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 Bevacizumab in Treating Patients With Recurrent or Progressive Meningiomas (NCT01125046), a na phase 2 study. The primary outcome is Progression Free Survival (PFS) of Patients With Recurrent or Progressive Meningiomas Treated With Bevacizumab at 6 Months.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01125046 |
| Phase | Phase 2 |
| Condition | Acoustic Schwannoma, Adult Anaplastic Meningioma, Adult Ependymoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 50 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Northwestern University |
| Results posted | Yes |
2. Clinical Question
Population
Patients with recurrent or progressive meningiomas, including grades I–III, despite prior therapy. The registry notes that outcomes were analyzed by tumor grade because prognosis differs by grade.
Intervention
Bevacizumab. The described schedule begins with intravenous treatment every 2 weeks for 6 months; patients may then receive it every 3 weeks for up to 12 months, while treatment continues in the absence of progression or unacceptable toxicity.
Comparator
There is no comparison arm. The registry describes a single-group trial with allocation recorded as NA, so it does not provide a like-for-like control group for estimating a treatment contrast.
Primary question
What percentage of patients with recurrent or progressive meningiomas are progression-free at 6 months after starting bevacizumab? The primary endpoint is defined using progression or death, with progression assessed according to the Macdonald Criteria.
This question is about the observed course of patients in the trial, not a randomized comparison of bevacizumab with another treatment. The study enrolled 50 participants and is listed as completed. Its primary outcome is specified as a percentage with a 95% confidence interval, but the estimate and interval are not reported in the registry record. The tables and plots should therefore be read as displays of posted information, not as evidence that an unreported primary result can be reconstructed from the trial description.
3. Trial Design
This is a phase II, single-group trial sponsored by Northwestern University. The registry lists an enrollment of 50 and a completed status. The recorded study start is 2010-06-17, and the primary completion date is 2014-03-10. Allocation is recorded as NA, and masking is recorded as none. There is no randomized comparator arm described in the record.
The intervention is bevacizumab. The arm description specifies intravenous treatment every 2 weeks for 6 months, with the option of treatment every 3 weeks for up to 12 months afterward. Treatment is described as continuing in the absence of disease progression or unacceptable toxicity. This is the recorded schedule; further operational details, including how treatment changes were handled in analysis, are not reported in the registry record.
The primary outcome concerns progression-free survival at 6 months in patients with recurrent or progressive meningiomas. The registry says the analysis was considered by tumor grade because prognosis differs by grade. It defines progression using the Macdonald Criteria and includes death from any cause in the progression-free survival definition. The endpoint is expressed as a percentage of patients and is specified with a 95% confidence interval.
Other listed outcome topics include response, safety, tumor-tissue expression measures, and overall survival at specified follow-up points. The registry lists five outcome measures and zero analyses. That listing does not supply a numerical primary endpoint result or enough detail to reconstruct the statistical analysis. A protocol, sample-size justification, interim-analysis plan, and detailed statistical analysis plan are not reported in the registry record.
Because the trial has no control arm, its design can describe outcomes among enrolled participants but cannot, by itself, separate a treatment effect from other explanations for those outcomes. The absence of masking is also relevant when interpreting outcomes that require judgment, although the registry’s endpoint definition supplies criteria for assessing progression.
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.
First 6 Months of Treatment
| Stage | Treatment With Bevacizumab |
|---|---|
| STARTED | 50 |
| COMPLETED | 36 |
| NOT COMPLETED | 14 |
Reasons for not completing this period:
| Reason | Treatment With Bevacizumab |
|---|---|
| Death | 1 |
| Withdrawal by Subject | 2 |
| Non-compliance | 1 |
| Surgery | 1 |
| Progressive Disease | 7 |
| Adverse Event | 2 |
Continued Treatment After 6 Months
| Stage | Treatment With Bevacizumab |
|---|---|
| STARTED | 36 |
| COMPLETED | 33 |
| NOT COMPLETED | 3 |
Reasons for not completing this period:
| Reason | Treatment With Bevacizumab |
|---|---|
| Progressive Disease | 2 |
| Adverse Event | 1 |
Follow-up/Data Cut Off Point
| Stage | Treatment With Bevacizumab |
|---|---|
| STARTED | 49 |
| COMPLETED | 16 |
| NOT COMPLETED | 33 |
Reasons for not completing this period:
| Reason | Treatment With Bevacizumab |
|---|---|
| Death | 29 |
| Lost to Follow-up | 4 |
Analysis population for the primary outcome, as defined in the registry: PFS was analyzed based on grading of meningioma due to the difference in prognosis of grades to provide meaningful results. In general, grade I tumor grows slowly, grade II tumor grows more quickly and is often called atypical meningioma, and grade III tumor grows and spreads very quickly and is often called anaplastic or malignant meningioma.
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 | Treatment With Bevacizumab |
|---|---|---|
| Participants analysed | 50 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 37 |
| Age, Categorical: >=65 years | Participants | 13 |
| Sex: Female, Male: Female | Participants | 26 |
| Sex: Female, Male: Male | Participants | 24 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 5 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 45 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 |
| Race (NIH/OMB): White | Participants | 47 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | Participants | 50 |
| Stage of Disease (at study entry): Stage I | Participants | 15 |
| Stage of Disease (at study entry): Stage II | Participants | 22 |
| Stage of Disease (at study entry): Stage III | Participants | 13 |
| Diagnosis: Meningioma | Participants | 42 |
| Diagnosis: Hemangiopericytoma | Participants | 4 |
| Diagnosis: Acoustic Neuroma/Vestibular Schwannoma | Participants | 4 |
6. Primary Endpoint
The registry lists the primary outcome as Progression Free Survival (PFS) of Patients With Recurrent or Progressive Meningiomas Treated With Bevacizumab at 6 Months, measured over From the start of treatment and up until 6 months of treatment or follow up.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of patients |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of patients who remain progression-free at 6 months after treatment starts. The registry defines progression-free survival from study registration until the first documentation of progressive disease or death from any cause. Progression is assessed using the Macdonald Criteria. The definition includes a 25% increase in the sum of products of measurable lesions compared with the smallest sum observed, or baseline if there was no decrease. It also includes clear worsening of evaluable disease, a new lesion or site, or clear worsening or failure to return for evaluation because of death or a deteriorating condition, unless clearly unrelated to the cancer.
Progression-free survival is used to summarize how long participants avoid a defined progression event or death. Reporting the endpoint at a specified follow-up point makes the result interpretable as a proportion at that time, rather than as a description of tumor measurements alone. The registry notes that tumor grade was considered because grades have different prognoses; grade-specific interpretation is therefore important if results are displayed by grade.
The endpoint description and planned measure are present, but the observed percentage and its 95% confidence interval are not reported in the registry record. Without those values, the result’s magnitude and precision cannot be assessed. The endpoint definition also does not establish that any observed outcome was caused by treatment, especially in a single-group study without a control arm.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry specifies a clinically interpretable primary outcome: the percentage of participants who are progression-free at 6 months. However, it does not report the primary estimate or its 95% confidence interval. As a result, the posted record does not establish what proportion met the endpoint, nor how precisely that proportion was estimated. The trial description alone cannot fill that gap.
A confidence interval communicates uncertainty around an estimate. A narrower interval generally indicates greater precision, while a wider one indicates that a broader range of values remains compatible with the data and analysis. Here, the confidence interval is part of the stated outcome specification, but its bounds are not reported in the registry record. No conclusion about the endpoint’s precision can be drawn without them.
The design is single-group, with no randomized control arm. Any outcome in the treated group is therefore descriptive of these participants and their follow-up. It cannot establish how those same participants would have fared under a different treatment or no treatment. Differences in disease course, prior treatment, tumor grade, follow-up, and other factors can affect outcomes; the registry record does not provide a controlled comparison that would address these possibilities.
Grade is specifically relevant because the registry says prognosis differs across grades and that progression-free survival was analyzed based on grading. If results are shown separately by grade, those estimates should be understood as subgroup descriptions. The registry does not report the subgroup estimates, their uncertainty, or details about how the grade-based analyses were specified. It is therefore not possible to determine how stable or comparable any grade-specific findings are from this record.
The registry lists response, safety, tumor-tissue expression, and overall survival among outcome topics. Those outcomes answer different questions from the primary progression-free survival endpoint. A response measure concerns observed tumor response; safety outcomes describe adverse events; tissue-expression analyses concern relationships between measured markers and response; and overall survival concerns whether participants are alive at follow-up points. The record does not report numerical results for these topics in the registry record, so they should not be treated as evidence for or against the primary endpoint.
The adverse-event record lists 22 participants affected by serious adverse events among 50 at risk, 50 affected in the other adverse-event category among 50 at risk, and 30 deaths. These are registry counts, not an estimate of how many events were caused by bevacizumab. The record does not explain the relationship between the deaths and treatment or provide enough detail to attribute events to the intervention. Serious-event terms are also listed with percentages, but their interpretation depends on the registry’s event definitions and reporting conventions.
Overall, the posted information describes the trial design and endpoint definitions, but does not report the primary efficacy result. The suitable statistical reading is therefore limited: the study planned to characterize six-month progression-free survival in a treated group, while the estimate, its precision, and the evidence needed for a treatment comparison are absent from the registry record.
9. Statistical Methods Explained
A primary endpoint translates the research question into an outcome that can be summarized consistently. In this trial, the endpoint is expressed as a percentage of patients and concerns progression-free survival at 6 months. This combines a defined disease-progression event with death from any cause. The endpoint’s interpretation depends on both the follow-up time and the rules used to classify progression.
What does the confidence interval add?
The registry specifies a 95% confidence interval alongside the percentage. In general, a confidence interval is a range calculated from study data to express uncertainty around an estimated quantity under the chosen statistical method. It is not a guarantee that the true value lies in the particular interval, nor does it describe the range of individual patient outcomes. To read this trial’s interval, a reader would need both its lower and upper bounds and the method used to calculate it. Those bounds and the calculation details are not reported in the registry record.
For a percentage, precision depends in part on how much information is available and on the observed pattern of outcomes. A percentage without an interval can give a point summary but does not show how uncertain that summary is. Since the registry does not post the primary percentage or interval here, neither the size nor precision of the primary result can be assessed.
How should the endpoint definition be read?
The registry uses the Macdonald Criteria to define progression. The definition includes a 25% increase in the sum of products of measurable lesions relative to the smallest sum observed, or baseline when no decrease occurred. It also includes other specified progression conditions, such as a new lesion or clear worsening of evaluable disease. Death is included as an event in the progression-free survival definition. These rules help make the endpoint more reproducible, but application still depends on assessment and on the availability of follow-up information. The record does not report details of adjudication or handling of uncertain assessments.
The endpoint is reported at a fixed follow-up point, while the description defines progression-free survival from registration until progression or death. These are related ways of framing the time-to-event outcome: one asks about status at a specified point, and the other describes time until an event. The registry’s listed measure is a percentage at 6 months; additional time-to-event methods, such as a particular estimator or censoring procedure, are not reported in the registry record. They should not be assumed from the endpoint name alone.
What does a single-group design allow?
A single-group study summarizes outcomes among participants receiving the intervention. It does not directly estimate the difference between bevacizumab and a comparator because no comparator group is described. Even a precisely estimated proportion would describe the study group under its observed conditions; it would not alone identify what would have happened to the same participants under another approach. The registry records allocation as NA and masking as none, and no like-for-like control comparison is available.
Masking can affect outcomes when assessment involves judgment, while a stated progression definition can support consistent classification. Neither feature creates a control group. The record does not report whether progression assessments were independently reviewed or whether assessors were unaware of other information, so those procedures cannot be described.
What can be inferred from the analysis listings?
The registry lists zero analyses. This does not reveal the calculations used for the outcome, because an analysis count is not a detailed statistical plan. The record does not report the approach to missing follow-up, censoring, analysis populations, subgroup uncertainty, or adjustment for multiple outcomes. These omissions limit assessment of whether the methods were prespecified and how they affected the posted results. The protocol and sample-size justification are also not reported in the registry record.
The accompanying sample-size material should be distinguished from the trial’s observed findings. The stated planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of the observed effect. It is explicitly a planning illustration, not the trial’s design or observed power. Because this trial is single-group, those illustrative two-arm assumptions do not describe its allocation. Planning sample sizes are hypothetical design calculations; they are not a measure of how likely the completed study was to detect an effect.
More generally, sample-size calculations depend on assumptions about the target effect, variability or event pattern, significance level, and desired power. They do not establish that an effect exists, and they cannot repair missing outcome data. In this record, the observed primary endpoint and its uncertainty are not reported, so no result-based assessment can be made from the endpoint description alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures, including progression-free survival, response, safety, tumor-tissue expression in relation to response, and overall survival at specified follow-up points. When a study examines several outcomes or subgroup results, the chance of seeing an apparently notable finding can increase if many results are tested or selected for emphasis. Statistical procedures can address this issue, but the registry record does not report a multiplicity strategy. It is also not possible to tell from the outcome list alone which analyses, if any, were formally tested or designated as primary beyond the stated primary endpoint.
Missing follow-up can affect a progression-free survival analysis because a participant’s status may not be known through the relevant time point. Common methods make assumptions about censoring or use other approaches for incomplete observations; those methods and their assumptions are not reported in the registry record. The endpoint description mentions failure to return for evaluation due to death or deteriorating condition as part of the progression definition, unless clearly unrelated to the cancer. It does not specify how other missed visits, incomplete assessments, or loss to follow-up were handled.
The analysis population is not described. The registry lists an enrollment of 50, but it does not state how many participants contributed to the primary endpoint analysis or how exclusions, discontinuations, or unevaluable assessments were handled. The registry’s analysis count is zero, and a detailed analysis plan is not reported in the registry record. As a result, readers cannot verify the analysis denominator, missing-data approach, prespecification, or any adjustment for multiple outcomes from this record.
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 |
|---|---|---|---|
| Treatment With Bevacizumab | 22 | 50 | 44.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment With Bevacizumab | 30 of 50 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 4% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Treatment With Bevacizumab | 50 of 50 |
Most frequent serious adverse event terms
| Event term | Organ system | Treatment With Bevacizumab |
|---|---|---|
| Seizure | Nervous system disorders | 5 of 50 |
| Pancreatitis | Gastrointestinal disorders | 1 of 50 |
| Anorectal Infection | Infections and infestations | 1 of 50 |
| Muscle weakness | Musculoskeletal and connective tissue disorders | 1 of 50 |
| Toxic Metabolic Encephalopathy | Nervous system disorders | 1 of 50 |
| Epistaxis | General disorders | 1 of 50 |
| Aphasia | Nervous system disorders | 1 of 50 |
| Anemia | Blood and lymphatic system disorders | 1 of 50 |
| Fracture | Injury, poisoning and procedural complications | 1 of 50 |
| Left sided apraxia and numbness | Nervous system disorders | 1 of 50 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Treatment With Bevacizumab |
|---|---|---|
| General disorders and administration site conditions - Fatigue | General disorders | 21 of 50 |
| Headaches | Nervous system disorders | 21 of 50 |
| Hypertension | Vascular disorders | 21 of 50 |
| Hyperglycemia | Metabolism and nutrition disorders | 19 of 50 |
| General disorders and administration site conditions - pain | General disorders | 18 of 50 |
| Gastrointestinal disorders - Nausea | Gastrointestinal disorders | 16 of 50 |
| Proteinuria | Renal and urinary disorders | 16 of 50 |
| Hypoalbuminemia | Metabolism and nutrition disorders | 14 of 50 |
| Nose bleed | Respiratory, thoracic and mediastinal disorders | 11 of 50 |
| Gastrointestinal disorders - Diarrhea | Gastrointestinal disorders | 10 of 50 |
Serious events with the highest arm-level rate: seizure (10.0%), pancreatitis (2.0%), anorectal infection (2.0%), muscle weakness (2.0%), toxic metabolic encephalopathy (2.0%).
The registry’s serious adverse-event group lists 50 participants at risk and 22 affected. The other adverse-event category lists 50 at risk and 50 affected. The record also lists 30 deaths. These counts describe what is posted in the registry; they should not be read as proof that bevacizumab caused the events or deaths. The record does not explain the relationship between the deaths and treatment, or provide additional detail about event timing, duration, severity criteria, or individual-level overlap between categories.
The listed serious-event terms include Seizure at 10.0%, and Pancreatitis, Anorectal Infection, Muscle weakness, Toxic Metabolic Encephalopathy, and Epistaxis at 2.0% each. These are presented as percentages in the registry. The denominator and reporting conventions for each term are not specified in the registry record, so the percentages should be read as registry-reported figures rather than recalculated rates. A term listing does not by itself show whether an event occurred once or repeatedly, or establish causation.
Safety counts are distinct from the primary progression-free survival endpoint. They provide information about reported adverse events, but the record does not include enough context to make causal comparisons or to characterize individual risk beyond the posted figures.
12. What the Result Does, and Does Not, Mean
This trial is a phase II evaluation of bevacizumab in a group of patients with recurrent or progressive meningiomas. Its primary question concerns the percentage of participants who are progression-free at 6 months, using a specified progression definition and including death as an event. The registry reports the design and endpoint description, but the primary percentage and its 95% confidence interval are not reported in the registry record.
That absence limits what can be concluded from the posted material. Readers cannot assess the observed six-month progression-free proportion, its precision, or whether the result differs across grades. The registry notes that grade was considered because prognosis differs by grade, but grade-specific numerical findings are not included. Other outcome topics are listed, but their numerical results are not reported in the registry record either.
The single-group design also limits interpretation. Outcomes among participants receiving bevacizumab do not, by themselves, establish what would have occurred under a different treatment or without treatment. Without a control arm, differences in patient characteristics, disease course, previous therapy, and follow-up cannot be separated from an intervention effect by a randomized comparison. The record therefore supports a description of the study’s question and design, not a causal treatment conclusion.
The adverse-event counts and listed terms should likewise be treated as registry reports, not as proof of treatment causation. The record does not explain how the deaths relate to treatment. Nor does it provide enough detail to assess event timing, overlap among categories, or the analysis denominator for the primary outcome.
In short, the record establishes that the study enrolled 50 participants, was completed, and specified a six-month progression-free survival endpoint. It does not report the primary outcome estimate or the information needed to judge its precision. The tables and plots can help organize posted results where available, but they cannot replace results that are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the distinction between a clearly described endpoint and a reported endpoint result. The registry defines progression-free survival, gives a follow-up point, and specifies a confidence interval. Those details clarify what the study intended to measure. Yet without the estimate and interval, readers cannot evaluate the observed result or its uncertainty. A well-defined measure is necessary for interpretation, but it is not a substitute for reporting the data summary.
The study also illustrates the interpretive limits of a single-group design. A treated cohort can provide descriptive information about outcomes and adverse events in the enrolled participants. It cannot provide the same treatment contrast as a randomized comparison. This distinction matters when readers move from a numerical outcome to a claim about cause or comparative benefit.
Grade-based analysis is another important statistical feature. The registry identifies different prognoses across grades and says the primary outcome was analyzed by grade. Such stratification can make summaries more clinically interpretable, but it also creates a need to report subgroup estimates and their uncertainty. Those numerical details and the planned approach are not reported in the registry record.
Finally, the record separates trial-specific methods from planning illustrations. Sample-size illustrations based on observed effects are not the trial’s original design justification and are not observed power. Recognizing that distinction prevents a hypothetical planning calculation from being mistaken for evidence about the completed study. Taken together, the record highlights why endpoint definitions, analysis details, uncertainty estimates, and design limitations all matter when interpreting clinical trial results.
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 most direct limitation for interpreting efficacy is that the primary progression-free survival percentage and its 95% confidence interval are not reported in the registry record. Without them, the magnitude and precision of the primary result cannot be evaluated. The same applies to grade-specific results, despite the registry’s statement that analysis considered tumor grade.
The trial has a single-group design and no comparator arm. The results therefore cannot provide a randomized estimate of the difference between bevacizumab and another treatment. The record also lists no masking. Although the endpoint uses defined progression criteria, details of assessment procedures, independent review, and handling of uncertain cases are not reported in the registry record.
The registry lists an enrollment of 50, but the number included in each outcome analysis and the analysis population are not reported. Methods for incomplete follow-up, censoring, missing assessments, and treatment discontinuation are also not reported. These details matter for interpreting a time-related outcome and understanding which participants contributed information at the endpoint.
The record lists several outcome topics but does not report a multiplicity plan or a detailed statistical analysis plan. It does not provide a sample-size justification for the trial, interim-analysis information, or the procedures used for any grade-based comparisons. The presence of planning illustrations elsewhere should not be taken as a substitute for those trial-specific details.
Safety interpretation is limited as well. The registry posts affected counts, serious-event terms, percentages, and a death count, but the registry entries do not specify event timing, overlap among participants, term-specific denominators, or the relationship between deaths and treatment. These constraints mean the counts can be described but not attributed causally from this record alone.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Bevacizumab in Treating Patients With Recurrent or Progressive Meningiomas — NCT01125046.
- Registry record last updated 2021-01-22; status last verified 2020-10.
- Results first posted 2021-01-22.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a completed phase II, single-group trial of bevacizumab for recurrent or progressive meningiomas. Northwestern University is listed as sponsor, enrollment is 50, and the recorded dates are 2010-06-17 for study start and 2014-03-10 for primary completion. Masking is recorded as none, and allocation as NA.
The primary outcome is the percentage of patients progression-free at 6 months, with a 95% confidence interval specified. Progression is defined using the Macdonald Criteria, and death from any cause is included. The primary estimate and interval are not reported in the registry record. The record lists other outcome topics and adverse-event figures, but does not provide the detailed analysis methods, analysis population, missing-data procedures, or multiplicity approach.