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 Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD (NCT00499590), a randomized phase 3 study. The primary outcome is Visual Acuity.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00499590 |
| Phase | Phase 3 |
| Condition | Macular Degeneration |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 338 |
| Arms in the primary outcome | n/a |
| Lead sponsor | OPKO Health, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
People with exudative age-related macular degeneration, also described as wet AMD. The registry lists Macular Degeneration as the condition. Enrollment was 338.
Intervention
Bevasiranib maintenance after pretreatment with three Lucentis injections. One study group was assigned bevasiranib every 8 weeks, and another was assigned it every 12 weeks. Both schedules included initial bevasiranib priming doses at weeks 2 and 6, with maintenance beginning at week 12.
Comparator
Lucentis, also named ranibizumab, administered every 4 weeks. The registry describes this as monotherapy and specifies a 0.5mg dose for this group.
Primary question
At week 60, did participants avoid a loss of three or more lines of vision under the study’s treatment strategies? The primary outcome is described as visual acuity and as avoidance of three or more lines of vision loss. The registry reports zero participants analyzed for this outcome because the study ended early, so it does not answer the comparison.
The question concerns whether two less-frequent bevasiranib maintenance schedules, used after Lucentis pretreatment, could be compared with continued Lucentis every 4 weeks on the stated visual-acuity outcome. The registry planned three treatment options, assigned participants at random. It also lists secondary outcomes related to rescue therapy and a gain of three or more lines in vision. Those secondary outcomes do not replace the primary question, and the registry does not report analyzed results for them.
3. Trial Design
NCT00499590 is described as a phase 3, randomized, quadruple-masked, parallel-assignment study. The registry lists enrollment of 338 and a planned treatment period of 104 weeks. The study status is terminated. Its start is recorded as 2007-08, and primary completion as 2009-03. The registry names OPKO Health, Inc. as sponsor.
The three arms used different schedules. The Lucentis group received 0.5mg every 4 weeks. In the bevasiranib groups, participants first received three Lucentis injections and bevasiranib priming doses at weeks 2 and 6. Maintenance bevasiranib at 2.5mg began at week 12, with one group assigned treatment every 8 weeks and the other every 12 weeks. The registry describes the trial as comparing these strategies with Lucentis monotherapy every 4 weeks.
Random allocation means treatment assignment was intended to be determined by chance, rather than chosen according to participants’ characteristics. Masking is reported as quadruple, but the registry record does not specify which groups of people were masked or how masking was maintained. Parallel assignment means participants were assigned to a treatment group rather than described as switching through all regimens.
The planned primary assessment was at week 60, while the brief study summary describes treatment options over 104 weeks. The registry reports that the study was terminated and that zero participants were analyzed for the primary outcome because of early termination. The reason for termination, the timing of termination relative to participant follow-up, and the extent of outcome collection are not reported in the registry record. Consequently, the planned design does not establish that the planned comparison was completed.
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 | Lucentis® | Bevasiranib 8 Weeks | Bevasiranib 12 Weeks |
|---|---|---|---|
| STARTED | 113 | 112 | 113 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 113 | 112 | 113 |
Reasons for not completing this period:
| Reason | Lucentis® | Bevasiranib 8 Weeks | Bevasiranib 12 Weeks |
|---|---|---|---|
| Study Terminated | 112 | 112 | 112 |
| Not treated | 1 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Zero participants analyzed due to early termination of the study.
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 | Lucentis | Bevasiranib 8 Weeks | Bevasiranib 12 Weeks | Total |
|---|---|---|---|---|---|
| Participants analysed | 113 | 112 | 113 | 338 | |
| Age, Continuous | years | 77.6 (56 to 90) | 77.2 (52 to 95) | 78.3 (57 to 94) | 77.7 (52 to 95) |
| Sex: Female, Male: Female | Participants | 80 | 72 | 59 | 211 |
| Sex: Female, Male: Male | Participants | 33 | 40 | 54 | 127 |
| Region of Enrollment: United States | participants | 61 | 59 | 64 | 184 |
| Region of Enrollment: Austria | participants | 4 | 5 | 4 | 13 |
| Region of Enrollment: Canada | participants | 8 | 10 | 5 | 23 |
| Region of Enrollment: France | participants | 22 | 24 | 20 | 66 |
| Region of Enrollment: Israel | participants | 9 | 7 | 6 | 22 |
| Region of Enrollment: Italy | participants | 5 | 2 | 2 | 9 |
| Region of Enrollment: Portugal | participants | 3 | 3 | 5 | 11 |
| Region of Enrollment: Spain | participants | 1 | 2 | 7 | 10 |
6. Primary Endpoint
The registry lists the primary outcome as Visual Acuity, measured over week 60.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is titled Visual Acuity. Its description defines the outcome as avoidance of three or more lines of vision loss, with assessment at week 60. In plain terms, it focuses on whether participants avoided a substantial decline on the vision measure used by the study. The registry does not identify the specific visual-acuity scale, the exact scoring rule, or the operational definition of a line of vision in the outcome entry.
Vision is relevant to a study of exudative age-related macular degeneration because the treatment strategies are being compared in relation to visual function. The endpoint’s threshold turns a change in visual acuity into a defined outcome category: participants either meet the stated avoidance criterion or do not. A defined endpoint can make the clinical question more explicit than an unspecified change in vision, but its interpretation still depends on how the scale was measured, when assessments were obtained, and how missing observations were handled. Those details are not reported in the registry record.
The endpoint is set at week 60, but no participant was analyzed for it according to the registry. There is therefore no posted estimate of how many participants met the criterion, no between-group contrast, and no precision measure such as a confidence interval. The outcome definition identifies what the study intended to assess; it does not provide evidence about the comparative result.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive fact is that the registry reports zero participants analyzed for the primary visual-acuity outcome because the study ended early. No arm-level primary-outcome counts, treatment-effect estimate, confidence interval, or test result is reported. The registry therefore does not show whether avoidance of three or more lines of vision loss differed among Lucentis monotherapy and the two bevasiranib maintenance strategies.
This absence of an analyzed primary outcome is not equivalent to a finding of no difference. A result indicating little or no difference would require an estimate based on observed outcome data, together with enough information to assess its uncertainty. Here, the registry gives no such estimate. Nor can the record support a claim that either strategy performed better or worse on the primary endpoint. The intended comparison and the observed evidence are distinct: the study was designed to ask a question, but the posted record does not report an analyzed answer.
The record lists enrollment of 338, but that figure alone does not establish how many participants were assigned to each arm, received treatment, completed follow-up, or contributed to any particular outcome. The adverse-event groups list 112 at risk in each of the three groups. Those safety denominators should not be treated as proof that the primary outcome was analyzed for those participants: the primary outcome entry explicitly reports zero analyzed. The record does not explain the relationship between enrollment, the safety populations, and the primary-outcome population.
There are no posted primary-outcome estimates to interpret for statistical precision. A confidence interval, when reported, expresses a range of effect values compatible with the data and analysis under the stated method; its width helps convey uncertainty. No confidence interval is reported for this endpoint. Likewise, a p-value would not replace the effect estimate or show the magnitude of any difference, and no primary-outcome p-value is reported. The registry lists zero analyses, which means no recorded analysis result is available for interpretation.
Safety information is reported separately. The adverse-event entry gives numbers affected by serious and other adverse events in each group, and lists several serious-event terms with percentages. These counts describe the posted safety record; they do not establish a causal comparison between groups. Without detailed definitions, event-level data, follow-up information, and an analysis plan, differences in counts cannot be attributed to treatment or interpreted as comparative risks. The registry’s safety entries do not fill the gap in the primary efficacy outcome.
Accordingly, the most defensible interpretation is limited: this was a randomized study intended to compare three treatment strategies, but the registry’s primary-outcome record contains no analyzed participants and no treatment-effect estimate. The reasons and consequences of early termination beyond the stated zero analyzed are not reported in the registry record. Any stronger conclusion about the visual-acuity comparison would go beyond the posted results.
9. Statistical Methods Explained
Statistical methods describe how a trial turns collected observations into estimates and how uncertainty is assessed. For this study, the registry identifies random allocation, masking, parallel assignment, and the intended primary outcome. It does not report a statistical analysis plan, a primary-outcome model, an estimand, or a completed primary analysis. The planned design and the analysis actually available in the record must therefore be kept separate.
What randomization contributes
In general, random allocation aims to make treatment groups comparable at the start of a study, on average, by assigning treatment through chance. This can reduce systematic differences in measured and unmeasured characteristics, but it does not guarantee balance in every realized trial. It also cannot address problems arising after assignment, such as differential follow-up or incomplete outcome collection. The registry says participants were assigned at random but does not report the allocation sequence, concealment procedure, or group-specific assignment counts.
What masking contributes
In general, masking can reduce the influence of treatment knowledge on participant experiences, clinical decisions, outcome assessment, and reporting. The registry describes the study as quadruple-masked. It does not specify which people were masked, whether the masking remained intact, or how treatments with different schedules were made indistinguishable. The label identifies a design feature, not evidence that masking succeeded in practice.
What the endpoint would require
The primary outcome is a threshold-based visual-acuity measure at week 60: avoidance of three or more lines of vision loss. To estimate a group comparison, an analysis would need outcome data and a rule for assigning participants to outcome categories. It would also need to define the analysis population, handle missing assessments, and specify whether the comparison used an unadjusted or adjusted method. These analytic details are not reported in the registry record. Since the registry states that zero participants were analyzed for this outcome, no estimate can be reconstructed from the posted primary-outcome entry.
A confidence interval is a general statistical device for expressing uncertainty around an estimate. It represents values that remain compatible with the observed data and analysis under the method’s assumptions. A narrow interval indicates greater precision than a wide one, while neither width nor position alone explains clinical importance. No primary-outcome estimate or interval is reported, so precision cannot be assessed.
Why the absence of an analysis matters
In general, a test statistic or p-value evaluates data relative to a null hypothesis under specified assumptions. A p-value is not the probability that a treatment works, and it does not show the size or practical importance of an effect. It is also not interpretable as a primary comparison when the corresponding analyzed observations and method are unavailable. The registry lists zero analyses and provides no primary-outcome test result. Thus there is no statistical test to interpret for the stated endpoint.
Enrollment and analysis populations are not interchangeable. Enrollment describes the participants entered into the study, whereas an analysis population depends on the analysis definition and available data. A randomized-trial analysis might, in general, include all assigned participants or a selected population defined by protocol, but the registry does not report which approach was planned. The enrollment figure alone cannot identify who contributed to a primary endpoint analysis, and the record explicitly says none did.
Safety counts and statistical comparison
The adverse-event record lists the numbers at risk and affected in each group. Counts can be useful descriptions, but they do not by themselves provide a complete comparative analysis. Interpretation depends on event definitions, the time participants were observed, whether events could be counted more than once, and the statistical method used. The registry does not report these details. It also does not provide adjusted comparisons or uncertainty estimates for the serious or other adverse-event counts.
For the same reason, the listed percentages for serious-event terms should be read as registry-reported values, not as evidence of a treatment effect. The registry does not state their arm-specific distribution or provide the denominator and calculation details for each term in the listed entry. No additional comparative rates should be inferred from those percentages.
Sample-size planning is also distinct from analysis. In general, planning calculations depend on assumptions about the effect to detect, outcome variability or event frequency, significance level, power, and allocation. The registry record does not report the trial’s own sample-size justification or statistical plan. The planning illustration described in the record is not a substitute for the sponsor’s design justification or an observed treatment result. A planning sample size cannot establish what the trial found, and it is not observed power.
Finally, early termination can affect the amount and completeness of outcome data available for analysis. Its statistical consequences depend on why the study stopped, when it stopped, and how termination related to outcome information. Those details are not reported in the registry record. No interim-analysis procedure or stopping rule is reported either. Without them, the record does not support claims about whether interim monitoring changed the analysis or the interpretation.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary visual-acuity outcome and secondary outcomes concerning need for rescue therapy, time to rescue therapy, and the number of patients with a gain of three or more lines in vision. It does not report a multiplicity plan describing how results across these outcomes or treatment comparisons would be interpreted together. In general, testing multiple hypotheses can increase the chance of obtaining at least one apparently notable result by chance. A prespecified strategy can address that issue, but no such strategy is reported in the registry record.
The primary outcome entry states that zero participants were analyzed because of early termination. The record does not provide outcome-level missingness, reasons for missing assessments, or a method for handling missing data. It does not say whether participants who stopped treatment or withdrew would remain in an analysis, or how incomplete follow-up would be handled. These details matter because missing outcomes can affect both the estimate and its uncertainty, especially if missingness differs between groups or relates to participants’ outcomes.
The analysis populations are not reported in the registry record. The record does not identify an intention-to-treat population, a per-protocol population, or another defined set of participants for the primary comparison. Enrollment of 338 does not identify the analysis set; the primary outcome entry instead records zero participants analyzed.
The registry does not report a statistical analysis plan, interim analyses, stopping rules, or a sample-size justification. It identifies the study as terminated but does not give the reason or explain whether any planned analyses were conducted before termination. With no reported primary analysis and no information on missing-data or multiplicity procedures, the treatment comparisons cannot be evaluated statistically from the registry 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 |
|---|---|---|---|
| Lucentis | 26 | 112 | 23.2% |
| Bevasiranib 8 Weeks | 28 | 112 | 25.0% |
| Bevasiranib 12 Weeks | 33 | 112 | 29.5% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Lucentis | 71 of 112 |
| Bevasiranib 8 Weeks | 85 of 112 |
| Bevasiranib 12 Weeks | 96 of 112 |
Most frequent serious adverse event terms
| Event term | Organ system | Lucentis | Bevasiranib 8 Weeks | Bevasiranib 12 Weeks |
|---|---|---|---|---|
| Visual acuity decreased | Eye disorders | 5 of 112 | 7 of 112 | 10 of 112 |
| Endophthalmitis | Eye disorders | 0 of 112 | 4 of 112 | 1 of 112 |
| Cerebrovascular accident | Nervous system disorders | 2 of 112 | 0 of 112 | 2 of 112 |
| Uveitis | Eye disorders | 0 of 112 | 1 of 112 | 2 of 112 |
| Vitritis | Eye disorders | 0 of 112 | 3 of 112 | 0 of 112 |
| Pneumonia | Infections and infestations | 1 of 112 | 0 of 112 | 2 of 112 |
| Atrial fibrillation | Cardiac disorders | 1 of 112 | 1 of 112 | 0 of 112 |
| Myocardial infarction | Cardiac disorders | 1 of 112 | 1 of 112 | 0 of 112 |
| Vitreous haemorrhage | Eye disorders | 0 of 112 | 0 of 112 | 2 of 112 |
| Back pain | Musculoskeletal and connective tissue disorders | 1 of 112 | 1 of 112 | 0 of 112 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Lucentis | Bevasiranib 8 Weeks | Bevasiranib 12 Weeks |
|---|---|---|---|---|
| Retinal haemorrhage | Eye disorders | 11 of 112 | 16 of 112 | 22 of 112 |
| Conjunctival haemorrhage | Eye disorders | 10 of 112 | 9 of 112 | 13 of 112 |
| Vitreous detachment | Eye disorders | 8 of 112 | 11 of 112 | 10 of 112 |
| Vitreous floaters | Eye disorders | 9 of 112 | 10 of 112 | 8 of 112 |
| Eye pain | Eye disorders | 6 of 112 | 7 of 112 | 12 of 112 |
| Visual acuity reduced | Eye disorders | 4 of 112 | 8 of 112 | 12 of 112 |
| Macular degeneration | Eye disorders | 5 of 112 | 7 of 112 | 9 of 112 |
| Intraocular pressure increased | Investigations | 3 of 112 | 7 of 112 | 10 of 112 |
| Cataract | Eye disorders | 8 of 112 | 4 of 112 | 6 of 112 |
| Nasopharyngitis | Infections and infestations | 7 of 112 | 6 of 112 | 5 of 112 |
Serious events with the highest arm-level rate: visual acuity decreased (8.9%), endophthalmitis (3.6%), vitritis (2.7%), uveitis (1.8%), vitreous haemorrhage (1.8%).
The registry’s adverse-event entry lists three groups: Lucentis, Bevasiranib 8 Weeks, and Bevasiranib 12 Weeks. Each group lists 112 participants at risk for serious adverse events and 112 at risk for other adverse events. The numbers affected by serious adverse events are 26, 28, and 33, respectively, in the order listed. The numbers affected by other adverse events are 71, 85, and 96, in that same order. These are descriptive counts as recorded, not adjusted estimates of comparative risk.
The registry also lists serious-event terms with percentages: Visual acuity decreased, 8.9%; Endophthalmitis, 3.6%; Vitritis, 2.7%; Uveitis, 1.8%; Vitreous haemorrhage, 1.8%; and Pneumonia, 1.8%. The entry does not assign these term percentages to particular arms. They should therefore not be read as arm-specific percentages or used to rank treatment groups.
Safety comparisons require context about definitions, observation time, event counting, and participant exposure. Those details and uncertainty estimates are not reported in the registry record. The death entries are not reported in the registry record. The posted counts describe what the registry lists; they do not establish that treatment caused an event or that groups differed statistically.
12. What the Result Does, and Does Not, Mean
The record establishes that NCT00499590 was intended to compare Lucentis every 4 weeks with bevasiranib maintenance every 8 weeks or every 12 weeks following Lucentis pretreatment. It identifies a visual-acuity primary endpoint at week 60, defined as avoidance of three or more lines of vision loss. It also records randomization, quadruple masking, parallel assignment, enrollment of 338, and a terminated study.
What the record does not establish is the result of the primary comparison. It says that zero participants were analyzed for the primary outcome because of early termination. No group-specific endpoint results, effect estimate, confidence interval, or test result are reported. The treatment strategies therefore cannot be ranked using the posted primary-outcome evidence. This is an absence of an analyzed result, not evidence that the strategies had equal outcomes or that a particular strategy was superior or inferior.
The safety entries provide counts of participants affected by serious and other adverse events, along with a list of serious-event terms and percentages. They are not a complete comparative safety analysis: the registry does not provide event-level context, arm assignment for the listed term percentages, or uncertainty estimates. The entries should be read as descriptive registry data rather than a causal assessment.
Early termination is an important part of interpreting the record, but the reason for termination and its timing are not reported. Without those details, it is not possible to assess why the planned comparison was not analyzed or how the termination affected follow-up. The record also does not report the analysis populations, missing-data methods, or statistical plan.
In general, a trial’s stated purpose, design, and intended endpoint describe the question it sought to answer. They are not themselves evidence of an answer. For this study, the registry documents the planned comparison and some safety counts, but it does not report an analyzed primary visual-acuity result. Conclusions about comparative effectiveness or precise treatment effects would exceed what the posted record supports.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the difference between a trial’s design and an interpretable treatment-effect result. Randomization and masking describe methods intended to improve the credibility of a comparison. They do not guarantee that a usable comparison will be available if the study ends before the primary outcome is analyzed. The registry’s statement that zero participants were analyzed for the primary outcome makes that distinction especially important.
The primary endpoint is defined in clinical terms, but the registry does not pair it with analyzed outcomes or an estimate of uncertainty. That means the reader cannot assess either the direction or the precision of the intended comparison. A well-specified question is necessary for statistical interpretation, but it is not sufficient: the outcome data, analysis population, analysis method, and estimate are also needed.
The record also illustrates why enrollment totals and safety denominators should not be treated as substitutes for endpoint analysis. Enrollment of 338 is a design-level fact. The safety entry lists participants at risk and affected by adverse events. Neither supplies a visual-acuity comparison, and the registry explicitly reports no primary-outcome participants analyzed. Keeping these types of information separate prevents descriptive counts from being mistaken for an efficacy result.
Finally, a terminated study with limited reported analysis raises questions that a registry record may not resolve, including the reason for termination, the completeness of follow-up, and the intended handling of missing outcomes. Those details affect how confidently findings can be interpreted when results are available. Here, the most important statistical conclusion is a boundary: the posted record documents the planned question and selected safety information, but it does not provide a primary-outcome estimate from which to draw a comparative conclusion.
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 interpreting this trial is that the registry reports zero participants analyzed for the primary outcome because the study ended early. It provides no group-specific results for avoidance of three or more lines of vision loss, no treatment-effect estimate, and no measure of uncertainty. Consequently, the intended visual-acuity comparison cannot be assessed from the posted results.
The reason for termination and the timing of the decision are not reported in the registry record. The record also does not state how many participants were assigned to each group, how many received treatment, or how many completed follow-up. Although safety entries list 112 participants at risk per group, those figures do not resolve the lack of primary-outcome analysis.
Several methods needed for a fuller assessment are not reported in the registry record: the statistical analysis plan, analysis populations, missing-data procedures, sample-size justification, and any interim analyses or stopping rules. The outcome entry does not identify the specific visual-acuity scale or give detailed measurement and classification procedures. Masking is described as quadruple, but the record does not specify who was masked or whether masking was maintained.
The adverse-event entry gives counts and serious-event terms, but does not provide enough detail for a complete comparative safety assessment. It does not report arm assignment for the listed percentages, event-level timing, or uncertainty estimates. Death information is not reported in the registry record. These limitations constrain interpretation of the safety data independently of the absent primary efficacy result.
Overall, the registry identifies the planned design and some descriptive safety information, but key information about conduct, follow-up, analysis, and the reason for early termination is not reported. These gaps prevent a comprehensive assessment of the trial’s comparative findings.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD — NCT00499590.
- Registry record last updated 2014-10-06; status last verified 2014-09.
- Results first posted 2014-10-06.
- 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
NCT00499590 was a phase 3 randomized, quadruple-masked, parallel-assignment study sponsored by OPKO Health, Inc. It planned to compare Lucentis 0.5mg every 4 weeks with bevasiranib 2.5mg maintenance every 8 weeks or every 12 weeks after Lucentis pretreatment and bevasiranib priming doses. The registry lists enrollment of 338 and a planned duration of 104 weeks.
The primary outcome was visual acuity at week 60, defined as avoidance of three or more lines of vision loss. The study status is terminated, and the registry states that zero participants were analyzed for the primary outcome because of early termination. It therefore reports no primary-outcome treatment comparison. Secondary outcomes listed concern rescue therapy and vision gain. Safety entries report serious and other adverse-event counts, but do not provide a complete comparative analysis. The reason for termination and key analysis details are not reported in the registry record.