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 Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma (NCT01231906), a randomized phase 3 study. The primary outcome is Event-Free Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01231906 |
| Phase | Phase 3 |
| Condition | Localized Extraskeletal Ewing Sarcoma, Peripheral Primitive Neuroectodermal Tumor of Bone, Peripheral Primitive Neuroectodermal Tumor of Soft Tissues |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 642 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Children's Oncology Group |
| Results posted | Yes |
2. Clinical Question
Population
Patients with non-metastatic extracranial Ewing sarcoma were eligible for study entry. The registry lists localized extraskeletal Ewing sarcoma and peripheral primitive neuroectodermal tumors of bone and soft tissues among the conditions studied. The primary endpoint calculation includes only eligible patients. Further details on the eligibility criteria and the characteristics of enrolled patients are not reported in the registry record.
Intervention
Arm B received standard chemotherapy with an additional vincristine, topotecan, and cyclophosphamide combination. The registry describes these drugs as part of an induction regimen. It also lists other chemotherapy drugs and laboratory biomarker analysis among the interventions. The full treatment schedules are not reproduced in the posted arm descriptions.
Comparator
Arm A received the established five-drug chemotherapy approach: vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide. The registry describes Arm B as receiving the same five drugs with an additional combination involving topotecan, vincristine, and cyclophosphamide. Thus, the comparison concerns adding a treatment combination to the standard approach, not comparing chemotherapy with no chemotherapy.
Primary question
The primary question was whether the estimated probability of event-free survival at five years differed between the two chemotherapy arms. An event was defined as disease progression, relapse, a second malignant neoplasm, or death from any cause. The registry posts an estimate for each arm, but does not report a direct between-arm estimate or test for this comparison.
3. Trial Design
This was a randomized, parallel-group phase III trial sponsored by the Children's Oncology Group. The registry describes the study as unmasked, meaning masking was not used. Patients were assigned to one of two chemotherapy approaches: the standard five-drug regimen in Arm A, or that approach with an added vincristine, topotecan, and cyclophosphamide combination in Arm B. The registry does not report the allocation ratio or further details about how randomization was implemented.
The trial enrolled 642 participants. The posted primary endpoint estimates are based on eligible patients, with 309 participants listed for Arm A and 320 for Arm B. These endpoint group counts should not be interpreted as a complete account of everyone enrolled or randomized: the primary outcome specifically uses eligible patients, and the registry does not explain the relationship between these counts and total enrollment.
The study started on 2010-11-24, had a primary completion date of 2020-03-31, and is marked completed. The registry title identifies the study as a trial of adding vincristine, topotecan, and cyclophosphamide to standard chemotherapy in initial treatment of non-metastatic Ewing sarcoma. Full eligibility criteria, treatment adherence, crossovers, and details of post-treatment care are not reported in the registry record. The arm descriptions are incomplete, so the full dosing schedules cannot be reconstructed from the posted record.
Randomization supports a planned comparison between treatment assignments, but it does not guarantee that all features of the groups are identical. Unmasked treatment assignment can also be relevant when considering outcome assessment and care. The registry does not report further information about these processes. The posted result is an estimate for each arm; no direct treatment contrast, adjusted analysis, or statistical test for the primary comparison is reported.
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 | Arm A (Combination Chemotherapy) | Arm B (Combination Chemotherapy, Topotecan Hydrochloride) |
|---|---|---|
| STARTED | 319 | 323 |
| Received Therapy | 308 | 318 |
| COMPLETED | 198 | 222 |
| NOT COMPLETED | 121 | 101 |
Reasons for not completing this period:
| Reason | Arm A (Combination Chemotherapy) | Arm B (Combination Chemotherapy, Topotecan Hydrochloride) |
|---|---|---|
| Lack of Efficacy | 75 | 68 |
| Lost to Follow-up | 1 | 0 |
| Physician Decision | 34 | 24 |
| Withdrawal by Subject | 0 | 4 |
| Ineligible | 10 | 3 |
| No treatment | 1 | 2 |
Analysis population for the primary outcome, as defined in the registry: Only eligible patients are considered in the calculation of this outcome measure.
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 | Arm A (Combination Chemotherapy) | Arm B (Combination Chemotherapy, Topotecan Hydrochloride) | Total |
|---|---|---|---|---|
| Participants analysed | 319 | 323 | 642 | |
| Age, Categorical: <=18 years | Participants | 272 | 280 | 552 |
| Age, Categorical: Between 18 and 65 years | Participants | 47 | 43 | 90 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 13 (0 to 32) | 13 (0 to 34) | 13 (0 to 34) |
| Sex: Female, Male: Female | Participants | 145 | 130 | 275 |
| Sex: Female, Male: Male | Participants | 174 | 193 | 367 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 45 | 44 | 89 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 269 | 275 | 544 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 5 | 4 | 9 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 3 | 3 |
| Race (NIH/OMB): Asian | Participants | 11 | 6 | 17 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 3 | 2 | 5 |
| Race (NIH/OMB): Black or African American | Participants | 10 | 4 | 14 |
| Race (NIH/OMB): White | Participants | 267 | 280 | 547 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 28 | 28 | 56 |
| Region of Enrollment: United States | Participants | 286 | 286 | 572 |
| Region of Enrollment: Australia | Participants | 17 | 20 | 37 |
| Region of Enrollment: Canada | Participants | 14 | 13 | 27 |
| Region of Enrollment: New Zealand | Participants | 2 | 2 | 4 |
| Region of Enrollment: Saudi Arabia | Participants | 0 | 2 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Event-Free Survival, measured over 5 years after enrollment.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | Percent Probability |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is event-free survival (EFS), estimated as a percentage probability at five years after enrollment. EFS measures the time from study enrollment until the first of disease progression, disease relapse, a second malignant neoplasm, death from any cause, or last follow-up. Patients without a recorded event are censored at last contact. The registry says the estimate uses the Kaplan-Meier method.
As a general statistical concept, a time-to-event endpoint uses both whether an event occurred and when it occurred. This is useful when participants may have different lengths of follow-up: those without a recorded event can contribute information up to their last contact rather than being treated as if their outcome were known indefinitely. Censoring indicates that the event time is not observed beyond that contact; it does not mean that an event occurred at that time.
The endpoint combines several kinds of events, including progression, relapse, a second malignancy, and death. Consequently, the EFS estimate is not a measure of any one of those outcomes in isolation. The registry does not report separate estimates for the individual event types as part of the posted primary result. It also does not describe the precision of estimates at time points other than the stated five-year assessment.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports estimated 5-year EFS of 77.64% for Arm A, with a 95% confidence interval from 72.42% to 81.99%. For Arm B, the estimate is 78.79%, with a 95% confidence interval from 73.7% to 83.01%. These are arm-specific Kaplan-Meier estimates among eligible patients, not raw proportions calculated by dividing events by the listed group counts.
As a general statistical concept, a confidence interval describes uncertainty around an estimate under the assumptions of the method. The intervals communicate that the estimates are not known with perfect precision. Their width reflects uncertainty, but the registry does not provide the event counts or other information needed to reconstruct the interval calculations independently. The posted estimates and intervals alone do not establish whether the arms differ statistically or clinically.
The registry does not report a direct estimate of the difference between arms, a confidence interval for that difference, or a p-value for the primary comparison. The separate arm estimates should therefore be read as descriptive results, not as a reported test of treatment effect. Comparing the endpoints of two separate confidence intervals is not a substitute for a confidence interval or test for the between-arm contrast. No adjusted comparison is reported either.
The primary endpoint population is described as eligible patients. The arm counts listed with the outcome are 309 for Arm A and 320 for Arm B. These counts are distinct from the overall enrollment of 642, and the record does not explain the difference. The endpoint result should not be generalized automatically to every enrolled participant without knowing how eligibility and analysis inclusion were determined.
The posted results also include serious adverse-event figures, other adverse-event figures, and deaths by arm. Those are separate safety summaries and do not explain the EFS result. The registry does not establish that every death listed in the safety data was an EFS event during the relevant follow-up period, nor whether safety counts overlap with other categories. Interpretation of the efficacy and safety summaries should remain within the definitions and populations recorded for each.
Overall, the record gives five-year estimates for both randomized arms but does not post the primary between-arm analysis. A conclusion about the size, precision, or statistical evidence for a treatment contrast cannot be drawn from these arm estimates alone. No claim that either regimen improves or fails to improve outcomes follows from the posted data without the missing comparative analysis.
9. Statistical Methods Explained
The registry identifies the primary endpoint as event-free survival and states that its five-year estimate was calculated using the Kaplan-Meier method. This is a time-to-event method: it uses the timing of events and accommodates participants whose event status is not observed for the full follow-up period by censoring them at last contact. The registry defines an event as progression, relapse, a second malignant neoplasm, or death from any cause.
What does a Kaplan-Meier estimate represent?
As a general statistical explanation, a Kaplan-Meier estimate describes the probability of remaining event-free over time, using the observed event times and the follow-up available before each time. Participants who are event-free at last contact are censored at that contact. Censoring preserves the information observed up to that point; it does not establish that a participant remained event-free after follow-up ended. Interpretation depends on the assumptions of the method, including that censoring does not create a systematically misleading picture of future event risk.
The posted result is expressed as a five-year percentage probability. The registry provides the estimate and a 95% confidence interval for each arm. It does not provide the event counts, numbers at risk over time, or a curve-specific set of estimates in the registry record stated for the primary outcome. Those details are not reported in the registry record, so they cannot be used to assess how much information remained at the five-year point or to reproduce the analysis.
How should the confidence intervals be read?
As a general statistical explanation, a confidence interval conveys uncertainty in an estimated quantity under the method used to calculate it. The interval for Arm A is 72.42% to 81.99%, and the interval for Arm B is 73.7% to 83.01%. These are intervals for separate arm estimates. They are not confidence intervals for the difference between arms, and they do not themselves provide a formal test of that difference. The registry does not report a contrast estimate or its uncertainty.
What does randomization contribute?
Random assignment is intended to create a fair basis for comparing assigned treatment strategies. In general, it helps limit systematic differences in baseline factors, though randomization does not ensure identical groups in every realized trial. This study is described as randomized, parallel-group, and unmasked. The registry does not report the randomization procedure, allocation ratio, concealment details, or whether analyses adjusted for any baseline factors. No specific claim about those procedures can be made from the record.
The trial's posted primary endpoint population is only eligible patients. This definition matters because randomized trials can have analysis populations defined in different ways, and the population used affects what the estimate describes. The registry does not provide further detail on eligibility exclusions after assignment or identify a broader intention-to-treat result. It also does not report a direct comparative analysis for EFS.
Why can over-dispersion matter for count outcomes?
As a general statistical concept, over-dispersion occurs when count data vary more than a model assumes. A model that fails to account for that extra variability may understate uncertainty and make results appear more precise than warranted. This is a general consideration for count outcomes; the posted primary endpoint is time-to-event EFS, and the registry record does not report a count model or an over-dispersion analysis for the primary result.
The record includes planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. Such illustrations describe sample sizes under stated planning assumptions; they are not observed power and are not evidence that the original trial had a particular design justification. For time-to-event outcomes, the planning convention describes total events, while other outcomes use participants per arm. The registry does not report the trial's own sample-size justification, and the planning assumptions should not be mistaken for the original protocol's design calculations.
What analysis details are not reported?
The registry record does not report a primary comparison p-value, a confidence interval for the treatment contrast, an adjusted model, interim analyses, or a detailed statistical analysis plan. It also does not state how missing outcome information was handled beyond the definition that patients without an event are censored at last contact. As a result, the arm-level estimates can be described, but the full analysis process and comparative inference cannot be independently assessed from this record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 10 outcome measures, but reports no secondary posted results according to the record. It does not state how many statistical hypotheses were planned, whether secondary outcomes were tested, or whether any procedure was used to control multiplicity. Multiplicity refers, in general, to the increased chance of at least one false-positive finding when many hypotheses are tested. Without the analysis plan and testing details, it is not possible to assess how that issue was handled in this trial.
The registry identifies EFS as the primary outcome and provides an estimate and confidence interval for each arm. It does not post a direct comparison, p-value, or confidence interval for the treatment contrast. Thus the record does not give a formal primary test that could be considered alongside any secondary tests. The number of outcome measures alone does not show that all were analyzed or tested.
For the primary outcome, patients without an event are censored at last contact, and the population is limited to eligible patients. These are the missing-data and analysis-population details explicitly stated for the endpoint. Further information on loss to follow-up, reasons for missing observations, eligibility exclusions, or sensitivity analyses is not reported in the registry record. The record does not identify a full intention-to-treat analysis or explain how missingness beyond last-contact censoring was addressed.
As a general statistical consideration, censoring and missing outcome information can affect time-to-event estimates when follow-up differs or when the people with incomplete follow-up differ systematically from those still observed. The posted record does not provide enough detail to evaluate that possibility. The results should therefore be understood as the registry's eligible-patient estimates under the stated censoring definition, rather than as a complete account of every possible analysis population or missing-data assumption.
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 |
|---|---|---|---|
| Arm A (Combination Chemotherapy) | 8 | 308 | 2.6% |
| Arm B (Combination Chemotherapy, Topotecan Hydrochloride) | 11 | 318 | 3.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Arm A (Combination Chemotherapy) | 51 of 308 |
| Arm B (Combination Chemotherapy, Topotecan Hydrochloride) | 42 of 318 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Arm A (Combination Chemotherapy) | 105 of 308 |
| Arm B (Combination Chemotherapy, Topotecan Hydrochloride) | 91 of 318 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm A (Combination Chemotherapy) | Arm B (Combination Chemotherapy, Topotecan Hydrochloride) |
|---|---|---|---|
| Sepsis | Infections and infestations | 4 of 308 | 2 of 318 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 2 of 308 | 1 of 318 |
| Febrile neutropenia | Blood and lymphatic system disorders | 1 of 308 | 1 of 318 |
| Ascites | Gastrointestinal disorders | 0 of 308 | 2 of 318 |
| Typhlitis | Gastrointestinal disorders | 1 of 308 | 1 of 318 |
| Leukemia secondary to oncology chemotherapy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 308 | 1 of 318 |
| Hypotension | Vascular disorders | 2 of 308 | 0 of 318 |
| Anemia | Blood and lymphatic system disorders | 0 of 308 | 1 of 318 |
| Heart failure | Cardiac disorders | 1 of 308 | 0 of 318 |
| Left ventricular systolic dysfunction | Cardiac disorders | 1 of 308 | 0 of 318 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm A (Combination Chemotherapy) | Arm B (Combination Chemotherapy, Topotecan Hydrochloride) |
|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | 28 of 308 | 25 of 318 |
| Neutrophil count decreased | Investigations | 26 of 308 | 26 of 318 |
| Platelet count decreased | Investigations | 23 of 308 | 22 of 318 |
| Anemia | Blood and lymphatic system disorders | 16 of 308 | 16 of 318 |
| White blood cell decreased | Investigations | 17 of 308 | 13 of 318 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 9 of 308 | 13 of 318 |
| Mucositis oral | Gastrointestinal disorders | 14 of 308 | 7 of 318 |
| Infections and infestations - Other, specify | Infections and infestations | 15 of 308 | 6 of 318 |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | 6 of 308 | 7 of 318 |
| Hypokalemia | Metabolism and nutrition disorders | 7 of 308 | 5 of 318 |
Serious events with the highest arm-level rate: sepsis (1.3%), respiratory failure (0.6%), hypotension (0.6%), ascites (0.6%), febrile neutropenia (0.3%).
The safety record lists serious adverse events among 308 participants at risk in Arm A, with 8 affected, and among 318 participants at risk in Arm B, with 11 affected. Other adverse events are listed among the same arm-specific risk counts, with 105 affected in Arm A and 91 in Arm B. The record also lists deaths: 51 for Arm A and 42 for Arm B.
These figures are counts, not rates or comparative effect estimates. The registry does not provide a statistical comparison, confidence intervals, or an explanation of whether the adverse-event categories overlap. The listed deaths should not be assumed to be identical to deaths counted as EFS events: the safety summary and primary endpoint have distinct reporting contexts, and the registry does not specify their relationship.
The record lists serious adverse-event terms and percentages including sepsis (1.3%), respiratory failure (0.6%), hypotension (0.6%), ascites (0.6%), febrile neutropenia (0.3%), and heart failure (0.3%). It does not identify an arm for each term in this listing, so the percentages should not be assigned to a particular arm. These safety summaries describe reported events; they do not by themselves establish cause or comparative risk.
12. What the Result Does, and Does Not, Mean
The posted primary results show estimated five-year EFS of 77.64% for Arm A and 78.79% for Arm B. Each estimate has a 95% confidence interval, indicating uncertainty around the arm-specific result. The endpoint includes progression, relapse, a second malignant neoplasm, and death from any cause, with patients without an event censored at last contact. The estimates therefore describe a composite time-to-event outcome for eligible patients.
The result does not, by itself, show whether adding the vincristine, topotecan, and cyclophosphamide combination changed EFS. The registry does not report a direct difference between arms or a formal statistical test of the primary comparison. Separate estimates and confidence intervals should not be treated as a substitute for that analysis. The record also does not report an adjusted comparison or details needed to reconstruct one.
These data do not isolate any one component of the combination or any individual event type. The intervention is a treatment strategy that adds a combination to the standard approach; the trial result cannot be interpreted as an estimate for topotecan alone. Nor does the composite EFS estimate show separate effects on progression, relapse, second malignant neoplasms, and death.
The safety counts are also not comparative estimates of risk. Without further information on event definitions, overlap, follow-up, and analysis, the counts should be read as the registry's safety summary rather than as proof that one regimen causes more or fewer events. The posted figures do not establish a treatment benefit or lack of benefit. They state what was estimated and counted in the registry, while leaving the main between-arm inference unreported.
13. Why This Trial Matters Statistically
This trial presents a useful statistical distinction between reporting outcomes by randomized arm and reporting a comparative treatment effect. The registry supplies a five-year EFS estimate and confidence interval for each arm, but does not report the contrast between those arms. Arm-level estimates describe outcomes within groups; the comparative question requires an estimate of how the groups differ, together with uncertainty for that contrast.
The endpoint also illustrates how time-to-event methods handle follow-up. Kaplan-Meier estimation incorporates event timing and censors patients at last contact if they have not had a recorded event. This makes the endpoint suitable for a setting where follow-up may not be identical for everyone, while making the interpretation dependent on the censoring definition and assumptions. The registry states the endpoint and censoring approach, but does not provide the detailed follow-up information needed to assess those assumptions.
The record further distinguishes total enrollment from the eligible-patient population used for the primary endpoint. Clear reporting of analysis populations matters because readers need to know which participants the estimates represent. In this case, the listed arm counts are reported alongside the endpoint, while the relationship to overall enrollment is not explained.
Finally, the safety summaries and EFS outcome answer different questions. Event counts, affected counts, and a time-to-event estimate have different denominators and interpretations. Keeping those summaries separate helps avoid treating raw counts as comparative risks or assuming that safety deaths map directly onto the primary endpoint. The record illustrates why complete analysis details and a direct contrast are important for interpreting a randomized comparison.
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 central limitation of the posted results is that the registry gives arm-specific EFS estimates but does not report the primary between-arm comparison. A contrast estimate, its confidence interval, and a p-value are not reported in the registry record. This prevents a direct assessment of the estimated difference and its precision from the posted primary result alone.
The primary analysis includes only eligible patients, while the registry lists total enrollment of 642 and outcome group counts of 309 for Arm A and 320 for Arm B. The record does not explain how these counts relate or provide details on exclusions, analysis populations, or participant flow. It also does not report event counts or numbers at risk over time, limiting assessment of the information supporting the five-year estimates.
The trial is described as randomized and unmasked, but details on allocation procedures, concealment, adherence, crossovers, and outcome assessment are not reported in the registry record. The posted arm descriptions are incomplete, so the full treatment schedules cannot be assessed from this record. The registry also does not report baseline characteristics or adjusted analyses.
Although 10 outcome measures are listed, no secondary results are posted. A statistical analysis plan, multiplicity approach, interim analyses, trial-specific sample-size justification, and detailed handling of missing outcome data are not reported. The safety summaries lack a comparative analysis, and the relationship between death counts and the EFS endpoint is not explained. These gaps constrain interpretation of the posted efficacy and safety information without establishing that the trial itself lacked these procedures or analyses.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma — NCT01231906.
- Registry record last updated 2026-01-23; status last verified 2026-01.
- Results first posted 2021-05-04.
- 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
NCT01231906 is a completed, randomized, parallel-group, unmasked phase III trial sponsored by the Children's Oncology Group. It enrolled 642 participants with non-metastatic extracranial Ewing sarcoma. Arm A received standard five-drug chemotherapy; Arm B received the standard approach with an additional vincristine, topotecan, and cyclophosphamide combination. The study started on 2010-11-24 and had a primary completion date of 2020-03-31.
The primary outcome was estimated 5-year event-free survival among eligible patients, using Kaplan-Meier estimation. The registry reports 77.64% for Arm A and 78.79% for Arm B, each with a 95% confidence interval. It does not report a direct comparison between arms. Safety counts are also posted, but no comparative safety analysis is reported. Secondary outcome results and further analysis details are not reported in the registry record.