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 Low-dose Intra-arterial Bevacizumab for Edema and Radiation Necrosis Therapeutic Intervention (LIBERTI) (NCT02819479), a na phase 2 study. The primary outcome is Change in Radiation Necrosis and Cerebral Edema After a Single Treatment of Low Dose Intra-arterial Avastin (Bevacizumab).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02819479 |
| Phase | Phase 2 |
| Condition | Radiation Necrosis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 10 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Norton Healthcare |
| Results posted | Yes |
2. Clinical Question
Population
The study population was described as 10 adults with medically refractory brain radiation necrosis and disabling headache. All had received steroids before study enrollment. The registry record does not provide further participant characteristics or report how many participants contributed data to each outcome assessment.
Intervention
The intervention was a single targeted intra-arterial dose of bevacizumab at 2.5 mg/kg, after osmotic blood-brain-barrier disruption using intra-arterial 25% mannitol. The record describes mannitol administration at a rate of 4-12 ml/sec for 30 seconds.
Comparator
This was a single-group study, with no comparator group reported. The registry record lists allocation as not applicable and masking as none. Consequently, the study does not provide a like-for-like control comparison of bevacizumab against another treatment or against no treatment.
Primary question
The primary question was whether radiation necrosis and cerebral edema imaging measures changed after a single treatment. MRI-based volumetric measures were planned at baseline, 3 months and 12 months. The registry record does not report the measured values or the estimated changes, so it does not establish the direction, size or precision of any change.
Additional planned outcomes addressed headache-related morbidity, headache impact, functional status, steroid use and postoperative neurocognitive change. These outcomes provide context for the range of clinical and imaging domains considered, but their measured results are not reported in the registry record. The study's stated purpose included assessing safety and efficacy. Its single-group design can describe outcomes among treated participants, but without a concurrent comparator it cannot separate treatment-associated changes from other explanations, such as the course of the condition or changes over time. The registry record therefore frames the clinical question, but the reported information does not answer whether the intervention caused a change.
3. Trial Design
LIBERTI (NCT02819479) is recorded as a phase 2, completed study sponsored by Norton Healthcare. The registry lists an enrollment of 10 and classifies the design as single group, with allocation marked not applicable and masking marked none. The record gives a start date of 2016-11-23 and a primary completion date of 2019-06-06. These design details describe the study structure and timeline; they do not by themselves indicate what the outcome findings were.
Participants received a single intra-arterial dose of bevacizumab, with osmotic blood-brain-barrier disruption using intra-arterial 25% mannitol. The intervention description specifies 2.5 mg/kg bevacizumab and mannitol delivered at 4-12 ml/sec for 30 seconds. No separate control arm is described. With a single group, the key comparisons are planned changes within participants from baseline to follow-up, rather than differences between randomized groups.
The primary outcome was planned around MRI volumetric assessment of radiation necrosis and cerebral edema at baseline and at 3 months and 12 months after treatment. Other registered outcomes concerned headache-associated morbidity, headache impact, functional status, steroid use and neurocognitive change. The record lists 8 outcome measures and 24 analyses, but does not specify in the information available how those analyses were structured, which populations were included, or how multiple outcomes and time points were handled.
The record does not report a statistical analysis plan, sample-size justification, interim analyses, or detailed rules for handling missing outcome data. It also does not report primary outcome estimates or results for the secondary outcomes. Accordingly, the design can be described, but the registry record does not support a detailed account of the analysis actually conducted or its findings.
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: This was a single-arm study. There was no wash out or run-in period after enrollment. There was no assignment to groups.
Overall Study
| Stage | Low-dose Intra-arterial Bevacizumab |
|---|---|
| STARTED | 10 |
| COMPLETED | 8 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | Low-dose Intra-arterial Bevacizumab |
|---|---|
| Adverse Event | 2 |
Analysis population for the primary outcome, as defined in the registry: 10 adult subjects presented with medically refractory radiation necrosis of the brain and disabling headache. All were treated with steroids prior to study enrollment.
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 | Low-dose Intra-arterial Avastin (Bevacizumab) |
|---|---|---|
| Participants analysed | 10 | |
| Age, Continuous | years | 35.1 (SD 14.8) |
| Sex: Female, Male: Female | Participants | 8 |
| Sex: Female, Male: Male | Participants | 2 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 9 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 9 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 10 |
| MRI of Brain: volume of radiation necrosis | cubic centimeters, or cm^3 | 14.5 (SD 12.1) |
| MRI of Brain: volume of edema | cubic centimeters, or cm^3 | 86.8 (SD 95.9) |
| Headache severity via Migraine Disability Assessment (MIDAS) TOTAL SCORE | units on a scale from 0 to 450 | 81.7 (SD 110.1) |
| DAYS of Headache via Migraine Disability Assessment (MIDAS) | Days of headache over past 3 months | 33.3 (SD 29.8) |
| Headache PAIN LEVEL via Migraine Disability Assessment (MIDAS) | units on a scale from 0 to 10 | 6.9 (SD 2.2) |
| Headache severity via Headache Impact Test (HIT-6) | units on a scale from 36 - 78 | 62.4 (SD 7.5) |
| Cumulative Days of Steroid use during 12 months Pre-Bevacizumab | Days | 52.5 (0 to 100) |
| Karnofsky Performance Status Scale | % on Karnofsky scale | 79.0 (SD 9.9) |
| Digits Forward via Neuropsychological Assessment Battery | T score with Mean=50, SD=10 | 41.1 (SD 11.8) |
6. Primary Endpoint
The registry lists the primary outcome as Change in Radiation Necrosis and Cerebral Edema After a Single Treatment of Low Dose Intra-arterial Avastin (Bevacizumab), measured over Baseline (before treatment), and 3 months and 12 months after single dose intra-arterial Avastin (bevacizumab).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | cm^3 |
| Endpoint classification | Continuous Endpoint |
The primary endpoint concerns change in radiation necrosis and cerebral edema after a single dose of intra-arterial bevacizumab. It is a continuous imaging outcome expressed in cubic centimeters, with the registry specifying a mean and standard deviation. MRI assessment was planned at baseline, before treatment, and at 3 months and 12 months afterward.
The registered method describes quantitative volumetric analysis. Regions of T2 and FLAIR signal prolongation above contralateral white matter were to be quantified in cubic centimeters using a semi-automated thresholding and region-growing technique. Lesion enhancement was also to be measured volumetrically, using a contrast threshold of 40% above background. These measures are intended to turn imaging features into quantities that can be compared over time, rather than relying only on a descriptive reading of the scans.
General statistical context: a continuous measure can capture the magnitude of change across a range of values, while a mean describes the average in the analyzed group and a standard deviation describes variation among observations. Repeated measurements can indicate whether the group’s imaging values differ at follow-up from baseline, but interpretation depends on the observed values, their uncertainty, and the analysis used. Those results and the analysis details are not reported in the registry record. The endpoint's rationale is therefore understandable from its imaging description, but its observed change and precision cannot be assessed from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a completed single-group study, but it does not report the primary imaging outcome estimates. No mean values, standard deviations, changes from baseline, confidence intervals or statistical tests for the primary endpoint are included in the record details. As a result, the direction and magnitude of the imaging changes, and the precision with which they were estimated, are not reported in the registry record. The completion status should not be mistaken for evidence that a particular outcome was observed.
There is also no concurrent comparison group. Any change between baseline and follow-up, if reported, would describe what happened over time among participants who received the intervention. A within-group change alone does not establish that treatment caused that change. General statistical context: a control group can help distinguish an intervention-associated difference from changes that might also occur over time for other reasons. This trial's listed design does not provide that comparison.
The planned assessment points were baseline, 3 months and 12 months. The registry record does not report follow-up completion, the number of observations available at each time point, or whether the same participants contributed measurements across those assessments. Without this information, it is not possible to judge how missing observations may have affected the estimates or whether the reported enrollment corresponds to the analyzed population.
The study also registered several secondary outcome domains, including headache measures, functional status, steroid use and neurocognitive change. Their results are not reported in the registry record. The record lists 8 outcome measures and 24 analyses, but does not explain the relationship among those analyses or report a statistical plan for interpreting them together. General statistical context: when many outcomes or time points are considered, the chance of at least one apparently notable result can increase if each is assessed separately. Whether and how this issue was addressed is not reported in the registry record.
Safety information is reported separately: the registry lists serious adverse events affecting 6 participants and other adverse events affecting 9 participants in the intervention group, with 0 deaths. These figures describe recorded safety events and should not be interpreted as evidence about comparative risk, because no control group is reported. The serious-event terms and percentages are descriptive registry entries, not comparative estimates.
Overall, the available record supports a description of the intended treatment, population, imaging endpoint and reported adverse-event counts. It does not provide enough outcome data to quantify efficacy, assess uncertainty around the primary outcome, or determine whether observed changes were attributable to the intervention. Any stronger conclusion would require results and analysis details that are not reported in the registry record.
9. Statistical Methods Explained
The design is described as single group, with allocation marked not applicable and masking marked none. This means the registry record does not describe random assignment to competing treatment groups or a blinded comparison. The planned outcome structure instead follows participants from baseline to later assessments. General statistical context: repeated measurements can describe how outcomes vary over time within a group, but they do not on their own estimate the difference that would have occurred under an alternative treatment or no treatment.
What does a mean and standard deviation describe?
The primary endpoint is characterized as a mean of a continuous measure, with standard deviation as its dispersion measure. General statistical context: the mean is the arithmetic average of the observations included in an analysis. The standard deviation describes how spread out those observations are around the mean. It is not the same as the uncertainty in the estimated mean; a confidence interval is commonly used to express that estimation uncertainty. The registry record does not report the primary mean, standard deviation or a confidence interval, so none can be interpreted for this outcome.
The endpoint is based on MRI volumetric measurements in cubic centimeters. The record describes quantifying regions of T2 and FLAIR prolongation above contralateral white matter through semi-automated thresholding and region-growing. It also describes volumetric assessment of lesion enhancement using a contrast threshold of 40% above background. General statistical context: a quantitative measurement process can support comparison across planned time points, but interpretation also depends on consistent measurement procedures and the analysis population. Further details about measurement reliability, reader procedures or quality control are not reported in the registry record.
How should change over time be understood?
Baseline, 3-month and 12-month assessments were planned. A change score describes the difference between measurements at different times for the participants included in that analysis. General statistical context: a group-level mean change summarizes average movement, while individual participants may have changes in different directions or of different sizes. The precision of an estimated change depends on the observed data and their variability. The registry record does not report change estimates, their uncertainty, or whether the analysis compared follow-up values directly with baseline values or used another approach.
Repeated measurements from the same participant are related rather than independent. General statistical context: analyses of longitudinal data often account for this within-participant relationship. The record does not specify whether a repeated-measures model, paired comparison, or another method was used. It also does not report assumptions about the distribution of measurements, transformations, covariate adjustment, or how values outside expected ranges were handled. No particular analytical method should therefore be attributed to the study based on the registry information available.
What does the single-group design allow?
A single-group study can describe observed outcomes among people who received the intervention. If complete outcome estimates were available, they could show the amount of change observed over time in that group. General statistical context: without a comparator, the difference between baseline and follow-up cannot isolate the contribution of treatment from other possible influences. The registry record lists no randomized comparison and no control arm. It also does not report an external comparison group or an analysis designed to emulate one.
Masking is listed as none. General statistical context: knowledge of treatment or assessment status can potentially influence subjective measurements, decisions about follow-up, or how outcomes are recorded. The extent of any such influence depends on the outcome and procedures. For this imaging endpoint, the registry record does not give enough information about image readers or assessment blinding to judge that issue. The registered secondary outcomes include headache and functional measures, but their measurement procedures and results are not reported in detail.
What can be said about precision and planning?
A confidence interval, when reported, describes a range of values compatible with the data under the model used and communicates uncertainty around an estimate. A p-value, when reported, describes how surprising data at least as extreme as those observed would be under a specified null model and assumptions. Neither establishes clinical importance by itself. The registry record does not report confidence intervals or p-values for the primary imaging endpoint, so the statistical precision and evidence against a no-change hypothesis cannot be assessed from this record.
General statistical context: sample-size calculations are planning exercises based on assumptions about the target effect, variability, significance threshold and desired power. The registry record's sample-size assumptions describe illustrations based on an observed effect, with two-sided significance level 0.05, equal allocation between two arms and a normal approximation. Those illustrations are not observed power and are not the study's own design justification. The design recorded for LIBERTI is single group, and the underlying primary outcome effect and planning results are not reported in the registry record. No sample-size justification for the actual study is reported.
The record does not report an interim analysis plan or the statistical analysis plan. It also does not describe handling of missing values, analysis populations, multiplicity adjustments, or model diagnostics. These omissions matter because they determine how measurements are included, how uncertainty is estimated, and how multiple results are interpreted. The outcome descriptions and design can be read as the registered intentions, but they should not be treated as a complete account of the statistical methods actually used.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 8 outcome measures and 24 analyses. The primary outcome is an imaging measure planned at baseline, 3 months and 12 months. Secondary measures cover headache-associated morbidity, headache impact, functional status, steroid usage and postoperative neurocognitive change. Considering multiple outcomes and assessment times raises a multiplicity question: separate tests can produce apparently notable findings even when there is no underlying effect. General statistical context: investigators may address multiplicity through a prespecified hierarchy, adjustment procedures, or by treating analyses as exploratory. Which approach, if any, was used is not reported in the registry record.
Missing data are also relevant to longitudinal assessment. The registry does not report the number of participants with measurements at each planned time point, reasons for missing assessments, or the method used to handle missing values. General statistical context: if participants with missing follow-up differ systematically from those with observed follow-up, analyses limited to observed cases may not represent the original enrolled group. Methods such as imputation or likelihood-based longitudinal models make assumptions about missingness, and those assumptions need to be considered. No missing-data approach is reported in the registry record.
The analysis populations are not described. It is therefore not reported in the registry record whether outcomes were analyzed for all enrolled participants, only those completing treatment, or another defined group. No details are reported about exclusions, protocol deviations, or whether safety and efficacy analyses used different populations. These gaps limit assessment of the representativeness of any potential estimates. The registry record also does not report a prespecified multiplicity strategy, analysis populations, or missing-data rules, so these issues cannot be resolved from the available information.
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 |
|---|---|---|---|
| Low-dose Intra-arterial Bevacizumab | 6 | 10 | 60.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Low-dose Intra-arterial Bevacizumab | 0 of 10 |
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 |
|---|---|
| Low-dose Intra-arterial Bevacizumab | 9 of 10 |
Most frequent serious adverse event terms
| Event term | Organ system | Low-dose Intra-arterial Bevacizumab |
|---|---|---|
| Seizure | Nervous system disorders | 2 of 10 |
| Acute encephalopathy | Nervous system disorders | 1 of 10 |
| Double Vision | Nervous system disorders | 1 of 10 |
| Chest Pain | Cardiac disorders | 1 of 10 |
| Headache | Nervous system disorders | 1 of 10 |
| Dizziness | Nervous system disorders | 1 of 10 |
| Dysarthria | Nervous system disorders | 1 of 10 |
| Left Lower Extremity Hemiparesis | Nervous system disorders | 1 of 10 |
| Left Upper Extremity Hemiparesis | Nervous system disorders | 1 of 10 |
| Cerebral Edema | Nervous system disorders | 1 of 10 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Low-dose Intra-arterial Bevacizumab |
|---|---|---|
| Headache | Nervous system disorders | 5 of 10 |
| Blurred vision | Eye disorders | 4 of 10 |
| Fall | General disorders | 2 of 10 |
| Neck pain | Musculoskeletal and connective tissue disorders | 2 of 10 |
| Numbness | Nervous system disorders | 2 of 10 |
| Leg cramps | Musculoskeletal and connective tissue disorders | 2 of 10 |
| Seizures | Nervous system disorders | 2 of 10 |
| Traumatic Fall | Injury, poisoning and procedural complications | 2 of 10 |
| Vomiting | Gastrointestinal disorders | 2 of 10 |
| 1st degree AV block | Cardiac disorders | 1 of 10 |
Serious events with the highest arm-level rate: seizure (20.0%), acute encephalopathy (10.0%), double vision (10.0%), chest pain (10.0%), headache (10.0%).
The registry reports safety information for the low-dose intra-arterial bevacizumab group. Serious adverse events were recorded as affecting 6 participants among 10 at risk; other adverse events were recorded as affecting 9 participants among 10 at risk. Deaths are listed as 0. The record does not provide a comparator group, so these counts are descriptive and do not estimate a difference in risk between treatment strategies.
The serious adverse-event terms listed include Seizure at 20.0%, Acute encephalopathy at 10.0%, Double Vision at 10.0%, Chest Pain at 10.0%, Headache at 10.0% and Dizziness at 10.0%. These entries identify terms and percentages in the registry record; they do not establish that the intervention caused each event. The record does not provide further detail about timing, duration, severity criteria, relatedness assessments, recurrence, or how the listed terms overlap within participants. The percentages should therefore be read as descriptive event reporting, not as comparative evidence or a complete characterization of the safety profile.
General statistical context: safety event counts in a small single-group study can describe what was recorded in the participants under observation, but they cannot by themselves establish how often those events would occur under another treatment or in a broader population. The registry record does not report comparative safety analyses or detailed event-level information.
12. What the Result Does, and Does Not, Mean
The record describes a phase 2, completed, single-group study of a single intra-arterial bevacizumab treatment following osmotic blood-brain-barrier disruption with intra-arterial 25% mannitol. Its primary outcome was planned as an MRI-based volumetric assessment of radiation necrosis and cerebral edema at baseline, 3 months and 12 months. The registry record does not report the observed primary outcome values or changes. It therefore does not establish how the imaging measures changed or how precisely any change was estimated.
The absence of a comparator also limits causal interpretation. Even if a change from baseline were reported, a within-group pattern would not show what would have happened to similar participants under a different strategy. General statistical context: the purpose of a control comparison is to estimate a contrast between treatment conditions, helping separate treatment-associated differences from changes over time or other influences. No like-for-like comparison is described in this record.
The registered secondary outcomes indicate that headache burden, functional status, steroid use and neurocognitive change were also of interest. However, their observed results are not reported in the registry record. The available safety information lists serious and other adverse-event counts, named serious-event terms and deaths. These are descriptive records for the intervention group, not estimates of comparative safety.
What the record does support is a concise account of the planned population, treatment procedure, outcome timing and reported safety counts. What it does not support is a conclusion about treatment efficacy, causal benefit or harm, or the clinical importance of any imaging or symptom change. The missing outcome estimates, uncertainty measures, analysis methods and follow-up details prevent a quantitative assessment of the primary question. Interpretation should remain limited to the design and information actually reported.
13. Why This Trial Matters Statistically
This study is statistically notable as a single-group investigation of an imaging-based outcome measured over time. Its primary endpoint uses MRI volumetric measures, rather than a binary event, and the registry specifies a mean and standard deviation. This structure makes the planned question one of quantitative change from baseline across follow-up assessments. Such a design can be useful for documenting a treatment experience and generating evidence to inform later research questions.
At the same time, it makes the distinction between observed change and treatment effect especially important. Without a control group, a before-and-after contrast cannot isolate the intervention's contribution. General statistical context: changes over time may reflect treatment, the natural course of a condition, measurement variation, co-interventions or other factors. A controlled comparison can help address some of these alternatives, while a single-group design cannot make the same direct comparison.
The registry also lists multiple secondary outcome domains and analyses. That breadth can be useful for describing different aspects of participants' experience, but it brings questions about multiplicity, missing observations and analysis populations. Those statistical details are not reported in the registry record. The absence of primary outcome estimates is particularly consequential: without the mean change and its uncertainty, readers cannot judge magnitude or precision.
Accordingly, the record matters as a clear example of why design features and outcome reporting must be considered together. Completion status, a defined imaging approach and safety counts do not substitute for reported outcome estimates or a comparator. The information available supports understanding what the trial set out to assess, while leaving the central efficacy interpretation unresolved.
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 principal limitation for interpretation is the single-group design. The registry reports no control arm and lists allocation as not applicable, so treatment outcomes cannot be compared directly with outcomes under another strategy. Any before-and-after change, if available, would not alone establish that the intervention caused it. Masking is listed as none, and further information about assessment procedures or image-reader blinding is not reported in the registry record.
The registry record does not report the primary endpoint results, including mean imaging values, changes, standard deviations, confidence intervals or statistical tests. It also does not report results for the secondary outcomes. This prevents assessment of the direction, size or precision of outcome changes. Although the primary endpoint was planned at baseline and at 3 months and 12 months, the record does not state how many participants completed each assessment or whether follow-up measurements were available for the same participants.
Further limitations arise from the absence of reported analysis details. The statistical analysis plan, sample-size justification, missing-data methods, analysis populations and multiplicity strategy are not reported in the registry record. Measurement reliability and procedures for quality control are also not described in the information available. These omissions make it difficult to assess the robustness of any potential estimates, even apart from the lack of a comparator.
The safety record provides event counts and selected serious-event terms, but not detailed event-level timing, duration, relatedness or comparative estimates. The trial's recorded enrollment was 10, and the safety group lists 10 at risk; the available record does not provide enough additional information to judge the representativeness of the observed events beyond that study group. These limitations constrain conclusions to the registered design and descriptive information reported.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Low-dose Intra-arterial Bevacizumab for Edema and Radiation Necrosis Therapeutic Intervention (LIBERTI) — NCT02819479.
- Registry record last updated 2022-05-24; status last verified 2022-05.
- Results first posted 2021-06-28.
- 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
LIBERTI (NCT02819479) is a completed phase 2, single-group study sponsored by Norton Healthcare. The registry records enrollment of 10, allocation as not applicable and masking as none. Participants were described as adults with medically refractory brain radiation necrosis and disabling headache who had received steroids before enrollment.
The intervention was a single 2.5 mg/kg intra-arterial bevacizumab dose after osmotic blood-brain-barrier disruption with intra-arterial 25% mannitol. The primary outcome was planned as MRI-based volumetric change in radiation necrosis and cerebral edema at baseline, 3 months and 12 months.
Primary and secondary outcome results are not reported in the registry record. Safety entries list serious adverse events affecting 6 participants, other adverse events affecting 9 participants and 0 deaths. The single-group design does not provide a control comparison, and the registry does not report the statistical analysis plan or key details about missing data and analysis populations.