with fresh tissue and ERBB2 assessments. Participants with PNET, PNET variants, or ATRT were excluded. The stated definitions classify any ERBB2 value greater than zero as positive and a value of zero as negative.
The registry identifies probability of progression-free survival at 2 years as the outcome and says that the log-rank test was used to compare the progression-free survival distributions of the ERBB2 groups. However, it does not report the probability estimates, confidence interval limits, or log-rank test result in the posted outcome information. Consequently, the direction and magnitude of any observed association, and the precision of any estimated difference, are not reported in the registry record. No conclusion about whether the groups had similar or different outcomes can be drawn from the information recorded.
In general, an estimate describes the observed outcome in the analyzed participants, while its confidence interval conveys uncertainty around that estimate under the method used. A confidence interval is not a guarantee that the true value lies within a particular range. In this record, the dispersion measure is identified as a 95% confidence interval, but the actual interval is absent. The registry’s specified statistical test is also named without its result. Naming a test does not substitute for reporting the test statistic, p-value, or other result that would allow readers to assess the evidence in the analyzed data.
This is not a randomized comparison of treatment regimens. The trial is listed as non-randomized, and the average-risk and high-risk groups are not like-for-like control groups. The primary analysis compares tumor biomarker categories, not assigned treatment strategies. Even if an association estimate were available, differences between biomarker groups could reflect other characteristics as well as ERBB2 status; adjustment procedures and a full analysis plan are not reported in the registry record.
The registry also lists 11 outcome measures and 6 analyses. How the analyses relate to one another, whether any were designated as primary or exploratory beyond the described primary objective, and whether a multiplicity adjustment was used are not reported in the registry record. The stated sample-size planning assumptions describe illustrations based on an observed effect, rather than the trial's own design justification. The registry's sample-size justification is not reported. These planning illustrations should not be read as observed power or as a substitute for the missing outcome estimates.
9. Statistical Methods Explained
The methods described in the registry address a time-to-event endpoint and a biomarker-group comparison. The information identifies the endpoint definition, ERBB2 classification rule, analyzed population, and log-rank test. It does not give the numerical results or a complete statistical analysis plan.
What does progression-free survival measure?
Progression-free survival measures time from a specified starting point until a defined event. In this analysis, the registry says the clock begins at diagnosis and the event is disease progression or relapse, or death. The date of last contact is also named in the definition, which allows follow-up to end for participants without a recorded event. In general, this kind of observation is called censoring: the participant contributes information up to the last known follow-up, but the exact later event time is unknown. The specific censoring rules and details of follow-up are not reported in the registry record.
The registry describes the outcome as probability of progression-free survival at 2 years after tumor cell analysis in 122 participants, while the time-to-event definition starts at diagnosis. A fixed-time probability and a full time-to-event distribution are related but not identical summaries. The record states both descriptions but does not explain how the stated timeframe relates to the diagnosis-based time origin. This distinction matters when interpreting the endpoint and comparing it with results that use another starting point.
How were ERBB2 groups defined?
ERBB2 protein expression was used to form the two biomarker groups. A value greater than zero was defined as positive, and a value of zero was defined as negative. This is a classification rule, not a claim that the groups differ in treatment. The record does not state how the protein value was measured, whether the assessment was repeated, how borderline or unavailable measurements were handled, or whether the threshold was chosen before the analysis.
The analyzed population included the first 122 participants with a medulloblastoma diagnosis, fresh tissue, and ERBB2 protein assessment. Diagnoses of PNET, PNET variants, and ATRT were excluded from this analysis. These criteria identify who was included, but do not establish whether those participants represent all enrolled patients with medulloblastoma. The selection process and reasons for unavailable tissue or assessments are not reported in the registry record.
What does the log-rank test do?
The registry says the log-rank test was used to compare progression-free survival distributions between ERBB2 groups. In general, this test compares the timing of events across groups over follow-up, accounting for participants who have not had an event by their last observation. It is not simply a comparison of the two groups’ percentages at one particular time point. The test result, p-value, and any assumptions checks are not reported in the registry record.
A log-rank comparison is an unadjusted comparison unless an adjusted method is separately specified. The registry record does not report an adjusted model or covariates for this analysis. It also does not report whether proportional hazards were assessed, whether a hazard ratio was estimated, or whether other time-to-event methods were used. Those methods should not be presumed from the mention of a log-rank test.
How should the confidence interval be understood?
The dispersion measure is identified as a 95% confidence interval. In general, a confidence interval expresses uncertainty in an estimate under the statistical method and assumptions used. A narrower interval usually indicates greater precision than a wider interval, while an interval that spans a broad range allows less precise conclusions. The actual interval limits for the ERBB2 groups are not reported in the registry record, so the precision of their estimated progression-free survival cannot be assessed from the posted outcome information. The registry does not specify the method used to calculate those intervals.
What do the planning assumptions describe?
The registry record's planning assumptions describe sample-size illustrations based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The assumptions distinguish time-to-event illustrations, which use a total event count, from other illustrations, which use participants per arm. These are planning illustrations, not evidence that the trial was designed using those assumptions, and they are not observed power. The trial's own sample-size justification and the calculations behind the illustrations are not reported in the registry record.
In general, a sample-size illustration estimates the amount of information that might be needed to detect a specified effect under selected assumptions. Its relevance depends on whether those assumptions match the actual design, analysis, and outcome. Here, the trial is non-randomized, and the primary analysis is a biomarker-group comparison in a subset; the planning assumptions refer to equal allocation between two arms. The registry does not explain how those illustrations map to the primary biomarker analysis or the broader trial design.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 11 outcome measures and 6 analyses. They include the ERBB2 and progression-free survival outcome as well as secondary outcomes concerning reading, treatment failure location, associative memory, processing speed, and perceptual speed. Some listed measures refer to different risk groups or assessment times. The record does not specify a hierarchy for all outcomes and analyses, or indicate which were confirmatory and which were exploratory.
Multiplicity arises when several outcomes, groups, time points, or statistical tests are examined. In general, the more comparisons made, the greater the opportunity for apparently unusual results to occur by chance. Statistical plans may address this with prespecified priorities or adjustment methods. Whether any such approach was used is not reported in the registry record, so the listed analyses should not be assumed to have been adjusted for multiple testing.
The primary analysis population is described as the first 122 participants with medulloblastoma, fresh tissue, and ERBB2 protein assessments. PNET, PNET variants, and ATRT were excluded. This identifies an analysis subset, but missing-data procedures are not reported in the registry record. The record does not say how missing ERBB2 assessments, unavailable fresh tissue, incomplete follow-up, or missing outcome information were handled, or whether sensitivity analyses were conducted.
The analysis population for each secondary outcome and the handling of participants who did not complete later assessments are also not reported in the registry record. The record does not provide a complete account of analysis populations, outcome-specific denominators, or imputation methods. These omissions limit assessment of whether the analyzed participants and available follow-up could affect the reported results.
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 |
|---|---|---|---|
| Average-Risk Group | 17 | 269 | 6.3% |
| High-Risk Group | 17 | 144 | 11.8% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Average-Risk Group | 236 of 269 |
| High-Risk Group | 118 of 144 |
Most frequent serious adverse event terms
| Event term | Organ system | Average-Risk Group | High-Risk Group |
|---|---|---|---|
| Seizure | Nervous system disorders | 3 of 269 | 3 of 144 |
| CNS necrosis/cystic progression | Nervous system disorders | 1 of 269 | 3 of 144 |
| Febrile neutropenia | Infections and infestations | 2 of 269 | 0 of 144 |
| Infection with normal ANC or Grade 1 or 2 neutrophils, blood | Infections and infestations | 0 of 269 | 2 of 144 |
| Infection with unknown ANC, meninges (meningitis) | Infections and infestations | 2 of 269 | 0 of 144 |
| Leak, cerebrospinal fluid (CSF) | Nervous system disorders | 0 of 269 | 2 of 144 |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | 2 of 269 | 0 of 144 |
| Pulmonary/upper respiratory - other | Respiratory, thoracic and mediastinal disorders | 1 of 269 | 1 of 144 |
| Syndromes - other | General disorders | 1 of 269 | 1 of 144 |
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | 1 of 269 | 0 of 144 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Average-Risk Group | High-Risk Group |
|---|---|---|---|
| Febrile neutropenia | Infections and infestations | 172 of 269 | 77 of 144 |
| Infection, blood | Infections and infestations | 55 of 269 | 24 of 144 |
| Vomiting | Gastrointestinal disorders | 53 of 269 | 21 of 144 |
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | 39 of 269 | 23 of 144 |
| Pain, abdomen NOS | General disorders | 33 of 269 | 17 of 144 |
| Nausea | Gastrointestinal disorders | 27 of 269 | 20 of 144 |
| Infection - other | Infections and infestations | 25 of 269 | 16 of 144 |
| Diarrhea | Gastrointestinal disorders | 23 of 269 | 14 of 144 |
| Infection with normal ANC or Grade 1 or 2 neutrophils, blood | Infections and infestations | 21 of 269 | 9 of 144 |
| Infection with unknown ANC, blood | Infections and infestations | 17 of 269 | 13 of 144 |
Serious events with the highest arm-level rate: cns necrosis/cystic progression (2.1%), seizure (2.1%), infection with normal anc or grade 1 or 2 neutrophils, blood (1.4%), leak, cerebrospinal fluid (csf) (1.4%), febrile neutropenia (0.7%).
The registry lists serious adverse event information separately for the average-risk and high-risk groups. For the average-risk group, it lists 269 at risk and 17 affected for serious events; for other events, it lists 269 at risk and 236 affected. For the high-risk group, the corresponding figures are 144 at risk and 17 affected for serious events, and 144 at risk and 118 affected for other events. These are the recorded counts, not a randomized comparison between groups. The registry record does not provide an explanation of the event-counting rules or enough detail to establish that the groups are directly comparable.
The serious-event terms listed include CNS necrosis/cystic progression and seizure, each at 2.1%; infection with normal ANC or Grade 1 or 2 neutrophils, blood, and leak, cerebrospinal fluid (CSF), each at 1.4%; and febrile neutropenia and infection with unknown ANC, meninges (meningitis), each at 0.7%. These percentages are presented as listed in the registry. The record does not identify the denominator or provide additional context for interpreting each percentage.
Counts and listed terms describe recorded events, not whether an event was caused by a treatment. Because allocation was non-randomized and groups had different numbers at risk, simple comparisons between their counts would be misleading. The registry record does not report deaths in these group fields.
12. What the Result Does, and Does Not, Mean
The posted information establishes that a phase III, non-randomized, parallel study examined treatment regimens for newly diagnosed medulloblastoma, supratentorial primitive neuroectodermal tumor, and atypical teratoid rhabdoid tumor. It also establishes that the primary posted analysis concerned the association between ERBB2 protein status and progression-free survival in a selected medulloblastoma population. The outcome definition and ERBB2 classification rule are described, and the log-rank test is named.
What the record does not establish is the numerical result of that biomarker analysis. The progression-free survival estimates, confidence interval limits, and test result are not reported in the registry record. Without those results, the direction, magnitude, and precision of any association cannot be determined from the posted information. The stated test method alone does not show whether the groups differed.
This analysis is not evidence from a randomized comparison of ERBB2 groups or of the average-risk and high-risk treatment regimens. ERBB2 status was a tumor characteristic, while the study is listed as non-randomized. The record does not describe adjustment for other participant or disease characteristics, so a biomarker association, if present in the underlying data, would not by itself demonstrate a causal effect of ERBB2 or a treatment effect.
The serious adverse event counts and selected event percentages describe what the registry lists for the risk groups. They do not establish that any event was caused by a particular treatment, and the non-randomized design limits direct comparisons. The registry record also does not report an explanation of the event-counting rules or the denominator for the listed serious-event percentages.
Overall, the registry permits readers to identify the clinical setting, broad study structure, primary biomarker question, and some safety counts. It does not supply the outcome estimates needed to judge the primary association, nor does it report enough analysis-plan detail to resolve questions about missing data, multiplicity, or adjustment. No conclusion about treatment benefit or lack of benefit follows from the information recorded.
13. Why This Trial Matters Statistically
This trial raises several statistical issues that are common in clinical research. Its overall enrollment of 416 concerns a broad set of diagnoses, while the primary posted analysis concerns the first 122 participants with medulloblastoma, fresh tissue, and ERBB2 protein assessments. Distinguishing the enrolled population from the population contributing to a particular analysis is essential: a result in a selected subset does not automatically describe every enrolled diagnosis or participant.
The study also illustrates why design labels matter. A phase III designation does not make a study randomized. This record identifies non-randomized allocation and distinguishes average-risk and high-risk groups. Those groups are not a like-for-like control comparison, and observed differences cannot be interpreted as treatment effects without considering how participants entered each group and what else differed between them. The relevant assignment details are not reported in the registry record.
The primary objective is framed around a tumor biomarker and a time-to-event outcome. The registry defines ERBB2 categories and progression-free survival, and names a log-rank test. Yet the estimates and test result are absent from the posted information. This highlights an important reporting principle: naming a statistical method is not enough to communicate what the data showed. Effect estimates and their uncertainty are needed to judge both the direction and precision of an association.
Finally, the record lists multiple outcomes and analyses, along with a selected set of serious adverse event terms. Without a reported multiplicity strategy, missing-data approach, and complete analysis populations, readers cannot fully assess how those findings were generated. Clear reporting of populations, endpoints, methods, uncertainty, and limitations is as important as the headline design and enrollment information.
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 primary analysis is restricted to participants with medulloblastoma who had fresh tissue and ERBB2 protein assessments, and the registry describes it as including the first 122 participants meeting those criteria. Participants with PNET, PNET variants, or ATRT were excluded. The registry record does not report how many otherwise eligible participants lacked tissue or ERBB2 assessment, why those data were unavailable, or whether the selected subset differed from other enrolled participants.
The primary outcome description contains two time references: the timeframe is stated as 2 years after tumor cell analysis, while progression-free survival is defined from diagnosis. The registry does not clarify the relationship between those time origins. It also does not report the estimates, confidence interval limits, or log-rank result, leaving the central biomarker comparison uninterpretable in terms of direction and precision.
The non-randomized design limits causal interpretation of comparisons between risk groups. The record does not describe allocation procedures, risk classification details, adjustment for prognostic factors, or reasons for group assignment. Some treatment-arm descriptions are incomplete, which further limits a full account of the regimens. No inference that a treatment caused an outcome difference is supported by the design description alone.
The registry lists multiple outcomes and analyses but does not report whether multiplicity was addressed. Missing-data methods, follow-up completeness, outcome-specific analysis populations, and sensitivity analyses are also not reported in the registry record. For serious adverse events, event-counting details and denominators for the listed percentages are not given. These gaps constrain assessment of the outcome and safety information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor — NCT00085202.
- Registry record last updated 2024-02-08; status last verified 2024-01.
- Results first posted 2014-02-27.
- 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 identifies a completed phase III, non-randomized, unmasked, parallel study sponsored by St. Jude Children's Research Hospital. Enrollment was 416. The recorded start was 2003-08, and primary completion was 2016-12. The trial studied treatment regimens involving radiation therapy, chemotherapy, and autologous hematopoietic stem cell transplantation in newly diagnosed medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor.
The primary posted analysis examined progression-free survival by tumor ERBB2 status in the first 122 participants with medulloblastoma, fresh tissue, and ERBB2 protein assessments. The registry defines ERBB2-positive as a value greater than zero and ERBB2-negative as zero, and names a log-rank test. Numerical estimates and test results are not reported in the registry record. The record also lists serious adverse event counts by risk group and selected event terms, but does not establish causal relationships or a randomized comparison.